Trial Outcomes & Findings for Post Operative Adjuvant Therapy De-intensification Trial for Human Papillomavirus-related, p16+ Oropharynx Cancer (NCT NCT01687413)

NCT ID: NCT01687413

Last Updated: 2020-11-25

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 42 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2020-11-25

Participant Flow

Participant milestones

Measure	Radiotherapy * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	Radiotherapy, Cisplatin * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways
Overall Study STARTED	27	15
Overall Study COMPLETED	26	11
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Measure	Radiotherapy * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	Radiotherapy, Cisplatin * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways
Overall Study Withdrawal by Subject	0	2
Overall Study Not eligible	0	2
Overall Study Patient withdrew before completing all radiotherapy	1	0

Baseline Characteristics

Post Operative Adjuvant Therapy De-intensification Trial for Human Papillomavirus-related, p16+ Oropharynx Cancer

Baseline characteristics by cohort

Measure	Radiotherapy n=27 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	Radiotherapy, Cisplatin n=15 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	Total n=42 Participants Total of all reporting groups
Age, Continuous	56 years n=5 Participants	55 years n=7 Participants	56 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	12 Participants n=7 Participants	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants	15 Participants n=7 Participants	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	14 Participants n=7 Participants	40 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants	15 participants n=7 Participants	42 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Outcome measures

Measure	Radiotherapy n=24 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	Radiotherapy, Cisplatin n=11 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	1 Month - Radiotherapy * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	1 Month - Radiotherapy + Cisplatin * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	6 Months - Radiotherapy * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	6 Months - Radiotherapy + Cisplatin * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	12 Months - Radiotherapy * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	12 Months - Radiotherapy + Cisplatin * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	24 Months - Radiotherapy * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	24 Months - Radiotherapy + Cisplatin * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways
Number of Participants With Disease-free Survival (DFS)	24 Participants	10 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to 2 years

Rate of patients with no recurrence at original oropharyngeal site or in the neck nodal basins.

Outcome measures

Measure	Radiotherapy n=27 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	Radiotherapy, Cisplatin n=11 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	1 Month - Radiotherapy * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	1 Month - Radiotherapy + Cisplatin * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	6 Months - Radiotherapy * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	6 Months - Radiotherapy + Cisplatin * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	12 Months - Radiotherapy * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	12 Months - Radiotherapy + Cisplatin * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	24 Months - Radiotherapy * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	24 Months - Radiotherapy + Cisplatin * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways
Locoregional Control	26 Participants	9 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 2 years

Assessed by biopsy or imaging-detected recurrent disease at sites away from the original primary and cervical zone.

Outcome measures

Measure	Radiotherapy n=27 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	Radiotherapy, Cisplatin n=11 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	1 Month - Radiotherapy * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	1 Month - Radiotherapy + Cisplatin * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	6 Months - Radiotherapy * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	6 Months - Radiotherapy + Cisplatin * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	12 Months - Radiotherapy * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	12 Months - Radiotherapy + Cisplatin * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	24 Months - Radiotherapy * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	24 Months - Radiotherapy + Cisplatin * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways
Rate of Distant Metastasis	2 Participants	0 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure	Radiotherapy n=24 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	Radiotherapy, Cisplatin n=10 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	1 Month - Radiotherapy * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	1 Month - Radiotherapy + Cisplatin * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	6 Months - Radiotherapy * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	6 Months - Radiotherapy + Cisplatin * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	12 Months - Radiotherapy * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	12 Months - Radiotherapy + Cisplatin * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	24 Months - Radiotherapy * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	24 Months - Radiotherapy + Cisplatin * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways
Disease Specific Survival	24 Participants	10 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Approximately 18 weeks

Population: One participant in each Arm did not have adverse events collected.

-Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Outcome measures

Measure	Radiotherapy n=26 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	Radiotherapy, Cisplatin n=10 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	1 Month - Radiotherapy * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	1 Month - Radiotherapy + Cisplatin * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	6 Months - Radiotherapy * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	6 Months - Radiotherapy + Cisplatin * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	12 Months - Radiotherapy * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	12 Months - Radiotherapy + Cisplatin * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	24 Months - Radiotherapy * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	24 Months - Radiotherapy + Cisplatin * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways
Number of Complications/Acute Toxicity by Organ Class Blood and lymphatic system disorders	5 number of adverse events	12 number of adverse events	—	—	—	—	—	—	—	—
Number of Complications/Acute Toxicity by Organ Class Cardiac disorders	0 number of adverse events	1 number of adverse events	—	—	—	—	—	—	—	—
Number of Complications/Acute Toxicity by Organ Class Ear and labyrinth disorders	11 number of adverse events	4 number of adverse events	—	—	—	—	—	—	—	—
Number of Complications/Acute Toxicity by Organ Class Eye disorders	2 number of adverse events	0 number of adverse events	—	—	—	—	—	—	—	—
Number of Complications/Acute Toxicity by Organ Class Gastrointestinal disorders	104 number of adverse events	61 number of adverse events	—	—	—	—	—	—	—	—
Number of Complications/Acute Toxicity by Organ Class General disorders	38 number of adverse events	17 number of adverse events	—	—	—	—	—	—	—	—
Number of Complications/Acute Toxicity by Organ Class Immune system disorders	1 number of adverse events	0 number of adverse events	—	—	—	—	—	—	—	—
Number of Complications/Acute Toxicity by Organ Class Infections and infestations	7 number of adverse events	2 number of adverse events	—	—	—	—	—	—	—	—
Number of Complications/Acute Toxicity by Organ Class Injury, poisoning and procedureal complications	31 number of adverse events	9 number of adverse events	—	—	—	—	—	—	—	—
Number of Complications/Acute Toxicity by Organ Class Investigations	20 number of adverse events	60 number of adverse events	—	—	—	—	—	—	—	—
Number of Complications/Acute Toxicity by Organ Class Metabolism and nutrition disorders	11 number of adverse events	26 number of adverse events	—	—	—	—	—	—	—	—
Number of Complications/Acute Toxicity by Organ Class Musculoskeletal and connective tissue disorders	15 number of adverse events	9 number of adverse events	—	—	—	—	—	—	—	—
Number of Complications/Acute Toxicity by Organ Class Neoplasms benign, malignant and unspecified (incl cysts and polyps)	1 number of adverse events	0 number of adverse events	—	—	—	—	—	—	—	—
Number of Complications/Acute Toxicity by Organ Class Nervous system disorders	48 number of adverse events	29 number of adverse events	—	—	—	—	—	—	—	—
Number of Complications/Acute Toxicity by Organ Class Psychiatric disorders	16 number of adverse events	9 number of adverse events	—	—	—	—	—	—	—	—
Number of Complications/Acute Toxicity by Organ Class Respiratory, thoracic and mediastinal disorders	34 number of adverse events	14 number of adverse events	—	—	—	—	—	—	—	—
Number of Complications/Acute Toxicity by Organ Class Skin and subcutaneous tissue disorders	32 number of adverse events	14 number of adverse events	—	—	—	—	—	—	—	—
Number of Complications/Acute Toxicity by Organ Class Surgical and medical procedures	3 number of adverse events	0 number of adverse events	—	—	—	—	—	—	—	—
Number of Complications/Acute Toxicity by Organ Class Vascular disorders	11 number of adverse events	6 number of adverse events	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 1 month, 6 months, 12 months, and 24 months

Population: Some participants were not analyzed as the participants did not complete the questionnaires.

• Each item is scored on a 5 point Likert scale (strongly disagree, disagree, no opinion, agree, strongly agree). Strongly agree = 1, Disagree = 2, No opinion = 3, Agree = 4, and Strongly Agree = 5
• The lower the score the lower the quality of life

