Trial Outcomes & Findings for De-Escalation Radiotherapy in Patients With Low-Risk HPV-Related Oropharyngeal Squamous Cell Carcinoma (NCT NCT03822897)

Last Updated: 2025-09-30

Results Overview

Event free survival (EFS) is defined as the time from the date of registration to the date of first record of any of the following events: * Progression. * Surgery. * Non-protocol RT, chemotherapy, or biologic therapy (for the current cancer diagnosis) without documentation of the site of failure. * Death due to any cause. The outcome is reported as the proportion of patients who remain event-free at 2 years.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

103 participants

Primary outcome timeframe

2 years

Results posted on

2025-09-30

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental Arm Elective volume adjusted de-escalation radiotherapy. Option #1 - Radiotherapy 35 fractions, 5/wk, 7 wks 70Gy/56Gy Cisplatin 100mg/m2 on day 1, 22 and 43 or 40mg mg/m2/wk for 7 wks Option #2 - Radiation only-35 fraction, 6/wk, 6wks 70Gy/56Gy
Overall Study STARTED	103
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental Arm n=103 Participants Elective volume adjusted de-escalation radiotherapy. Option #1 - Radiotherapy 35 fractions, 5/wk, 7 wks 70Gy/56Gy Cisplatin 100mg/m2 on day 1, 22 and 43 or 40mg mg/m2/wk for 7 wks Option #2 - Radiation only-35 fraction, 6/wk, 6wks 70Gy/56Gy
Age, Continuous	62.8 years n=103 Participants
Sex: Female, Male Female	18 Participants n=103 Participants
Sex: Female, Male Male	85 Participants n=103 Participants
ECOG Performance Status 0	82 Participants n=103 Participants
ECOG Performance Status 1	21 Participants n=103 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Experimental Arm n=99 Participants Elective volume adjusted de-escalation radiotherapy. Option #1 - Radiotherapy 35 fractions, 5/wk, 7 wks 70Gy/56Gy Cisplatin 100mg/m2 on day 1, 22 and 43 or 40mg mg/m2/wk for 7 wks Option #2 - Radiation only-35 fraction, 6/wk, 6wks 70Gy/56Gy
Event-free Survival	91.8 Percentage of patients event-free at 2y Interval 86.6 to 97.4

SECONDARY outcome

Timeframe: 2 years

For patients who have died, overall survival is calculated in months from the day of registration to date of death. Otherwise, overall survival is censored at the last day the patient is known alive (LKA). The outcome is reported as the proportion of patients who remain alive at 2 years.

Outcome measures

Outcome measures
Measure	Experimental Arm n=99 Participants Elective volume adjusted de-escalation radiotherapy. Option #1 - Radiotherapy 35 fractions, 5/wk, 7 wks 70Gy/56Gy Cisplatin 100mg/m2 on day 1, 22 and 43 or 40mg mg/m2/wk for 7 wks Option #2 - Radiation only-35 fraction, 6/wk, 6wks 70Gy/56Gy
Overall Survival	94.7 Percentage of patients alive at 2 years Interval 90.2 to 99.3

SECONDARY outcome

Timeframe: 2 years

Local-regional control is defined as the time from the date of registration to the date of any of the following, whichever comes first: * Surgery of primary tumour at any time performed for clinical or radiological disease persistence/progression/recurrence with tumour present/unknown on final pathology. * Neck dissection \> 20 weeks from the end of radiation therapy performed for clinical or radiological (RECIST 1.1) disease persistence/progression/recurrence within target volumes with tumour present/unknown on final pathology. * Neck dissection at any time after registration performed for clinical or radiological disease recurrence/progression outside the target volumes or without documentation of the site of failure with tumour present/unknown on final pathology. * the first record of appearance (radiological or clinical) of local or regional disease progression. The outcome is reported as the proportion of patients who remain local-regional control free at 2 years.

Outcome measures

Outcome measures
Measure	Experimental Arm n=99 Participants Elective volume adjusted de-escalation radiotherapy. Option #1 - Radiotherapy 35 fractions, 5/wk, 7 wks 70Gy/56Gy Cisplatin 100mg/m2 on day 1, 22 and 43 or 40mg mg/m2/wk for 7 wks Option #2 - Radiation only-35 fraction, 6/wk, 6wks 70Gy/56Gy
Local-regional Control	94.8 Percentage of patients LRC free at 2y Interval 90.5 to 99.3

SECONDARY outcome

Timeframe: 2 years

Time to out-of-field regional failure is defined as the time from the date of registration to the date of the first record of appearance of regional progression/recurrence outside the treatment field , or to the date of neck dissection at any time after registration with tumour present/unknown performed for clinical or radiological disease progression outside the target volumes whichever comes first. The outcome is reported as the proportion of patients who remain out-of-field regional control free at 2 years.