Outcome measures

Measure	Radiotherapy n=23 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	Radiotherapy, Cisplatin n=11 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	1 Month - Radiotherapy n=22 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	1 Month - Radiotherapy + Cisplatin n=11 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	6 Months - Radiotherapy n=13 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	6 Months - Radiotherapy + Cisplatin n=7 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	12 Months - Radiotherapy n=15 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	12 Months - Radiotherapy + Cisplatin n=7 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	24 Months - Radiotherapy n=17 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	24 Months - Radiotherapy + Cisplatin n=8 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways
Change in Quality of Life as Measured by the MD Anderson Dysphagia Inventory My swallowing ability limits my day to day activities.	3.2608696 score on a scale Standard Deviation 1.3888318	4.0000000 score on a scale Standard Deviation 1.0954451	4.1818182 score on a scale Standard Deviation 1.2203186	4.1818182 score on a scale Standard Deviation 1.1677484	4.3076923 score on a scale Standard Deviation 0.9473309	3.5714286 score on a scale Standard Deviation 1.5118579	4.5000000 score on a scale Standard Deviation 0.6504436	3.2857143 score on a scale Standard Deviation 1.6035675	3.9375000 score on a scale Standard Deviation 1.3889444	4.6250000 score on a scale Standard Deviation 0.5175492
Change in Quality of Life as Measured by the MD Anderson Dysphagia Inventory I do not feel self-conscious when I eat.	3.3913043 score on a scale Standard Deviation 1.3395769	4.0909091 score on a scale Standard Deviation 1.2210279	3.9090909 score on a scale Standard Deviation 1.1087999	4.1818182 score on a scale Standard Deviation 0.9816498	4.3846154 score on a scale Standard Deviation 0.9607689	3.7142857 score on a scale Standard Deviation 1.1126973	4.0769231 score on a scale Standard Deviation 1.3204506	3.7142857 score on a scale Standard Deviation 1.2535663	3.6875000 score on a scale Standard Deviation 1.3022417	4.5000000 score on a scale Standard Deviation 0.7559289
Change in Quality of Life as Measured by the MD Anderson Dysphagia Inventory I am upset by my swallowing problem.	3.2272727 score on a scale Standard Deviation 1.6599431	2.0909091 score on a scale Standard Deviation 1.5135749	2.8636364 score on a scale Standard Deviation 1.6123173	2.6363636 score on a scale Standard Deviation 1.3618170	3.1538462 score on a scale Standard Deviation 1.6756170	2.2857143 score on a scale Standard Deviation 1.2535663	2.7857143 score on a scale Standard Deviation 1.6723347	3.1428571 score on a scale Standard Deviation 1.3451854	3.0625000 score on a scale Standard Deviation 1.7308476	3.2500000 score on a scale Standard Deviation 1.4880476
Change in Quality of Life as Measured by the MD Anderson Dysphagia Inventory I am embarrassed by my eating habits.	3.5454545 score on a scale Standard Deviation 1.2993505	4.4545455 score on a scale Standard Deviation 0.8201995	4.1818182 score on a scale Standard Deviation 1.2587357	4.4545455 score on a scale Standard Deviation 0.5222330	4.3846154 score on a scale Standard Deviation 1.1208971	3.8571429 score on a scale Standard Deviation 0.6900656	4.4285714 score on a scale Standard Deviation 0.7559289	3.1428571 score on a scale Standard Deviation 1.2149858	4.1250000 score on a scale Standard Deviation 1.2041595	4.1250000 score on a scale Standard Deviation 0.6408699
Change in Quality of Life as Measured by the MD Anderson Dysphagia Inventory Swallowing is more difficult at the end of the day.	3.3636364 score on a scale Standard Deviation 1.4974726	4.5454545 score on a scale Standard Deviation 0.6875517	3.8095238 score on a scale Standard Deviation 1.3273676	4.0909091 score on a scale Standard Deviation 0.9438798	4.6153846 score on a scale Standard Deviation 0.8697185	3.8571429 score on a scale Standard Deviation 1.0690450	4.2857143 score on a scale Standard Deviation 1.1387288	4.1428571 score on a scale Standard Deviation 1.0690450	4.4000000 score on a scale Standard Deviation 0.9102590	4.7500000 score on a scale Standard Deviation 0.4629100
Change in Quality of Life as Measured by the MD Anderson Dysphagia Inventory People have difficulty cooking for me.	3.2173913 score on a scale Standard Deviation 1.5062452	3.9090909 score on a scale Standard Deviation 1.2210279	3.7727273 score on a scale Standard Deviation 1.3777766	4.2727273 score on a scale Standard Deviation 1.0090500	3.7692308 score on a scale Standard Deviation 1.4806444	3.1428571 score on a scale Standard Deviation 1.2149858	4.2142857 score on a scale Standard Deviation 1.1883131	3.7142857 score on a scale Standard Deviation 1.3801311	3.9375000 score on a scale Standard Deviation 1.3400871	4.1250000 score on a scale Standard Deviation 0.6408699
Change in Quality of Life as Measured by the MD Anderson Dysphagia Inventory Swallowing takes great effort.	3.0869565 score on a scale Standard Deviation 1.5049326	3.4545455 score on a scale Standard Deviation 1.2135598	3.9545455 score on a scale Standard Deviation 1.0455016	3.9090909 score on a scale Standard Deviation 1.2210279	3.6923077 score on a scale Standard Deviation 1.3155870	3.0000000 score on a scale Standard Deviation 1.1547005	3.9285714 score on a scale Standard Deviation 1.3847680	3.1428571 score on a scale Standard Deviation 1.5735916	3.5625000 score on a scale Standard Deviation 1.2632630	3.3750000 score on a scale Standard Deviation 1.4078860
Change in Quality of Life as Measured by the MD Anderson Dysphagia Inventory I do not go out because of my swallowing problem.	3.9130435 score on a scale Standard Deviation 0.9960396	4.6363636 score on a scale Standard Deviation 0.5045250	4.3181818 score on a scale Standard Deviation 0.9454837	4.1818182 score on a scale Standard Deviation 0.9816498	4.5384615 score on a scale Standard Deviation 0.8770580	3.8571429 score on a scale Standard Deviation 1.0690450	4.6428571 score on a scale Standard Deviation 0.6333237	4.1428571 score on a scale Standard Deviation 1.0690450	4.1875000 score on a scale Standard Deviation 1.0468206	4.2500000 score on a scale Standard Deviation 0.8864053
Change in Quality of Life as Measured by the MD Anderson Dysphagia Inventory My swallowing difficulty has caused me to lose income.	4.2608696 score on a scale Standard Deviation 1.0538842	3.9090909 score on a scale Standard Deviation 1.7002674	4.5000000 score on a scale Standard Deviation 0.7400129	4.3636364 score on a scale Standard Deviation 0.8090398	4.6153846 score on a scale Standard Deviation 0.6504436	4.0000000 score on a scale Standard Deviation 1.1547005	4.6428571 score on a scale Standard Deviation 0.6333237	3.8571429 score on a scale Standard Deviation 1.2149858	4.6000000 score on a scale Standard Deviation 0.6324555	4.5000000 score on a scale Standard Deviation 0.7559289
Change in Quality of Life as Measured by the MD Anderson Dysphagia Inventory It takes me longer to eat because of my swallowing problem.	2.5909091 score on a scale Standard Deviation 1.4690162	2.4000000 score on a scale Standard Deviation 1.4298407	3.1818182 score on a scale Standard Deviation 1.5625487	2.9090909 score on a scale Standard Deviation 1.7002674	3.0769231 score on a scale Standard Deviation 1.4978617	2.1428571 score on a scale Standard Deviation 0.8997354	3.5000000 score on a scale Standard Deviation 1.6052798	3.0000000 score on a scale Standard Deviation 1.9148542	2.8750000 score on a scale Standard Deviation 1.5438048	3.1250000 score on a scale Standard Deviation 1.6420806
Change in Quality of Life as Measured by the MD Anderson Dysphagia Inventory People ask me, "Why can't you eat that?"	4.0869565 score on a scale Standard Deviation 1.1246431	4.0000000 score on a scale Standard Deviation 1.1547005	4.0000000 score on a scale Standard Deviation 1.2344268	3.7272727 score on a scale Standard Deviation 1.3483997	4.1538462 score on a scale Standard Deviation 1.2810252	3.4285714 score on a scale Standard Deviation 1.1338934	4.2142857 score on a scale Standard Deviation 1.1883131	3.0000000 score on a scale Standard Deviation 1.6329932	4.1875000 score on a scale Standard Deviation 1.3275918	4.5000000 score on a scale Standard Deviation 0.9258201
Change in Quality of Life as Measured by the MD Anderson Dysphagia Inventory Other people are irritated by my eating problem.	4.2608696 score on a scale Standard Deviation 0.8643122	4.2727273 score on a scale Standard Deviation 1.0090500	4.5454545 score on a scale Standard Deviation 0.7385489	4.3636364 score on a scale Standard Deviation 0.8090398	4.6923077 score on a scale Standard Deviation 0.6304252	3.8571429 score on a scale Standard Deviation 0.6900656	4.5714286 score on a scale Standard Deviation 0.7559289	4.1428571 score on a scale Standard Deviation 0.8997354	4.3750000 score on a scale Standard Deviation 0.8062258	4.3750000 score on a scale Standard Deviation 0.9161254

SECONDARY outcome

Timeframe: Baseline, 1 month, 12 months, and 24 months

Population: Some participants were not analyzed as the participants did not complete the questionnaires.

• 25 questions to assess the frequency in which participants experience cognitive failures including forgetfulness, distractibility, and false triggering
• Answers range from 0 = never to 4 = very often
• The higher the score the worse the cognitive failures the participant has experienced

Outcome measures

Measure	Radiotherapy n=24 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	Radiotherapy, Cisplatin n=11 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	1 Month - Radiotherapy n=22 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	1 Month - Radiotherapy + Cisplatin n=11 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	6 Months - Radiotherapy n=16 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	6 Months - Radiotherapy + Cisplatin n=7 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	12 Months - Radiotherapy n=17 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	12 Months - Radiotherapy + Cisplatin n=8 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	24 Months - Radiotherapy * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	24 Months - Radiotherapy + Cisplatin * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways
Change in Cognitive Function as Measured by Cognitive Failures Questionnaire Do you find you forget why you went from one part of the house to the other?	1.2083333 score on a scale Standard Deviation 0.9770927	1.0909091 score on a scale Standard Deviation 0.9438798	1.2727273 score on a scale Standard Deviation 1.1621744	1.0000000 score on a scale Standard Deviation 1.0000000	1.333333 score on a scale Standard Deviation 1.3451854	1.5000000 score on a scale Standard Deviation 0.8366600	1.4375000 score on a scale Standard Deviation 0.8920949	1.4285714 score on a scale Standard Deviation 1.2724180	—	—
Change in Cognitive Function as Measured by Cognitive Failures Questionnaire Do you fail to notice signposts on the road?	0.6666667 score on a scale Standard Deviation 0.9168313	0.3636364 score on a scale Standard Deviation 0.6741999	0.7272727 score on a scale Standard Deviation 0.9847319	0.5454545 score on a scale Standard Deviation 0.6875517	0.6666667 score on a scale Standard Deviation 0.6172134	0.8333333 score on a scale Standard Deviation 0.7527727	0.6250000 score on a scale Standard Deviation 0.6191392	0.8571429 score on a scale Standard Deviation 1.0690450	—	—
Change in Cognitive Function as Measured by Cognitive Failures Questionnaire Do you find you confuse right and left when giving directions?	0.3333333 score on a scale Standard Deviation 0.8681147	0.2727273 score on a scale Standard Deviation 0.4670994	0.4545455 score on a scale Standard Deviation 0.9116846	0.2727273 score on a scale Standard Deviation 0.6466698	0.2666667 score on a scale Standard Deviation 0.5936168	0.3333333 score on a scale Standard Deviation 0.5163978	0.3750000 score on a scale Standard Deviation 0.6191392	0.5714286 score on a scale Standard Deviation 0.7867958	—	—
Change in Cognitive Function as Measured by Cognitive Failures Questionnaire Do you have trouble making up your mind?	0.9583333 score on a scale Standard Deviation 1.0826363	0.9090909 score on a scale Standard Deviation 1.0444659	1.0000000 score on a scale Standard Deviation 1.1126973	0.9090909 score on a scale Standard Deviation 0.9438798	0.9333333 score on a scale Standard Deviation 0.9611501	1.0000000 score on a scale Standard Deviation 1.0954451	1.0625000 score on a scale Standard Deviation 0.9287088	1.1428571 score on a scale Standard Deviation 1.2149858	—	—
Change in Cognitive Function as Measured by Cognitive Failures Questionnaire Do you find you forget appointments?	0.5833333 score on a scale Standard Deviation 0.9743076	0.5454545 score on a scale Standard Deviation 0.6875517	0.7727273 score on a scale Standard Deviation 1.1097755	0.6363636 score on a scale Standard Deviation 0.6741999	0.5333333 score on a scale Standard Deviation 0.8338094	0.8333333 score on a scale Standard Deviation 0.7527727	0.6250000 score on a scale Standard Deviation 0.6191392	1.0000000 score on a scale Standard Deviation 1.1547005	—	—
Change in Cognitive Function as Measured by Cognitive Failures Questionnaire Do you find you forget people's names?	1.8333333 score on a scale Standard Deviation 1.1671842	1.6363636 score on a scale Standard Deviation 1.5015144	1.8636364 score on a scale Standard Deviation 1.3556040	1.6363636 score on a scale Standard Deviation 1.1200649	2.0666667 score on a scale Standard Deviation 1.3345233	1.6666667 score on a scale Standard Deviation 1.0327956	1.8125000 score on a scale Standard Deviation 0.9105859	1.8571429 score on a scale Standard Deviation 1.3451854	—	—
Change in Cognitive Function as Measured by Cognitive Failures Questionnaire Do you find you can't quite remember something although it's on the tip of your tongue?	1.4166667 score on a scale Standard Deviation 0.9743076	1.4545455 score on a scale Standard Deviation 1.2135598	1.8181818 score on a scale Standard Deviation 0.8528029	1.2727273 score on a scale Standard Deviation 0.9045340	1.7333333 score on a scale Standard Deviation 1.0327956	2.0000000 score on a scale Standard Deviation 0.6324555	1.6250000 score on a scale Standard Deviation 0.6191392	1.5714286 score on a scale Standard Deviation 1.3972763	—	—
Change in Cognitive Function as Measured by Cognitive Failures Questionnaire Do you forget where you put something like a newspaper or a book?	1.0416667 score on a scale Standard Deviation 0.8064504	1.00000000 score on a scale Standard Deviation 0.8944272	1.1363636 score on a scale Standard Deviation 1.0371873	0.8181818 score on a scale Standard Deviation 0.7507572	1.4000000 score on a scale Standard Deviation 0.9102590	1.3333333 score on a scale Standard Deviation 0.5163978	1.1250000 score on a scale Standard Deviation 0.7187953	1.5714286 score on a scale Standard Deviation 1.3972763	—	—
Change in Cognitive Function as Measured by Cognitive Failures Questionnaire Do you find you accidentally throw away the thing you want and keep what you meant to throw away?	0.5416667 score on a scale Standard Deviation 1.0623668	0.1818182 score on a scale Standard Deviation 0.4045199	0.5454545 score on a scale Standard Deviation 1.0107646	0.1818182 score on a scale Standard Deviation 0.6030227	0.6666667 score on a scale Standard Deviation 0.7237469	0.3333333 score on a scale Standard Deviation 0.5163978	0.6250000 score on a scale Standard Deviation 0.7187953	0.5714286 score on a scale Standard Deviation 0.7867958	—	—
Change in Cognitive Function as Measured by Cognitive Failures Questionnaire Do you daydream when you out to be listening to something?	1.1250000 score on a scale Standard Deviation 1.0347232	1.2727273 score on a scale Standard Deviation 1.0090500	1.1818182 score on a scale Standard Deviation 1.0064726	0.9090909 score on a scale Standard Deviation 0.8312094	1.0000000 score on a scale Standard Deviation 0.9258201	0.8333333 score on a scale Standard Deviation 1.1690452	1.0000000 score on a scale Standard Deviation 0.7302967	0.8571429 score on a scale Standard Deviation 1.0690450	—	—
Change in Cognitive Function as Measured by Cognitive Failures Questionnaire Do you find yourself suddenly wondering whether you've used a word correctly?	0.5833333 score on a scale Standard Deviation 0.7172815	0.6363636 score on a scale Standard Deviation 0.6741999	0.7727273 score on a scale Standard Deviation 1.0203556	0.6363636 score on a scale Standard Deviation 0.8090398	0.8000000 score on a scale Standard Deviation 0.8618916	0.6666667 score on a scale Standard Deviation 1.2110601	0.7500000 score on a scale Standard Deviation 0.6831301	0.8571429 score on a scale Standard Deviation 0.8997354	—	—
Change in Cognitive Function as Measured by Cognitive Failures Questionnaire Do you leave important letters unanswered for days?	0.6666667 score on a scale Standard Deviation 1.0772203	0.6363636 score on a scale Standard Deviation 1.0269106	1.0000000 score on a scale Standard Deviation 1.0235326	0.4545455 score on a scale Standard Deviation 0.9341987	0.7857143 score on a scale Standard Deviation 0.9749613	0.8333333 score on a scale Standard Deviation 0.7527727	0.8125000 score on a scale Standard Deviation 0.7500000	1.0000000 score on a scale Standard Deviation 1.1547005	—	—
Change in Cognitive Function as Measured by Cognitive Failures Questionnaire Do you find you forget which way to turn on a road you know well but rarely use?	0.4782609 score on a scale Standard Deviation 0.9472239	0.4545455 score on a scale Standard Deviation 0.8201995	0.4090909 score on a scale Standard Deviation 0.9591212	0.5454545 score on a scale Standard Deviation 0.9341987	0.3333333 score on a scale Standard Deviation 0.6172134	0.5000000 score on a scale Standard Deviation 0.8366600	0.3125000 score on a scale Standard Deviation 0.4787136	0.2857143 score on a scale Standard Deviation 0.4879500	—	—
Change in Cognitive Function as Measured by Cognitive Failures Questionnaire Do you read something and find you haven't been thinking about it and must read it again?	1.4166667 score on a scale Standard Deviation 0.9743076	1.3636364 score on a scale Standard Deviation 1.2060454	1.5454545 score on a scale Standard Deviation 1.0107646	1.2727273 score on a scale Standard Deviation 0.7862454	1.4666667 score on a scale Standard Deviation 0.9154754	2.1666667 score on a scale Standard Deviation 1.1690452	1.5625000 score on a scale Standard Deviation 0.7274384	1.5714286 score on a scale Standard Deviation 1.1338934	—	—
Change in Cognitive Function as Measured by Cognitive Failures Questionnaire Do you fail to see what you want in a supermarket (although it's there)?	0.6250000 score on a scale Standard Deviation 0.7696696	0.4545455 score on a scale Standard Deviation 0.5222330	0.9090909 score on a scale Standard Deviation 1.0649879	0.5454545 score on a scale Standard Deviation 0.6875517	1.0666667 score on a scale Standard Deviation 1.0997835	1.0000000 score on a scale Standard Deviation 0.6324555	0.8750000 score on a scale Standard Deviation 0.7187953	0.7142857 score on a scale Standard Deviation 0.4879500	—	—
Change in Cognitive Function as Measured by Cognitive Failures Questionnaire Do you fail to listen to people's names when you are meeting them?	1.7083333 score on a scale Standard Deviation 1.3014763	1.0909091 score on a scale Standard Deviation 1.3003496	1.8181818 score on a scale Standard Deviation 1.0970247	1.0909091 score on a scale Standard Deviation 1.0444659	2.0000000 score on a scale Standard Deviation 1.1952286	1.3333333 score on a scale Standard Deviation 1.0327959	1.6250000 score on a scale Standard Deviation 1.0246951	1.4285714 score on a scale Standard Deviation 1.2724180	—	—
Change in Cognitive Function as Measured by Cognitive Failures Questionnaire Do you say something and realize afterwards that it might be taken as insulting?	1.0000000 score on a scale Standard Deviation 1.0632191	0.9090909 score on a scale Standard Deviation 0.8312094	1.0000000 score on a scale Standard Deviation 1.1126973	0.8181818 score on a scale Standard Deviation 0.6030227	1.0666667 score on a scale Standard Deviation 0.7988086	1.0000000 score on a scale Standard Deviation 0.6324555	1.2500000 score on a scale Standard Deviation 1.0000000	0.8571429 score on a scale Standard Deviation 1.4638501	—	—
Change in Cognitive Function as Measured by Cognitive Failures Questionnaire Do you fail to hear people speaking to you when you are doing something else?	1.3750000 score on a scale Standard Deviation 1.3772215	1.2727273 score on a scale Standard Deviation 1.2720778	1.4090909 score on a scale Standard Deviation 1.0980108	1.0909091 score on a scale Standard Deviation 0.7006490	1.4000000 score on a scale Standard Deviation 0.9102590	1.8333333 score on a scale Standard Deviation 0.9831921	1.4375000 score on a scale Standard Deviation 1.0307764	1.5714286 score on a scale Standard Deviation 0.9759001	—	—
Change in Cognitive Function as Measured by Cognitive Failures Questionnaire Do you lose your temper and regret it?	0.9583333 score on a scale Standard Deviation 1.0417029	1.0000000 score on a scale Standard Deviation 0.7745967	1.0909091 score on a scale Standard Deviation 1.0649879	0.8181818 score on a scale Standard Deviation 0.6030227	0.8666667 score on a scale Standard Deviation 0.8338094	0.8333333 score on a scale Standard Deviation 0.7527727	0.8125000 score on a scale Standard Deviation 0.7500000	1.4285714 score on a scale Standard Deviation 1.2724180	—	—
Change in Cognitive Function as Measured by Cognitive Failures Questionnaire Do you start doing one thing at home and get distracted into doing something else (unintentionally)?	1.2500000 score on a scale Standard Deviation 1.1887151	1.0909091 score on a scale Standard Deviation 1.0444659	1.5454545 score on a scale Standard Deviation 1.1843131	1.0000000 score on a scale Standard Deviation 0.7745967	1.3333333 score on a scale Standard Deviation 1.1126973	2.3333333 score on a scale Standard Deviation 1.2110601	1.3125000 score on a scale Standard Deviation 0.9464847	1.4285714 score on a scale Standard Deviation 1.5118579	—	—
Change in Cognitive Function as Measured by Cognitive Failures Questionnaire Do you find you forget what you came to the shops to buy?	0.8333333 score on a scale Standard Deviation 0.8164966	0.6363636 score on a scale Standard Deviation 0.8090398	1.1363636 score on a scale Standard Deviation 0.9902118	0.3636364 score on a scale Standard Deviation 0.6741999	1.2666667 score on a scale Standard Deviation 1.3345233	1.1666667 score on a scale Standard Deviation 0.9831921	0.7500000 score on a scale Standard Deviation 0.8563488	0.7142857 score on a scale Standard Deviation 0.4879500	—	—
Change in Cognitive Function as Measured by Cognitive Failures Questionnaire Do you drop things?	0.4583333 score on a scale Standard Deviation 0.7790276	0.8181818 score on a scale Standard Deviation 0.6030227	0.8181818 score on a scale Standard Deviation 1.0527227	0.6363636 score on a scale Standard Deviation 0.6741999	0.6666667 score on a scale Standard Deviation 0.6172134	1.3333333 score on a scale Standard Deviation 1.0327956	1.0000000 score on a scale Standard Deviation 0.8944272	0.8571429 score on a scale Standard Deviation 0.6900656	—	—
Change in Cognitive Function as Measured by Cognitive Failures Questionnaire Do you find you can't think of anything to say?	0.7916667 score on a scale Standard Deviation 0.9315329	0.5454545 score on a scale Standard Deviation 0.6875517	0.8636364 score on a scale Standard Deviation 1.1252705	0.9090909 score on a scale Standard Deviation 0.7006490	0.8000000 score on a scale Standard Deviation 0.8618916	1.1666667 score on a scale Standard Deviation 0.7527727	1.0000000 score on a scale Standard Deviation 0.9660918	1.0000000 score on a scale Standard Deviation 1.0000000	—	—
Change in Cognitive Function as Measured by Cognitive Failures Questionnaire Do you bump into people?	0.2500000 score on a scale Standard Deviation 0.5316095	0.1818182 score on a scale Standard Deviation 0.4045199	0.3636364 score on a scale Standard Deviation 0.6579517	0.1818182 score on a scale Standard Deviation 0.6030227	0.4666667 score on a scale Standard Deviation 0.7432234	0.8333333 score on a scale Standard Deviation 1.3291601	0.3125000 score on a scale Standard Deviation 0.4787136	0.5714286 score on a scale Standard Deviation 0.9759001	—	—
Change in Cognitive Function as Measured by Cognitive Failures Questionnaire Do you find you forget whether you've turned off a light or a fire or locked the door?	0.9583333 score on a scale Standard Deviation 0.9990938	0.6363636 score on a scale Standard Deviation 0.6741999	0.8636364 score on a scale Standard Deviation 1.1252705	0.6363636 score on a scale Standard Deviation 0.6741999	1.1333333 score on a scale Standard Deviation 1.0600988	1.3333333 score on a scale Standard Deviation 0.5163978	0.7333333 score on a scale Standard Deviation 0.7037316	1.2857143 score on a scale Standard Deviation 0.9511897	—	—

SECONDARY outcome

Timeframe: Baseline, 12 months, and 24 months

Population: Some participants were not analyzed as the participants did not complete the questionnaires.

-The NDII consists of 10 questions; each with a 5 level ordinally scaled response option ranging from "not at all" to "a lot". The response for each item is then scored from 1 to 5, with 5 denoting higher quality of life (Not at all) and 1 being the least (A lot).