Outcome measures

Outcome measures
Measure	Experimental Arm n=99 Participants Elective volume adjusted de-escalation radiotherapy. Option #1 - Radiotherapy 35 fractions, 5/wk, 7 wks 70Gy/56Gy Cisplatin 100mg/m2 on day 1, 22 and 43 or 40mg mg/m2/wk for 7 wks Option #2 - Radiation only-35 fraction, 6/wk, 6wks 70Gy/56Gy
Out-of-field Regional Control	99 Percentages of patients ORC free at 2y Interval 97.0 to 100.0

SECONDARY outcome

Timeframe: 2 years

Distant metastasis free survival is defined as the time from the date of registration to the date of first record of appearance of distant metastasis or death for any cause. Local-regional failure or second cancers diagnosed before the distant metastases are not considered events of interest for this endpoint. Subjects alive and free of distant metastasis are censored at the date of the most recent follow-up examination. The outcome is reported as the proportion of patients who remain distant metastasis event-free at 2 years.

Outcome measures

Outcome measures
Measure	Experimental Arm n=99 Participants Elective volume adjusted de-escalation radiotherapy. Option #1 - Radiotherapy 35 fractions, 5/wk, 7 wks 70Gy/56Gy Cisplatin 100mg/m2 on day 1, 22 and 43 or 40mg mg/m2/wk for 7 wks Option #2 - Radiation only-35 fraction, 6/wk, 6wks 70Gy/56Gy
Distant Metastasis Free Survival	91.3 Percentages of patients DMF at 2y Interval 84.7 to 98.3

Adverse Events

Experimental Arm

Serious events: 8 serious events

Other events: 100 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Experimental Arm n=100 participants at risk Elective volume adjusted de-escalation radiotherapy. Option #1 - Radiotherapy 35 fractions, 5/wk, 7 wks 70Gy/56Gy Cisplatin 100mg/m2 on day 1, 22 and 43 or 40mg mg/m2/wk for 7 wks Option #2 - Radiation only-35 fraction, 6/wk, 6wks 70Gy/56Gy
Gastrointestinal disorders Dysphagia	1.0% 1/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Gastrointestinal disorders Nausea	2.0% 2/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Gastrointestinal disorders Vomiting	2.0% 2/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Gastrointestinal disorders Other gastrointestinal disorders	1.0% 1/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Infections and infestations Lung infection	1.0% 1/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Infections and infestations Sepsis	1.0% 1/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Metabolism and nutrition disorders Dehydration	3.0% 3/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Renal and urinary disorders Acute kidney injury	1.0% 1/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.0% 2/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.

Other adverse events

Other adverse events
Measure	Experimental Arm n=100 participants at risk Elective volume adjusted de-escalation radiotherapy. Option #1 - Radiotherapy 35 fractions, 5/wk, 7 wks 70Gy/56Gy Cisplatin 100mg/m2 on day 1, 22 and 43 or 40mg mg/m2/wk for 7 wks Option #2 - Radiation only-35 fraction, 6/wk, 6wks 70Gy/56Gy
Ear and labyrinth disorders Ear pain	14.0% 14/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Ear and labyrinth disorders Hearing impaired	6.0% 6/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Ear and labyrinth disorders Tinnitus	26.0% 26/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Gastrointestinal disorders Constipation	39.0% 39/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Gastrointestinal disorders Diarrhea	6.0% 6/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Gastrointestinal disorders Dry mouth	94.0% 94/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Gastrointestinal disorders Dysphagia	49.0% 49/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Gastrointestinal disorders Mucositis oral	82.0% 82/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Gastrointestinal disorders Nausea	36.0% 36/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Gastrointestinal disorders Oral pain	23.0% 23/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Gastrointestinal disorders Salivary duct inflammation	7.0% 7/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Gastrointestinal disorders Vomiting	16.0% 16/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Gastrointestinal disorders Other gastrointestinal disorders	34.0% 34/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
General disorders Fatigue	52.0% 52/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
General disorders Neck edema	6.0% 6/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
General disorders Pain	9.0% 9/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Infections and infestations Thrush	10.0% 10/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Injury, poisoning and procedural complications Dermatitis radiation	78.0% 78/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Investigations Neutrophil count decreased	8.0% 8/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Investigations Weight loss	34.0% 34/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Metabolism and nutrition disorders Anorexia	24.0% 24/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Metabolism and nutrition disorders Dehydration	13.0% 13/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Musculoskeletal and connective tissue disorders Neck pain	12.0% 12/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Musculoskeletal and connective tissue disorders Superficial soft tissue fibrosis	19.0% 19/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Nervous system disorders Dizziness	11.0% 11/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Nervous system disorders Dysgeusia	86.0% 86/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Nervous system disorders Headache	8.0% 8/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Nervous system disorders Paresthesia	9.0% 9/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Nervous system disorders Peripheral sensory neuropathy	6.0% 6/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Psychiatric disorders Anxiety	13.0% 13/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Psychiatric disorders Insomnia	13.0% 13/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Respiratory, thoracic and mediastinal disorders Cough	8.0% 8/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Respiratory, thoracic and mediastinal disorders Hiccups	6.0% 6/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Respiratory, thoracic and mediastinal disorders Hoarseness	12.0% 12/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	17.0% 17/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
Respiratory, thoracic and mediastinal disorders Sore throat	19.0% 19/100 • Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter. Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.

Additional Information

Dr. Wendy Ranjana Parulekar

Canadian Cancer Trials Group

Phone: 613 533 6430

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place