Outcome measures

Measure	Radiotherapy n=23 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	Radiotherapy, Cisplatin n=11 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	1 Month - Radiotherapy n=16 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	1 Month - Radiotherapy + Cisplatin n=7 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	6 Months - Radiotherapy n=17 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	6 Months - Radiotherapy + Cisplatin n=8 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	12 Months - Radiotherapy * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	12 Months - Radiotherapy + Cisplatin * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	24 Months - Radiotherapy * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	24 Months - Radiotherapy + Cisplatin * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways
Change in Quality of Life as Measured by Neck Dissection Impairment Index (NDII) Neck or shoulder pain or discomfort	1.6086957 score on a scale Standard Deviation 1.1175920	2.0909091 score on a scale Standard Deviation 1.2210279	1.4666667 score on a scale Standard Deviation 0.9904304	2.4285714 score on a scale Standard Deviation 1.5118579	1.3125000 score on a scale Standard Deviation 0.8732125	1.7500000 score on a scale Standard Deviation 1.2817399	—	—	—	—
Change in Quality of Life as Measured by Neck Dissection Impairment Index (NDII) Neck or shoulder stiffness	1.4545455 score on a scale Standard Deviation 1.1433981	2.0000000 score on a scale Standard Deviation 1.2649111	1.0000000 score on a scale Standard Deviation 0.8451543	2.4285714 score on a scale Standard Deviation 1.5118579	1.1875000 score on a scale Standard Deviation 1.0468206	1.7500000 score on a scale Standard Deviation 1.3887301	—	—	—	—
Change in Quality of Life as Measured by Neck Dissection Impairment Index (NDII) Difficulty with self-care activities because of neck or shoulder	0.8695652 score on a scale Standard Deviation 0.9197009	1.2727273 score on a scale Standard Deviation 1.1037127	0.3333333 score on a scale Standard Deviation 0.8164966	1.0000000 score on a scale Standard Deviation 1.0000000	0.2500000 score on a scale Standard Deviation 0.5773503	0.5000000 score on a scale Standard Deviation 1.4142136	—	—	—	—
Change in Quality of Life as Measured by Neck Dissection Impairment Index (NDII) Limited ability to life light objects because of your shoulder or neck	0.6521739 score on a scale Standard Deviation 0.8846517	1.6363636 score on a scale Standard Deviation 1.4333686	0.4000000 score on a scale Standard Deviation 0.7367884	0.8571429 score on a scale Standard Deviation 1.0690450	0.2500000 score on a scale Standard Deviation 0.5773503	0.5000000 score on a scale Standard Deviation 0.7559289	—	—	—	—
Change in Quality of Life as Measured by Neck Dissection Impairment Index (NDII) Limited ability to lift heavy objects because of your shoulder or neck	1.6086957 score on a scale Standard Deviation 1.3395769	2.2727273 score on a scale Standard Deviation 1.4206273	0.5333333 score on a scale Standard Deviation 0.9904304	1.5714286 score on a scale Standard Deviation 1.7182494	0.4666667 score on a scale Standard Deviation 0.8338094	0.8750000 score on a scale Standard Deviation 0.9910312	—	—	—	—
Change in Quality of Life as Measured by Neck Dissection Impairment Index (NDII) Limited ability to reach for objects because of your shoulder or neck	1.2173913 score on a scale Standard Deviation 1.3802675	2.0909091 score on a scale Standard Deviation 1.5135749	0.5333333 score on a scale Standard Deviation 0.8338094	1.7142857 score on a scale Standard Deviation 1.6035675	0.5625000 score on a scale Standard Deviation 0.9639329	0.7500000 score on a scale Standard Deviation 1.0350983	—	—	—	—
Change in Quality of Life as Measured by Neck Dissection Impairment Index (NDII) Overall activity level because of your shoulder or neck	1.0000000 score on a scale Standard Deviation 1.2431631	1.9090909 score on a scale Standard Deviation 1.5782614	0.5333333 score on a scale Standard Deviation 0.8338094	1.5714286 score on a scale Standard Deviation 1.5118579	0.3750000 score on a scale Standard Deviation 0.6191392	0.6250000 score on a scale Standard Deviation 0.7440238	—	—	—	—
Change in Quality of Life as Measured by Neck Dissection Impairment Index (NDII) Has the treatment of your neck affected your participation in social activities?	0.7391304 score on a scale Standard Deviation 1.1368774	0.9090909 score on a scale Standard Deviation 1.2210279	0.0666667 score on a scale Standard Deviation 0.2581989	0.8571429 score on a scale Standard Deviation 0.8997354	0.1875000 score on a scale Standard Deviation 0.4031129	0.5000000 score on a scale Standard Deviation 1.0690450	—	—	—	—
Change in Quality of Life as Measured by Neck Dissection Impairment Index (NDII) Limited in ability to do leisure or recreational activities because of your neck or shoulder?	1.0869565 score on a scale Standard Deviation 1.3788349	1.7272727 score on a scale Standard Deviation 1.4893562	0.2000000 score on a scale Standard Deviation 0.5606119	1.4285714 score on a scale Standard Deviation 1.2724180	0.2500000 score on a scale Standard Deviation 0.4472136	0.7500000 score on a scale Standard Deviation 1.1649647	—	—	—	—
Change in Quality of Life as Measured by Neck Dissection Impairment Index (NDII) Limited in ability to do work including work at home because of neck or shoulder discomfort or pain?	1.1304348 score on a scale Standard Deviation 1.3916749	1.7272727 score on a scale Standard Deviation 1.6180797	0.2666667 score on a scale Standard Deviation 0.5936168	1.2857143 score on a scale Standard Deviation 1.1126973	0.1250000 score on a scale Standard Deviation 0.3415650	0.5000000 score on a scale Standard Deviation 1.0690450	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 1 month, 6 months, 12 months, and 24 months

Population: Some participants were not analyzed as the participants did not complete the questionnaires.

• It contains 8 questions regarding dryness either during feeding or in the unstimulated state. Participants rate each item from 0 to 10, where 10 indicates the maximum dryness or discomfort due to dryness.
• The higher the score the worse the participant's xerostomia

Outcome measures

Measure	Radiotherapy n=24 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	Radiotherapy, Cisplatin n=11 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	1 Month - Radiotherapy n=21 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	1 Month - Radiotherapy + Cisplatin n=11 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	6 Months - Radiotherapy n=14 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	6 Months - Radiotherapy + Cisplatin n=7 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	12 Months - Radiotherapy n=17 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	12 Months - Radiotherapy + Cisplatin n=7 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	24 Months - Radiotherapy n=17 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	24 Months - Radiotherapy + Cisplatin n=8 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways
Change in Quality of Life as Measured by University of Michigan Xerostomia Questionnaire Rate your difficulty chewing due to dryness	2.3913043 score on a scale Standard Deviation 2.2711457	1.4545455 score on a scale Standard Deviation 2.5831623	3.5238095 score on a scale Standard Deviation 2.6947922	3.1818182 score on a scale Standard Deviation 2.8219916	3.0714286 score on a scale Standard Deviation 2.4326082	4.5714286 score on a scale Standard Deviation 3.5523299	2.6250000 score on a scale Standard Deviation 2.2766935	3.7142857 score on a scale Standard Deviation 3.8606686	3.6250000 score on a scale Standard Deviation 2.9183329	2.7500000 score on a scale Standard Deviation 2.6592158
Change in Quality of Life as Measured by University of Michigan Xerostomia Questionnaire Rate your difficulty in swallowing solid food due to dryness	2.6956522 score on a scale Standard Deviation 2.6532104	1.6363636 score on a scale Standard Deviation 2.8380531	3.4285714 score on a scale Standard Deviation 2.5994505	3.9000000 score on a scale Standard Deviation 2.9608557	3.5000000 score on a scale Standard Deviation 2.9807072	5.2857143 score on a scale Standard Deviation 3.5456210	3.3750000 score on a scale Standard Deviation 3.0304015	4.1428571 score on a scale Standard Deviation 3.5321651	4.1250000 score on a scale Standard Deviation 2.8722813	3.2500000 score on a scale Standard Deviation 3.0118812
Change in Quality of Life as Measured by University of Michigan Xerostomia Questionnaire Rate the frequency of your sleeping problems due to dryness	1.7916667 score on a scale Standard Deviation 1.8876985	1.5454545 score on a scale Standard Deviation 2.8412545	3.2857143 score on a scale Standard Deviation 2.9179249	3.0000000 score on a scale Standard Deviation 2.8982753	1.7142857 score on a scale Standard Deviation 2.0542104	4.4285714 score on a scale Standard Deviation 2.8199966	2.2500000 score on a scale Standard Deviation 2.2656861	3.5714286 score on a scale Standard Deviation 3.1014590	2.6000000 score on a scale Standard Deviation 2.8485585	2.7500000 score on a scale Standard Deviation 2.4348658
Change in Quality of Life as Measured by University of Michigan Xerostomia Questionnaire Rate your difficulty in talking due to dryness	2.3333333 score on a scale Standard Deviation 2.4788964	1.3636364 score on a scale Standard Deviation 2.2033033	2.8095238 score on a scale Standard Deviation 2.9089353	3.9090909 score on a scale Standard Deviation 2.3855626	3.0000000 score on a scale Standard Deviation 2.9612887	4.8571429 score on a scale Standard Deviation 3.2366944	2.5625000 score on a scale Standard Deviation 2.8276905	3.5714286 score on a scale Standard Deviation 3.2071349	3.6875000 score on a scale Standard Deviation 2.9825884	3.1250000 score on a scale Standard Deviation 2.7998724
Change in Quality of Life as Measured by University of Michigan Xerostomia Questionnaire Rate your mouth or throat dryness when eating food	2.2173913 score on a scale Standard Deviation 2.1523037	1.8181818 score on a scale Standard Deviation 3.0271499	3.8571429 score on a scale Standard Deviation 2.9203718	3.7272727 score on a scale Standard Deviation 3.2277208	3.5000000 score on a scale Standard Deviation 2.8216198	5.7142857 score on a scale Standard Deviation 3.0394235	3.5000000 score on a scale Standard Deviation 3.0767949	4.0000000 score on a scale Standard Deviation 3.6968455	3.8750000 score on a scale Standard Deviation 3.0523215	3.3750000 score on a scale Standard Deviation 3.0207615
Change in Quality of Life as Measured by University of Michigan Xerostomia Questionnaire Rate your mouth or throat dryness while not eating	2.1250000 score on a scale Standard Deviation 2.1931217	1.5454545 score on a scale Standard Deviation 2.3393861	3.8571429 score on a scale Standard Deviation 2.7979584	3.0909091 score on a scale Standard Deviation 2.1191765	2.6428571 score on a scale Standard Deviation 2.8177226	4.7142857 score on a scale Standard Deviation 2.4976179	3.2500000 score on a scale Standard Deviation 2.7446918	3.4285714 score on a scale Standard Deviation 3.4572216	3.7500000 score on a scale Standard Deviation 3.1517191	2.6250000 score on a scale Standard Deviation 2.7222627
Change in Quality of Life as Measured by University of Michigan Xerostomia Questionnaire Rate the frequency of sipping liquids to aid swallowing food	3.1739130 score on a scale Standard Deviation 2.7741039	2.2727273 score on a scale Standard Deviation 3.1013194	5.1428571 score on a scale Standard Deviation 3.2293299	4.0000000 score on a scale Standard Deviation 3.4351128	5.0000000 score on a scale Standard Deviation 2.6602487	6.7142857 score on a scale Standard Deviation 2.6903708	5.0625000 score on a scale Standard Deviation 3.5864328	5.0000000 score on a scale Standard Deviation 3.6968455	5.3125000 score on a scale Standard Deviation 3.2397274	4.1250000 score on a scale Standard Deviation 3.6815175
Change in Quality of Life as Measured by University of Michigan Xerostomia Questionnaire Rate the frequency of sipping liquids for oral comfort when not eating	2.9565217 score on a scale Standard Deviation 2.7216015	2.0909091 score on a scale Standard Deviation 2.8090762	4.6190476 score on a scale Standard Deviation 3.3388050	3.3636364 score on a scale Standard Deviation 2.9076701	3.4285714 score on a scale Standard Deviation 3.1553199	5.2857143 score on a scale Standard Deviation 2.7516229	3.8750000 score on a scale Standard Deviation 3.4229617	3.7142857 score on a scale Standard Deviation 3.7733401	4.0000000 score on a scale Standard Deviation 3.4448028	2.7500000 score on a scale Standard Deviation 3.3273756

SECONDARY outcome

Timeframe: Baseline, 1 month, and 12 months

Population: Some participants were not analyzed as the participants did not complete the questionnaires.

• 11 item questionnaire to identify issues with hearing
• Answers are yes = 4, sometimes = 2, and no = 0
• The higher the score the more issues the participant has with hearing

Outcome measures

Measure	Radiotherapy n=24 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	Radiotherapy, Cisplatin n=11 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	1 Month - Radiotherapy n=22 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	1 Month - Radiotherapy + Cisplatin n=11 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	6 Months - Radiotherapy n=16 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	6 Months - Radiotherapy + Cisplatin n=7 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	12 Months - Radiotherapy * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	12 Months - Radiotherapy + Cisplatin * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	24 Months - Radiotherapy * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	24 Months - Radiotherapy + Cisplatin * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways
Change in Hearing as Measured by Hearing Handicap Inventory - Adult Does a hearing problem cause you to feel embarrassed when you meet new people?	0.2500000 score on a scale Standard Deviation 0.6079188	0.5454545 score on a scale Standard Deviation 0.9341987	0.2380952 score on a scale Standard Deviation 0.6248809	0.1818182 score on a scale Standard Deviation 0.6030227	0.1333333 score on a scale Standard Deviation 0.3518658	1.0000000 score on a scale Standard Deviation 1.0000000	—	—	—	—
Change in Hearing as Measured by Hearing Handicap Inventory - Adult Does a hearing problem cause you to feel frustrated when talking to members of your family?	0.1250000 score on a scale Standard Deviation 0.4484272	0.1818182 score on a scale Standard Deviation 0.6030227	0.5238095 score on a scale Standard Deviation 0.8728716	0.3636364 score on a scale Standard Deviation 0.8090398	0.1333333 score on a scale Standard Deviation 0.3518658	0.7142857 score on a scale Standard Deviation 0.9511897	—	—	—	—
Change in Hearing as Measured by Hearing Handicap Inventory - Adult Do you have difficulty hearing or understanding co-workers or clients or customers?	0.5000000 score on a scale Standard Deviation 0.8340577	1.0909091 score on a scale Standard Deviation 1.0444659	0.6666667 score on a scale Standard Deviation 0.9128709	1.0909091 score on a scale Standard Deviation 1.0444659	0.1333333 score on a scale Standard Deviation 0.3518658	1.7142857 score on a scale Standard Deviation 0.4879500	—	—	—	—
Change in Hearing as Measured by Hearing Handicap Inventory - Adult Do you feel that any difficulty with your hearing limits or hampers your personal or social life?	0.1666667 score on a scale Standard Deviation 0.4815434	0.6363636 score on a scale Standard Deviation 0.9244163	0.3809524 score on a scale Standard Deviation 0.7400129	0.7272727 score on a scale Standard Deviation 1.0090500	0.2000000 score on a scale Standard Deviation 0.5606119	0.7142857 score on a scale Standard Deviation 0.9511897	—	—	—	—
Change in Hearing as Measured by Hearing Handicap Inventory - Adult Do you feel handicapped by a hearing problem?	0.1250000 score on a scale Standard Deviation 0.4484272	0.5454545 score on a scale Standard Deviation 0.9341987	0.1428571 score on a scale Standard Deviation 0.4780914	0.3636364 score on a scale Standard Deviation 0.8090398	0.0666667 score on a scale Standard Deviation 0.2581989	0.7142857 score on a scale Standard Deviation 0.9511897	—	—	—	—
Change in Hearing as Measured by Hearing Handicap Inventory - Adult Does a hearing problem cause you difficulty in the movies or in the theater?	0.1666667 score on a scale Standard Deviation 0.4815434	0.4545455 score on a scale Standard Deviation 0.8201995	0.5238095 score on a scale Standard Deviation 0.8728716	0.2727273 score on a scale Standard Deviation 0.6466698	0.1333333 score on a scale Standard Deviation 0.5163978	0.4285714 score on a scale Standard Deviation 0.7867958	—	—	—	—
Change in Hearing as Measured by Hearing Handicap Inventory - Adult Does a hearing problem cause you difficulty when in a restaurant with relatives or friends?	0.2173913 score on a scale Standard Deviation 0.5997364	0.7272727 score on a scale Standard Deviation 0.9045340	0.6190476 score on a scale Standard Deviation 0.8646497	0.8181818 score on a scale Standard Deviation 0.9816498	0.2666667 score on a scale Standard Deviation 0.5936168	1.5714286 score on a scale Standard Deviation 0.7867958	—	—	—	—
Change in Hearing as Measured by Hearing Handicap Inventory - Adult Does a hearing problem cause you to attend religious services less often than you would like?	0.0416667 score on a scale Standard Deviation 0.2041241	0.1818182 score on a scale Standard Deviation 0.6030227	0.0000000 score on a scale Standard Deviation 0.0000000	0.0000000 score on a scale Standard Deviation 0.0000000	0.0000000 score on a scale Standard Deviation 0.0000000	0.0000000 score on a scale Standard Deviation 0.0000000	—	—	—	—
Change in Hearing as Measured by Hearing Handicap Inventory - Adult Does a hearing problem cause you to have argments with family members?	0.2500000 score on a scale Standard Deviation 0.6756639	0.1818182 score on a scale Standard Deviation 0.6030227	0.1000000 score on a scale Standard Deviation 0.4472136	0.1818182 score on a scale Standard Deviation 0.6030227	0.2666667 score on a scale Standard Deviation 0.7037316	0.1428571 score on a scale Standard Deviation 0.3779645	—	—	—	—
Change in Hearing as Measured by Hearing Handicap Inventory - Adult Does a hearing problem cause you difficulty when listening to TV or radio?	0.3750000 score on a scale Standard Deviation 0.7109364	0.4545455 score on a scale Standard Deviation 0.8201995	0.8571429 score on a scale Standard Deviation 0.9636241	0.4545455 score on a scale Standard Deviation 0.8201995	0.4000000 score on a scale Standard Deviation 0.7367884	0.7142857 score on a scale Standard Deviation 0.9511897	—	—	—	—
Change in Hearing as Measured by Hearing Handicap Inventory - Adult Does a hearing problem cause you difficulty when visiting friends or relatives or neighbors?	0.3333333 score on a scale Standard Deviation 0.7019641	0.6363636 score on a scale Standard Deviation 0.9244163	0.1904762 score on a scale Standard Deviation 0.5117663	0.4545455 score on a scale Standard Deviation 0.8201995	0.1333333 score on a scale Standard Deviation 0.3518658	0.7142857 score on a scale Standard Deviation 0.9511897	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 1 month, 6 months, and 12 months

Population: Some participants were not analyzed as the participants did not complete the questionnaires.

• 1 question that asks about taste acuity
• Answers are 0 = same taste acuity as before treatment; 1 = mild loss of taste acuity, but not inconvenient in daily life; moderate loss of taste acuity, and sometimes inconvenient in daily life; severe loss of taste acuity, and frequently inconvenient in daily life; and 4 = almost complete or complete loss of taste acuity
• The higher the score the worse the participant's taste acuity

Outcome measures

Measure	Radiotherapy n=24 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	Radiotherapy, Cisplatin n=11 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	1 Month - Radiotherapy n=22 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	1 Month - Radiotherapy + Cisplatin n=11 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	6 Months - Radiotherapy n=14 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	6 Months - Radiotherapy + Cisplatin n=7 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	12 Months - Radiotherapy n=16 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	12 Months - Radiotherapy + Cisplatin n=7 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	24 Months - Radiotherapy * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	24 Months - Radiotherapy + Cisplatin * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways
Change in Quality of Life as Measured by Scale of Subjective Total Taste Acuity	1.0833333 score on a scale Standard Deviation 1.1000659	0.9090909 score on a scale Standard Deviation 0.8312094	2.1363636 score on a scale Standard Deviation 1.0821255	2.9090909 score on a scale Standard Deviation 1.0444659	0.9285714 score on a scale Standard Deviation 0.7300459	2.4285714 score on a scale Standard Deviation 0.9759001	1.0000000 score on a scale Standard Deviation 0.7559289	1.5714286 score on a scale Standard Deviation 0.7867958	—	—

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: Some participants were not analyzed as the participants did not complete the questionnaires.

• 31 questions regarding participant's speech and the effects of speech on his/her life
• The answers for the first 30 questions range from 0 = never to 4 = always and the answers for the 31st question ranges from 0 = excellent to bad = 4
• The higher the score the worse the participant's speech is affecting his/her life

Outcome measures

Measure	Radiotherapy n=24 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	Radiotherapy, Cisplatin n=11 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	1 Month - Radiotherapy n=16 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	1 Month - Radiotherapy + Cisplatin n=7 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	6 Months - Radiotherapy * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	6 Months - Radiotherapy + Cisplatin * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	12 Months - Radiotherapy * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	12 Months - Radiotherapy + Cisplatin * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	24 Months - Radiotherapy * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	24 Months - Radiotherapy + Cisplatin * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways
Change in Quality of Life as Measured by Speech Handicap Index My speech makes it difficult for people to understand me	1.9565217 score on a scale Standard Deviation 1.0215078	1.7272727 score on a scale Standard Deviation 0.9045340	1.3333333 score on a scale Standard Deviation 0.6172134	1.8333333 score on a scale Standard Deviation 1.3291601	—	—	—	—	—	—
Change in Quality of Life as Measured by Speech Handicap Index My speech makes me feel incompetent	1.3750000 score on a scale Standard Deviation 0.6468990	1.2727273 score on a scale Standard Deviation 0.6466698	1.1333333 score on a scale Standard Deviation 0.3518658	1.5000000 score on a scale Standard Deviation 0.8366600	—	—	—	—	—	—
Change in Quality of Life as Measured by Speech Handicap Index People ask me to repeat myself when speaking face-to-face	1.5416667 score on a scale Standard Deviation 0.7790276	1.7272727 score on a scale Standard Deviation 0.9045340	1.3333333 score on a scale Standard Deviation 0.4879500	1.8333333 score on a scale Standard Deviation 0.9831921	—	—	—	—	—	—
Change in Quality of Life as Measured by Speech Handicap Index My speech problem upsets me	1.2083333 score on a scale Standard Deviation 0.4148511	1.5454545 score on a scale Standard Deviation 0.8201995	1.2666667 score on a scale Standard Deviation 0.4577377	1.8571429 score on a scale Standard Deviation 1.0690450	—	—	—	—	—	—
Change in Quality of Life as Measured by Speech Handicap Index I am less outgoing because of my speech problem	1.2500000 score on a scale Standard Deviation 0.5316095	1.4545455 score on a scale Standard Deviation 0.6875517	1.0666667 score on a scale Standard Deviation 0.2581989	1.4285714 score on a scale Standard Deviation 0.7867958	—	—	—	—	—	—
Change in Quality of Life as Measured by Speech Handicap Index I run out of air when I speak	1.5000000 score on a scale Standard Deviation 0.7223151	1.4545455 score on a scale Standard Deviation 0.6875517	1.2666667 score on a scale Standard Deviation 0.7037316	1.8333333 score on a scale Standard Deviation 1.3291601	—	—	—	—	—	—
Change in Quality of Life as Measured by Speech Handicap Index The intelligibility of my speech varies throughout the day	2.0000000 score on a scale Standard Deviation 1.0632191	1.5454545 score on a scale Standard Deviation 0.8201995	1.4000000 score on a scale Standard Deviation 0.7367884	1.8333333 score on a scale Standard Deviation 1.3291601	—	—	—	—	—	—
Change in Quality of Life as Measured by Speech Handicap Index People ask me why I'm hard to understand	1.2916667 score on a scale Standard Deviation 0.6240935	1.1818182 score on a scale Standard Deviation 0.4045199	1.1333333 score on a scale Standard Deviation 0.3518658	1.3333333 score on a scale Standard Deviation 0.5163978	—	—	—	—	—	—
Change in Quality of Life as Measured by Speech Handicap Index I feel annoyed when people ask me to repeat	1.3750000 score on a scale Standard Deviation 0.8242256	1.2727273 score on a scale Standard Deviation 0.6466698	1.3333333 score on a scale Standard Deviation 0.4879500	1.6666667 score on a scale Standard Deviation 1.0327956	—	—	—	—	—	—
Change in Quality of Life as Measured by Speech Handicap Index I avoid using the phone	1.6250000 score on a scale Standard Deviation 1.2091139	1.5454545 score on a scale Standard Deviation 0.9341987	1.1333333 score on a scale Standard Deviation 0.3518658	1.6666667 score on a scale Standard Deviation 1.0327956	—	—	—	—	—	—
Change in Quality of Life as Measured by Speech Handicap Index I'm tense when talking to others because of my speech	1.4166667 score on a scale Standard Deviation 0.7172815	1.5454545 score on a scale Standard Deviation 0.8201995	1.0666667 score on a scale Standard Deviation 0.2581989	1.6666667 score on a scale Standard Deviation 1.0327956	—	—	—	—	—	—
Change in Quality of Life as Measured by Speech Handicap Index My articulation is unclear	1.8333333 score on a scale Standard Deviation 0.9630868	1.8181818 score on a scale Standard Deviation 1.3506205	1.4666667 score on a scale Standard Deviation 0.7432234	1.8333333 score on a scale Standard Deviation 1.3291601	—	—	—	—	—	—
Change in Quality of Life as Measured by Speech Handicap Index People have difficulty understanding me in a noisy room	1.8750000 score on a scale Standard Deviation 1.0347232	1.8181818 score on a scale Standard Deviation 0.9816498	1.6000000 score on a scale Standard Deviation 0.9856108	1.8333333 score on a scale Standard Deviation 0.9831921	—	—	—	—	—	—
Change in Quality of Life as Measured by Speech Handicap Index I tend to avoid groups of people because of my speech	1.2500000 score on a scale Standard Deviation 0.6079188	1.727277 score on a scale Standard Deviation 0.9045340	1.2666667 score on a scale Standard Deviation 0.7988086	1.8333333 score on a scale Standard Deviation 1.3291601	—	—	—	—	—	—
Change in Quality of Life as Measured by Speech Handicap Index People seem irritated with my speech	1.1250000 score on a scale Standard Deviation 0.3378320	1.3636364 score on a scale Standard Deviation 0.5045250	1.1333333 score on a scale Standard Deviation 0.3518658	1.5000000 score on a scale Standard Deviation 0.8366600	—	—	—	—	—	—
Change in Quality of Life as Measured by Speech Handicap Index I speak with friends and neighbors and relatives less often because of my speech	1.4166667 score on a scale Standard Deviation 0.7172815	1.2727273 score on a scale Standard Deviation 0.6466698	1.2666667 score on a scale Standard Deviation 0.7988086	1.5000000 score on a scale Standard Deviation 0.8366600	—	—	—	—	—	—
Change in Quality of Life as Measured by Speech Handicap Index I feel ask though I have to strain to speak	1.833333 score on a scale Standard Deviation 0.9630868	1.9090909 score on a scale Standard Deviation 1.1361818	1.2000000 score on a scale Standard Deviation 0.5606119	2.0000000 score on a scale Standard Deviation 1.2649111	—	—	—	—	—	—
Change in Quality of Life as Measured by Speech Handicap Index I find other people don't understand my speaking problem	1.1666667 score on a scale Standard Deviation 0.3806935	1.2727273 score on a scale Standard Deviation 0.6466698	1.0666667 score on a scale Standard Deviation 0.2581989	1.3333333 score on a scale Standard Deviation 0.5163978	—	—	—	—	—	—
Change in Quality of Life as Measured by Speech Handicap Index My speaking difficulties restrict my person and social life	1.3750000 score on a scale Standard Deviation 0.6468990	1.2727273 score on a scale Standard Deviation 0.6466698	1.2000000 score on a scale Standard Deviation 0.5606119	1.5000000 score on a scale Standard Deviation 0.8366600	—	—	—	—	—	—
Change in Quality of Life as Measured by Speech Handicap Index The intelligibility is unpredictable	1.5833333 score on a scale Standard Deviation 0.8805466	1.3636364 score on a scale Standard Deviation 0.8090398	1.1333333 score on a scale Standard Deviation 0.3518658	1.5000000 score on a scale Standard Deviation 0.8366600	—	—	—	—	—	—
Change in Quality of Life as Measured by Speech Handicap Index I feel left out of conversations because of my speech	1.2083333 score on a scale Standard Deviation 0.4148511	1.3636364 score on a scale Standard Deviation 0.6741999	1.3333333 score on a scale Standard Deviation 0.8164966	1.4285714 score on a scale Standard Deviation 0.7867958	—	—	—	—	—	—
Change in Quality of Life as Measured by Speech Handicap Index I use a great deal of effort to speak	1.8750000 score on a scale Standard Deviation 0.9469631	1.6363636 score on a scale Standard Deviation 0.9244163	1.2666667 score on a scale Standard Deviation 0.4577377	1.8571429 score on a scale Standard Deviation 1.0690450	—	—	—	—	—	—
Change in Quality of Life as Measured by Speech Handicap Index My speech is worse in the evening	1.6250000 score on a scale Standard Deviation 0.8753881	1.6363636 score on a scale Standard Deviation 0.9244163	1.3333333 score on a scale Standard Deviation 0.7237469	1.8571429 score on a scale Standard Deviation 0.8997354	—	—	—	—	—	—
Change in Quality of Life as Measured by Speech Handicap Index My speech problem causes me to lose income	1.2916667 score on a scale Standard Deviation 0.6902531	1.8181818 score on a scale Standard Deviation 1.2504545	1.0000000 score on a scale Standard Deviation 0.0000000	1.4285714 score on a scale Standard Deviation 0.7867958	—	—	—	—	—	—
Change in Quality of Life as Measured by Speech Handicap Index I try to change my speech to sound different	1.2916667 score on a scale Standard Deviation 0.8064504	1.0909091 score on a scale Standard Deviation 0.3015113	1.0666667 score on a scale Standard Deviation 0.2581989	1.2857143 score on a scale Standard Deviation 0.7559289	—	—	—	—	—	—
Change in Quality of Life as Measured by Speech Handicap Index My family has difficulty understanding me when I call them throughout the house	1.5000000 score on a scale Standard Deviation 0.7801895	1.6363636 score on a scale Standard Deviation 0.8090398	1.1333333 score on a scale Standard Deviation 0.5163978	1.5714286 score on a scale Standard Deviation 0.9759001	—	—	—	—	—	—
Change in Quality of Life as Measured by Speech Handicap Index My speech makes me feel handicapped	1.3333333 score on a scale Standard Deviation 0.7019641	1.4545455 score on a scale Standard Deviation 0.6875517	1.0666667 score on a scale Standard Deviation 0.2581989	1.5714286 score on a scale Standard Deviation 0.9759001	—	—	—	—	—	—
Change in Quality of Life as Measured by Speech Handicap Index I have difficulties to continue a conversation because of my speech	1.5000000 score on a scale Standard Deviation 0.7801895	1.5454545 score on a scale Standard Deviation 0.8201995	1.1333333 score on a scale Standard Deviation 0.3518658	1.8571429 score on a scale Standard Deviation 1.0690450	—	—	—	—	—	—
Change in Quality of Life as Measured by Speech Handicap Index I feel embarrassed when people ask me to repeat	1.2083333 score on a scale Standard Deviation 0.5089774	1.3636364 score on a scale Standard Deviation 0.9244163	1.0000000 score on a scale Standard Deviation 0.0000000	1.2857143 score on a scale Standard Deviation 0.4879500	—	—	—	—	—	—
Change in Quality of Life as Measured by Speech Handicap Index I'm ashamed of my speech problem	1.0833333 score on a scale Standard Deviation 0.2823299	1.2727273 score on a scale Standard Deviation 0.9045340	1.0000000 score on a scale Standard Deviation 0.0000000	1.2857143 score on a scale Standard Deviation 0.4879500	—	—	—	—	—	—
Change in Quality of Life as Measured by Speech Handicap Index How do you rate your own speech at this moment?	2.1304348 score on a scale Standard Deviation 0.9678631	1.4545455 score on a scale Standard Deviation 0.5222330	1.3846154 score on a scale Standard Deviation 0.6504436	1.5714286 score on a scale Standard Deviation 0.7867958	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 1 month, 6 months, 12 months, and 24 months

Population: Some participants were not analyzed as the participants did not complete the questionnaires.

• 30 questions designed to assess the quality of life of cancer patients
• The first 28 questions have answers that range from 1=not at all to 4 = very much. The higher score indicates a worse quality of life
• The last 2 questions have answers that range from 1 = very poor to 7 = excellent. The higher score indicates a better quality of life

Outcome measures

Measure	Radiotherapy n=24 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	Radiotherapy, Cisplatin n=11 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	1 Month - Radiotherapy n=22 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	1 Month - Radiotherapy + Cisplatin n=11 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	6 Months - Radiotherapy n=14 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	6 Months - Radiotherapy + Cisplatin n=7 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	12 Months - Radiotherapy n=16 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	12 Months - Radiotherapy + Cisplatin n=7 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	24 Months - Radiotherapy n=17 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	24 Months - Radiotherapy + Cisplatin n=8 Participants * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways
Change in Quality of Life as Measured by EORTC QLQ-C30 Do you need help with eating, dressing, washing yourself or using the toilet?	1.0833333 score on a scale Standard Deviation 0.2823299	1.0909091 score on a scale Standard Deviation 0.3015113	1.0909091 score on a scale Standard Deviation 0.4264014	1.0000000 score on a scale Standard Deviation 0.0000000	1.0714286 score on a scale Standard Deviation 0.2672612	1.1428571 score on a scale Standard Deviation 0.3779645	1.0000000 score on a scale Standard Deviation 0.0000000	1.2857143 score on a scale Standard Deviation 0.4879500	1.0000000 score on a scale Standard Deviation 0.0000000	1.0000000 score on a scale Standard Deviation 0.0000000
Change in Quality of Life as Measured by EORTC QLQ-C30 Were you limited in doing either your work or other daily activities?	2.0833333 score on a scale Standard Deviation 1.0179548	1.6363636 score on a scale Standard Deviation 1.0269106	1.4090909 score on a scale Standard Deviation 0.7341397	1.2727273 score on a scale Standard Deviation 0.6466698	1.4285714 score on a scale Standard Deviation 0.6462062	1.1428571 score on a scale Standard Deviation 0.3779645	1.2000000 score on a scale Standard Deviation 0.5606119	1.2857143 score on a scale Standard Deviation 0.4879500	1.3750000 score on a scale Standard Deviation 0.8062258	1.0000000 score on a scale Standard Deviation 0.0000000
Change in Quality of Life as Measured by EORTC QLQ-C30 Were you short of breath?	1.2916667 score on a scale Standard Deviation 0.6240935	1.0000000 score on a scale Standard Deviation 0.0000000	1.1363636 score on a scale Standard Deviation 0.3512501	1.3636364 score on a scale Standard Deviation 0.5045250	1.1428571 score on a scale Standard Deviation 0.3631365	1.4285714 score on a scale Standard Deviation 0.7867958	1.2666667 score on a scale Standard Deviation 0.5936168	1.4285714 score on a scale Standard Deviation 0.7867958	1.1875000 score on a scale Standard Deviation 0.5439056	1.3750000 score on a scale Standard Deviation 0.5175492
Change in Quality of Life as Measured by EORTC QLQ-C30 Have you had pain?	2.0000000 score on a scale Standard Deviation 0.7801895	1.7272727 score on a scale Standard Deviation 0.7862454	1.5000000 score on a scale Standard Deviation 0.5976143	1.7272727 score on a scale Standard Deviation 0.9045340	1.7142857 score on a scale Standard Deviation 0.8254203	1.8571429 score on a scale Standard Deviation 0.8997354	1.6000000 score on a scale Standard Deviation 0.7367884	1.8571429 score on a scale Standard Deviation 0.8997354	1.6875000 score on a scale Standard Deviation 0.7932003	2.0000000 score on a scale Standard Deviation 0.7559289
Change in Quality of Life as Measured by EORTC QLQ-C30 Did you need to rest?	1.9166667 score on a scale Standard Deviation 0.8805466	1.5454545 score on a scale Standard Deviation 0.5222330	1.5909091 score on a scale Standard Deviation 0.7341397	1.6363636 score on a scale Standard Deviation 0.6741999	1.5000000 score on a scale Standard Deviation 0.7595545	1.7142857 score on a scale Standard Deviation 0.7559289	1.6000000 score on a scale Standard Deviation 0.7367884	1.8571429 score on a scale Standard Deviation 0.6900656	1.6875000 score on a scale Standard Deviation 0.7041543	1.6250000 score on a scale Standard Deviation 0.7440238
Change in Quality of Life as Measured by EORTC QLQ-C30 Have you had trouble sleeping?	1.8333333 score on a scale Standard Deviation 0.8681147	2.2727273 score on a scale Standard Deviation 1.1908744	1.5454545 score on a scale Standard Deviation 0.6709817	1.6363636 score on a scale Standard Deviation 0.6741999	1.3571429 score on a scale Standard Deviation 0.6333237	2.4285714 score on a scale Standard Deviation 0.9759001	1.9333333 score on a scale Standard Deviation 0.9611501	2.0000000 score on a scale Standard Deviation 0.8164966	1.3750000 score on a scale Standard Deviation 0.6191392	2.1250000 score on a scale Standard Deviation 0.6408699
Change in Quality of Life as Measured by EORTC QLQ-C30 Have you felt weak?	1.9166667 score on a scale Standard Deviation 0.9743076	1.8181818 score on a scale Standard Deviation 0.7507572	1.6818182 score on a scale Standard Deviation 0.8387271	1.4545455 score on a scale Standard Deviation 0.5222330	1.5384615 score on a scale Standard Deviation 0.8770580	1.4285714 score on a scale Standard Deviation 0.7867958	1.3333333 score on a scale Standard Deviation 0.6172134	1.5714286 score on a scale Standard Deviation 0.7867958	1.5625000 score on a scale Standard Deviation 0.7274384	1.3750000 score on a scale Standard Deviation 0.5175492
Change in Quality of Life as Measured by EORTC QLQ-C30 Have you lacked appetite?	1.6956522 score on a scale Standard Deviation 0.8756703	1.6363636 score on a scale Standard Deviation 0.9244163	1.6363636 score on a scale Standard Deviation 0.7267314	1.3636364 score on a scale Standard Deviation 0.5045250	1.3571429 score on a scale Standard Deviation 0.6333237	1.2857143 score on a scale Standard Deviation 0.4879500	1.2000000 score on a scale Standard Deviation 0.5606119	1.2857143 score on a scale Standard Deviation 0.7559289	1.5000000 score on a scale Standard Deviation 0.8944272	1.1250000 score on a scale Standard Deviation 0.3535534
Change in Quality of Life as Measured by EORTC QLQ-C30 Have you felt nauseated?	1.1666667 score on a scale Standard Deviation 0.6370221	1.3636364 score on a scale Standard Deviation 0.5045250	1.1818182 score on a scale Standard Deviation 0.5010811	1.1818182 score on a scale Standard Deviation 0.4045199	1.2142857 score on a scale Standard Deviation 0.4258153	1.1428571 score on a scale Standard Deviation 0.3779645	1.1333333 score on a scale Standard Deviation 0.5163978	1.0000000 score on a scale Standard Deviation 0.0000000	1.1875000 score on a scale Standard Deviation 0.4031129	1.0000000 score on a scale Standard Deviation 0.0000000
Change in Quality of Life as Measured by EORTC QLQ-C30 Have you vomited?	1.0833333 score on a scale Standard Deviation 0.4082483	1.0000000 score on a scale Standard Deviation 0.0000000	1.0454545 score on a scale Standard Deviation 0.2132007	1.0000000 score on a scale Standard Deviation 0.0000000	1.0714286 score on a scale Standard Deviation 0.2672612	1.0000000 score on a scale Standard Deviation 0.0000000	1.0000000 score on a scale Standard Deviation 0.0000000	1.0000000 score on a scale Standard Deviation 0.0000000	1.0000000 score on a scale Standard Deviation 0.0000000	1.0000000 score on a scale Standard Deviation 0.0000000
Change in Quality of Life as Measured by EORTC QLQ-C30 Have you had diarrhea?	1.0416667 score on a scale Standard Deviation 0.2041241	1.1818182 score on a scale Standard Deviation 0.4045199	1.1363636 score on a scale Standard Deviation 0.3512501	1.0000000 score on a scale Standard Deviation 0.0000000	1.1428571 score on a scale Standard Deviation 0.3631365	1.1428571 score on a scale Standard Deviation 0.3779645	1.2000000 score on a scale Standard Deviation 0.4140393	1.1428571 score on a scale Standard Deviation 0.3779645	1.0666667 score on a scale Standard Deviation 0.2581989	1.1250000 score on a scale Standard Deviation 0.3535534
Change in Quality of Life as Measured by EORTC QLQ-C30 Were you tired?	2.0000000 score on a scale Standard Deviation 0.8846517	2.0000000 score on a scale Standard Deviation 0.7745967	1.181818 score on a scale Standard Deviation 0.7950061	1.7272727 score on a scale Standard Deviation 0.6466698	1.6428571 score on a scale Standard Deviation 0.8418974	1.8571429 score on a scale Standard Deviation 0.6900656	1.7333333 score on a scale Standard Deviation 0.8837151	2.1428571 score on a scale Standard Deviation 0.6900656	1.4375000 score on a scale Standard Deviation 0.6291529	1.7500000 score on a scale Standard Deviation 0.4629100
Change in Quality of Life as Measured by EORTC QLQ-C30 Have you had difficulty in concentrating on things, like reading a newspaper or watching television	1.4583333 score on a scale Standard Deviation 0.7790276	1.2727273 score on a scale Standard Deviation 0.6466698	1.2857143 score on a scale Standard Deviation 0.5606119	1.2727273 score on a scale Standard Deviation 0.6466698	1.3571429 score on a scale Standard Deviation 0.7449463	1.5714286 score on a scale Standard Deviation 0.7867958	1.4000000 score on a scale Standard Deviation 0.9102590	1.5714286 score on a scale Standard Deviation 0.7867958	1.3125000 score on a scale Standard Deviation 0.6020797	1.2500000 score on a scale Standard Deviation 0.4629100
Change in Quality of Life as Measured by EORTC QLQ-C30 Did you worry?	1.9166667 score on a scale Standard Deviation 0.7755316	2.0000000 score on a scale Standard Deviation 0.6324555	1.4545455 score on a scale Standard Deviation 0.5958006	1.2727273 score on a scale Standard Deviation 0.4670994	1.3571429 score on a scale Standard Deviation 0.4972452	2.0000000 score on a scale Standard Deviation 0.8164966	1.4000000 score on a scale Standard Deviation 0.8280787	2.0000000 score on a scale Standard Deviation 0.8164966	1.4375000 score on a scale Standard Deviation 0.7274384	2.0000000 score on a scale Standard Deviation 0.7559289
Change in Quality of Life as Measured by EORTC QLQ-C30 Has your physical condition or medical treatment interfered with your social activities?	2.0416667 score on a scale Standard Deviation 0.9990938	1.9090909 score on a scale Standard Deviation 1.0444659	1.5909091 score on a scale Standard Deviation 0.7963662	1.7272727 score on a scale Standard Deviation 0.9045340	1.1428571 score on a scale Standard Deviation 0.3631365	1.7142857 score on a scale Standard Deviation 0.7559289	1.3333333 score on a scale Standard Deviation 0.6172134	1.5714286 score on a scale Standard Deviation 0.7867958	1.1250000 score on a scale Standard Deviation 0.3415650	1.3750000 score on a scale Standard Deviation 0.5175492
Change in Quality of Life as Measured by EORTC QLQ-C30 How would you rate your overall health during the past week?	5.2083333 score on a scale Standard Deviation 1.2846643	5.2727273 score on a scale Standard Deviation 0.7862454	5.4090909 score on a scale Standard Deviation 1.1815684	5.5454545 score on a scale Standard Deviation 0.8201995	5.9285714 score on a scale Standard Deviation 1.2688145	5.2857143 score on a scale Standard Deviation 1.1126973	6.0666667 score on a scale Standard Deviation 1.0327956	5.5714286 score on a scale Standard Deviation 1.1338934	5.7500000 score on a scale Standard Deviation 1.1832160	5.7500000 score on a scale Standard Deviation 0.7071068
Change in Quality of Life as Measured by EORTC QLQ-C30 Do you have trouble doing strenuous activities, like carrying a heavy shopping bag or a suitcase?	2.0000000 score on a scale Standard Deviation 0.9534626	2.0000000 score on a scale Standard Deviation 0.6324555	1.7727273 score on a scale Standard Deviation 0.9223065	1.4545455 score on a scale Standard Deviation 0.6875517	1.3571429 score on a scale Standard Deviation 0.6333237	1.7142857 score on a scale Standard Deviation 0.7559289	1.2666667 score on a scale Standard Deviation 0.5936168	1.5714286 score on a scale Standard Deviation 0.7867958	1.4375000 score on a scale Standard Deviation 0.6291529	1.6250000 score on a scale Standard Deviation 0.5175492
Change in Quality of Life as Measured by EORTC QLQ-C30 Do you have any trouble taking a long walk?	1.7500000 score on a scale Standard Deviation 0.9440892	1.0909091 score on a scale Standard Deviation 0.6015113	1.3636364 score on a scale Standard Deviation 0.5810872	1.2727273 score on a scale Standard Deviation 0.4670994	1.2142857 score on a scale Standard Deviation 0.4258153	1.1428571 score on a scale Standard Deviation 0.3779645	1.2666667 score on a scale Standard Deviation 0.4577377	1.1428571 score on a scale Standard Deviation 0.3779645	1.2500000 score on a scale Standard Deviation 0.4472136	1.2500000 score on a scale Standard Deviation 0.4629100
Change in Quality of Life as Measured by EORTC QLQ-C30 Do you have any trouble taking a short walk outside of the house?	1.0833333 score on a scale Standard Deviation 0.2823299	1.0000000 score on a scale Standard Deviation 0.0000000	1.0454545 score on a scale Standard Deviation 0.2132007	1.0000000 score on a scale Standard Deviation 0.0000000	1.0714286 score on a scale Standard Deviation 0.2672612	1.1428571 score on a scale Standard Deviation 0.3779645	1.0000000 score on a scale Standard Deviation 0.0000000	1.1428571 score on a scale Standard Deviation 0.3779645	1.0000000 score on a scale Standard Deviation 0.0000000	1.1250000 score on a scale Standard Deviation 0.3535534
Change in Quality of Life as Measured by EORTC QLQ-C30 Do you need to stay in bed or a chair during the day?	1.4583333 score on a scale Standard Deviation 0.8329709	1.0000000 score on a scale Standard Deviation 0.0000000	1.2272727 score on a scale Standard Deviation 0.5284135	1.0909091 score on a scale Standard Deviation 0.3015113	1.1428571 score on a scale Standard Deviation 0.3631365	1.2857143 score on a scale Standard Deviation 0.4879500	1.2666667 score on a scale Standard Deviation 0.4577377	1.2857143 score on a scale Standard Deviation 0.4879500	1.1875000 score on a scale Standard Deviation 0.5439056	1.0000000 score on a scale Standard Deviation 0.0000000
Change in Quality of Life as Measured by EORTC QLQ-C30 Were you limited in pursuing your hobbies or other leisure time activities?	2.0000000 score on a scale Standard Deviation 1.0215078	1.6363636 score on a scale Standard Deviation 1.0269106	1.4545455 score on a scale Standard Deviation 0.7385489	1.4545455 score on a scale Standard Deviation 0.6875517	1.2857143 score on a scale Standard Deviation 0.6112498	1.4285714 score on a scale Standard Deviation 0.7867958	1.1333333 score on a scale Standard Deviation 0.5163978	1.4285714 score on a scale Standard Deviation 0.7867958	1.2500000 score on a scale Standard Deviation 0.5773503	1.3750000 score on a scale Standard Deviation 0.7440238
Change in Quality of Life as Measured by EORTC QLQ-C30 Have you been constipated?	1.5000000 score on a scale Standard Deviation 0.7801895	1.8181818 score on a scale Standard Deviation 1.0787198	1.6363636 score on a scale Standard Deviation 0.7895420	1.0909091 score on a scale Standard Deviation 0.3015113	1.2142857 score on a scale Standard Deviation 0.4258153	1.1428571 score on a scale Standard Deviation 0.3779645	1.1333333 score on a scale Standard Deviation 0.3518658	1.5714286 score on a scale Standard Deviation 0.9759001	1.4000000 score on a scale Standard Deviation 0.8280787	1.7500000 score on a scale Standard Deviation 1.1649647
Change in Quality of Life as Measured by EORTC QLQ-C30 Did pain interfere with your daily activities?	1.6666667 score on a scale Standard Deviation 0.8164966	1.7272727 score on a scale Standard Deviation 0.6466698	1.2380952 score on a scale Standard Deviation 0.6248809	1.3000000 score on a scale Standard Deviation 0.4830459	1.2857143 score on a scale Standard Deviation 0.6112498	1.4285714 score on a scale Standard Deviation 0.7867958	1.3333333 score on a scale Standard Deviation 0.6172134	1.5714286 score on a scale Standard Deviation 0.7867958	1.1333333 score on a scale Standard Deviation 0.3518658	1.0000000 score on a scale Standard Deviation 0.0000000
Change in Quality of Life as Measured by EORTC QLQ-C30 Did you feel tense?	1.3750000 score on a scale Standard Deviation 0.6468990	1.5454545 score on a scale Standard Deviation 0.6875517	1.4090909 score on a scale Standard Deviation 0.5903262	1.2727273 score on a scale Standard Deviation 0.4670994	1.2857143 score on a scale Standard Deviation 0.4688072	1.5714286 score on a scale Standard Deviation 0.7867958	1.4000000 score on a scale Standard Deviation 0.8280787	1.4285714 score on a scale Standard Deviation 0.7867958	1.1875000 score on a scale Standard Deviation 0.4031129	1.7500000 score on a scale Standard Deviation 1.0350983
Change in Quality of Life as Measured by EORTC QLQ-C30 Did you feel irritable?	1.4166667 score on a scale Standard Deviation 0.8297022	1.5454545 score on a scale Standard Deviation 0.5222330	1.4090909 score on a scale Standard Deviation 0.6661253	1.2727273 score on a scale Standard Deviation 0.6466698	1.1428571 score on a scale Standard Deviation 0.5345225	1.7142857 score on a scale Standard Deviation 0.9511897	1.3333333 score on a scale Standard Deviation 0.8164966	1.8571429 score on a scale Standard Deviation 0.6900656	1.3125000 score on a scale Standard Deviation 0.6020797	1.6250000 score on a scale Standard Deviation 0.9161254
Change in Quality of Life as Measured by EORTC QLQ-C30 Did you feel depressed?	1.5416667 score on a scale Standard Deviation 0.8836272	1.4545455 score on a scale Standard Deviation 0.6875517	1.3181818 score on a scale Standard Deviation 0.5679004	1.1818182 score on a scale Standard Deviation 0.4045199	1.2142857 score on a scale Standard Deviation 0.4258153	1.5714286 score on a scale Standard Deviation 0.9759001	1.3333333 score on a scale Standard Deviation 0.8164966	1.7142857 score on a scale Standard Deviation 0.7559289	1.3125000 score on a scale Standard Deviation 0.6020797	1.5000000 score on a scale Standard Deviation 0.7559289
Change in Quality of Life as Measured by EORTC QLQ-C30 Have you had difficulty remembering things?	1.4166667 score on a scale Standard Deviation 0.7172815	1.2727273 score on a scale Standard Deviation 0.4670994	1.5454545 score on a scale Standard Deviation 0.8004328	1.6363636 score on a scale Standard Deviation 0.5045250	1.7142857 score on a scale Standard Deviation 0.8254203	1.8571429 score on a scale Standard Deviation 0.8997354	1.6000000 score on a scale Standard Deviation 0.6324555	2.1428571 score on a scale Standard Deviation 0.8997354	1.4375000 score on a scale Standard Deviation 0.5123475	1.8750000 score on a scale Standard Deviation 0.6408699
Change in Quality of Life as Measured by EORTC QLQ-C30 Has your physical condition or medical treatment interfered with your family life?	1.7916667 score on a scale Standard Deviation 0.8836272	1.5454545 score on a scale Standard Deviation 0.8201995	1.3181818 score on a scale Standard Deviation 0.7162311	1.3636364 score on a scale Standard Deviation 0.5045250	1.2142857 score on a scale Standard Deviation 0.4258153	1.4285714 score on a scale Standard Deviation 0.7867958	1.2000000 score on a scale Standard Deviation 0.4140393	1.5714286 score on a scale Standard Deviation 0.7867958	1.0625000 score on a scale Standard Deviation 0.2500000	1.1250000 score on a scale Standard Deviation 0.3535534
Change in Quality of Life as Measured by EORTC QLQ-C30 Has your physical condition or medical treatment caused you financial difficulties?	1.5416667 score on a scale Standard Deviation 1.0206207	2.3636364 score on a scale Standard Deviation 1.2060454	1.5909091 score on a scale Standard Deviation 0.9591212	1.9090909 score on a scale Standard Deviation 1.0444659	1.7142857 score on a scale Standard Deviation 0.9944903	2.1428571 score on a scale Standard Deviation 1.0690450	1.4666667 score on a scale Standard Deviation 1.0600988	1.8571429 score on a scale Standard Deviation 0.8997354	1.4375000 score on a scale Standard Deviation 0.8139410	1.8750000 score on a scale Standard Deviation 0.9910312
Change in Quality of Life as Measured by EORTC QLQ-C30 How would you rate your overall quality of life during the past week?	5.0416667 score on a scale Standard Deviation 1.3666578	5.1818182 score on a scale Standard Deviation 0.7507572	5.6363636 score on a scale Standard Deviation 1.2167660	5.6363636 score on a scale Standard Deviation 0.8090398	6.1428571 score on a scale Standard Deviation 1.3506205	5.4285714 score on a scale Standard Deviation 0.7867958	6.1333333 score on a scale Standard Deviation 1.0600988	5.7142857 score on a scale Standard Deviation 1.1126973	6.0000000 score on a scale Standard Deviation 1.0954451	6.0000000 score on a scale Standard Deviation 0.5345225

Adverse Events

Radiotherapy

Serious events: 0 serious events

Other events: 26 other events

Deaths: 1 deaths

Radiotherapy, Cisplatin

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Radiotherapy n=27 participants at risk * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	Radiotherapy, Cisplatin n=11 participants at risk * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways
Gastrointestinal disorders Xerostomia	0.00% 0/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	9.1% 1/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Metabolism and nutrition disorders Anorexia	0.00% 0/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	9.1% 1/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	9.1% 1/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)

Other adverse events

Measure	Radiotherapy n=27 participants at risk * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways	Radiotherapy, Cisplatin n=11 participants at risk * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways
Gastrointestinal disorders Diarrhea	7.4% 2/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	27.3% 3/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Gastrointestinal disorders Dry mouth	40.7% 11/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	81.8% 9/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Gastrointestinal disorders Dyspepsia	3.7% 1/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	45.5% 5/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Gastrointestinal disorders Dysphagia	22.2% 6/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	45.5% 5/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Gastrointestinal disorders Mucositis oral	40.7% 11/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	72.7% 8/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Gastrointestinal disorders Nausea	18.5% 5/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	81.8% 9/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Gastrointestinal disorders Odynophagia	11.1% 3/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	36.4% 4/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Gastrointestinal disorders Oral pain	3.7% 1/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	9.1% 1/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Gastrointestinal disorders Salivary duct inflammation	14.8% 4/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	9.1% 1/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Gastrointestinal disorders Vomiting	7.4% 2/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	18.2% 2/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
General disorders Chills	3.7% 1/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	9.1% 1/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
General disorders Edema limbs	0.00% 0/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	9.1% 1/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
General disorders Fatigue	14.8% 4/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	54.5% 6/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
General disorders Injection site reaction	0.00% 0/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	9.1% 1/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
General disorders Localized edema	7.4% 2/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	9.1% 1/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
General disorders Pain - oropharynx	11.1% 3/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	0.00% 0/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
General disorders Pain-chest (non-cardiac)	0.00% 0/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	9.1% 1/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Infections and infestations Cellulitis	0.00% 0/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	9.1% 1/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Infections and infestations Hand infection	0.00% 0/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	9.1% 1/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Infections and infestations Laryngitis	0.00% 0/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	9.1% 1/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Infections and infestations Oral thrush	14.8% 4/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	0.00% 0/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Injury, poisoning and procedural complications Dermatitis radiation	48.1% 13/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	90.9% 10/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Investigations Alanine aminotransferase increased	0.00% 0/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	9.1% 1/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Investigations Creatinine increased	0.00% 0/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	9.1% 1/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Blood and lymphatic system disorders Anemia	7.4% 2/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	81.8% 9/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	9.1% 1/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Cardiac disorders Atrial fibrillation	0.00% 0/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	9.1% 1/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Ear and labyrinth disorders Ear pain	7.4% 2/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	0.00% 0/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Ear and labyrinth disorders Hearing impaired	3.7% 1/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	9.1% 1/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Ear and labyrinth disorders Middle ear inflammation	7.4% 2/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	0.00% 0/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Ear and labyrinth disorders Tinnitus	3.7% 1/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	9.1% 1/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Gastrointestinal disorders Constipation	11.1% 3/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	63.6% 7/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Investigations Lymphocyte count decreased	33.3% 9/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	90.9% 10/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Investigations Neutrophil count decreased	0.00% 0/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	54.5% 6/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Investigations Platelet count decreased	0.00% 0/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	81.8% 9/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Investigations Weight loss	11.1% 3/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	36.4% 4/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Investigations White blood cell decreased	11.1% 3/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	90.9% 10/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Metabolism and nutrition disorders Anorexia	3.7% 1/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	54.5% 6/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Metabolism and nutrition disorders Dehydration	3.7% 1/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	9.1% 1/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Metabolism and nutrition disorders Hypercalcemia	3.7% 1/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	0.00% 0/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	18.2% 2/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Metabolism and nutrition disorders Hyperkalemia	3.7% 1/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	9.1% 1/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Metabolism and nutrition disorders Hypernatremia	3.7% 1/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	0.00% 0/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	36.4% 4/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Metabolism and nutrition disorders Hypocalcemia	3.7% 1/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	27.3% 3/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Metabolism and nutrition disorders Hypokalemia	0.00% 0/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	9.1% 1/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	36.4% 4/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Metabolism and nutrition disorders Hyponatremia	0.00% 0/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	54.5% 6/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Musculoskeletal and connective tissue disorders Arthralgia	3.7% 1/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	0.00% 0/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Musculoskeletal and connective tissue disorders Back pain	3.7% 1/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	9.1% 1/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Musculoskeletal and connective tissue disorders Joint range decrease	0.00% 0/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	9.1% 1/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Musculoskeletal and connective tissue disorders Myalgia	3.7% 1/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	0.00% 0/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	18.2% 2/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Musculoskeletal and connective tissue disorders Pain in extremity	11.1% 3/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	9.1% 1/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Musculoskeletal and connective tissue disorders Trismus	11.1% 3/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	0.00% 0/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Nervous system disorders Anosmia	3.7% 1/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	0.00% 0/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Nervous system disorders Dizziness	3.7% 1/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	18.2% 2/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Nervous system disorders Dysarthria	7.4% 2/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	0.00% 0/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Nervous system disorders Dysgeusia	48.1% 13/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	63.6% 7/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Nervous system disorders Headache	11.1% 3/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	54.5% 6/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Nervous system disorders Paresthesia	7.4% 2/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	0.00% 0/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	18.2% 2/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Psychiatric disorders Anxiety	0.00% 0/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	18.2% 2/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Psychiatric disorders Depression	3.7% 1/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	18.2% 2/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Psychiatric disorders Insomnia	11.1% 3/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	18.2% 2/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Respiratory, thoracic and mediastinal disorders Cough	14.8% 4/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	18.2% 2/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Respiratory, thoracic and mediastinal disorders Dry nasal cavity	3.7% 1/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	0.00% 0/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	9.1% 1/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Respiratory, thoracic and mediastinal disorders Epistaxis	3.7% 1/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	9.1% 1/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	18.2% 2/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Respiratory, thoracic and mediastinal disorders Nasal congestion	3.7% 1/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	0.00% 0/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Respiratory, thoracic and mediastinal disorders Post nasal drip	0.00% 0/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	18.2% 2/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Respiratory, thoracic and mediastinal disorders Productive cough	3.7% 1/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	9.1% 1/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Respiratory, thoracic and mediastinal disorders Sore throat	25.9% 7/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	27.3% 3/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Skin and subcutaneous tissue disorders Alopecia	29.6% 8/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	81.8% 9/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Skin and subcutaneous tissue disorders Desquamation	0.00% 0/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	9.1% 1/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Skin and subcutaneous tissue disorders Dry skin	3.7% 1/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	0.00% 0/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Skin and subcutaneous tissue disorders Hyperhidrosis	3.7% 1/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	0.00% 0/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia	0.00% 0/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	9.1% 1/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	9.1% 1/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Skin and subcutaneous tissue disorders Skin hyperpigmentation	7.4% 2/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	0.00% 0/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Vascular disorders Hot flashes	3.7% 1/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	0.00% 0/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Vascular disorders Lymphedema	0.00% 0/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	9.1% 1/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Vascular disorders Phlebitis	0.00% 0/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	9.1% 1/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Vascular disorders Thromboembolic event	0.00% 0/27 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)	18.2% 2/11 • Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)

Additional Information

Jason Rich, M.D.

Washington University School of Medicine

Phone: 314-747-3742

Email: richj@wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place