Trial Outcomes & Findings for Cisplatin + Radiation in SCCHN and Correlation With Oxidative Stress Markers (NCT NCT02994069)

NCT ID: NCT02994069

Last Updated: 2025-10-14

Results Overview

Rate of grade 3-5 cisplatin-related adverse events expressed as a percentage of each cohort of patients occurring within 90 days of initiation of concurrent radiation and chemotherapy; Rate calculated from number of patients with at least one cisplatin-related AEs with grade 3-5 within 90 days of the 1st treatment. This primary endpoint is the percentage of subjects experiencing cisplatin-related actual toxicities in each group estimated along with exact 95% binomial confidence intervals.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 80 participants
• Primary outcome timeframe: 90 days
• Results posted on: 2025-10-14

Participant Flow

Participant milestones

Measure	Every 3 Weeks Cisplatin + XRT Every 3 Weeks Cisplatin + XRT Cisplatin: Cisplatin XRT: Radiation Therapy	Weekly Cisplatin + XRT Weekly Cisplatin + XRT Cisplatin: Cisplatin XRT: Radiation Therapy
Overall Study STARTED	39	41
Overall Study Cohort 1	30	32
Overall Study Cohort 2	9	9
Overall Study COMPLETED	24	22
Overall Study NOT COMPLETED	15	19

Reasons for withdrawal

Measure	Every 3 Weeks Cisplatin + XRT Every 3 Weeks Cisplatin + XRT Cisplatin: Cisplatin XRT: Radiation Therapy	Weekly Cisplatin + XRT Weekly Cisplatin + XRT Cisplatin: Cisplatin XRT: Radiation Therapy
Overall Study Death	7	13
Overall Study Adverse Event	1	0
Overall Study Other	2	0
Overall Study still on follow up/treatment	5	6

Baseline Characteristics

Cisplatin + Radiation in SCCHN and Correlation With Oxidative Stress Markers

Baseline characteristics by cohort

Measure	Every 3 Weeks Cisplatin + XRT n=39 Participants Every 3 Weeks Cisplatin + XRT Cisplatin: Cisplatin XRT: Radiation Therapy	Weekly Cisplatin + XRT n=41 Participants Weekly Cisplatin + XRT Cisplatin: Cisplatin XRT: Radiation Therapy	Total n=80 Participants Total of all reporting groups
Age, Continuous	56.26 years STANDARD_DEVIATION 9.33 • n=5 Participants	59.07 years STANDARD_DEVIATION 8.23 • n=7 Participants	57.7 years STANDARD_DEVIATION 8.84 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	30 Participants n=7 Participants	57 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=5 Participants	40 Participants n=7 Participants	78 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	1 Participants n=5 Participants	0 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	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	35 Participants n=5 Participants	38 Participants n=7 Participants	73 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants	41 participants n=7 Participants	80 participants n=5 Participants

PRIMARY outcome

Timeframe: 90 days

Rate of grade 3-5 cisplatin-related adverse events expressed as a percentage of each cohort of patients occurring within 90 days of initiation of concurrent radiation and chemotherapy; Rate calculated from number of patients with at least one cisplatin-related AEs with grade 3-5 within 90 days of the 1st treatment. This primary endpoint is the percentage of subjects experiencing cisplatin-related actual toxicities in each group estimated along with exact 95% binomial confidence intervals.

Outcome measures

Measure	Every 3 Weeks Cisplatin + XRT n=39 Participants Every 3 Weeks Cisplatin + XRT Cisplatin: Cisplatin XRT: Radiation Therapy	Weekly Cisplatin + XRT n=41 Participants Weekly Cisplatin + XRT Cisplatin: Cisplatin XRT: Radiation Therapy
CTCAE Grade 3-5 Cisplatin-related Adverse Event Rate (Percentage)	74.36 percentage of participants Standard Deviation 6.99	68.29 percentage of participants Standard Deviation 7.27

SECONDARY outcome

Timeframe: 2 years

2 year local control rate

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Overall survival

Outcome measures

Measure	Every 3 Weeks Cisplatin + XRT n=39 Participants Every 3 Weeks Cisplatin + XRT Cisplatin: Cisplatin XRT: Radiation Therapy	Weekly Cisplatin + XRT n=41 Participants Weekly Cisplatin + XRT Cisplatin: Cisplatin XRT: Radiation Therapy
Survival	687.5 days Standard Deviation 10.45	517.06 days Standard Deviation 14.71

Adverse Events

Every 3 Weeks Cisplatin + XRT

Serious events: 39 serious events

Other events: 8 other events

Deaths: 7 deaths

Weekly Cisplatin + XRT

Serious events: 41 serious events

Other events: 10 other events

Deaths: 13 deaths

Serious adverse events

Measure	Every 3 Weeks Cisplatin + XRT n=39 participants at risk Every 3 Weeks Cisplatin + XRT Cisplatin: Cisplatin XRT: Radiation Therapy	Weekly Cisplatin + XRT n=41 participants at risk Weekly Cisplatin + XRT Cisplatin: Cisplatin XRT: Radiation Therapy
Blood and lymphatic system disorders Anemia	2.6% 1/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	7.3% 3/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Blood and lymphatic system disorders Febrile Neutropenia	5.1% 2/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	9.8% 4/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Blood and lymphatic system disorders Other	2.6% 1/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	0.00% 0/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Ear and labyrinth disorders Tinnitus	12.8% 5/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	2.4% 1/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Gastrointestinal disorders Dysphagia	17.9% 7/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	9.8% 4/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Gastrointestinal disorders Mucositis Oral	28.2% 11/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	36.6% 15/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Gastrointestinal disorders Nausea	25.6% 10/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	4.9% 2/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Gastrointestinal disorders Vomiting	28.2% 11/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	7.3% 3/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Gastrointestinal disorders Oral Pain	2.6% 1/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	31.7% 13/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
General disorders Fatigue	2.6% 1/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	7.3% 3/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Infections and infestations Sinusitis	2.6% 1/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	0.00% 0/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Ear and labyrinth disorders Ear Pain	0.00% 0/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	2.4% 1/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Gastrointestinal disorders Esophagitis	0.00% 0/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	2.4% 1/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
General disorders pain	0.00% 0/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	2.4% 1/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Infections and infestations Bronchial Infection	0.00% 0/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	2.4% 1/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Infections and infestations Mucosal Infection	0.00% 0/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	2.4% 1/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Infections and infestations Other	0.00% 0/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	4.9% 2/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Infections and infestations Urinary Tract Infection	0.00% 0/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	2.4% 1/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Injury, poisoning and procedural complications Dermatitis radiation	2.6% 1/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	2.4% 1/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Investigations Weight loss	0.00% 0/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	2.4% 1/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Investigations White blood cell decreased	25.6% 10/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	29.3% 12/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Investigations Lymphocyte count decreased	2.6% 1/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	2.4% 1/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Investigations Neutrophil count decreased	20.5% 8/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	4.9% 2/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Investigations CD4 lymphocytes decreased	2.6% 1/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	0.00% 0/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Metabolism and nutrition disorders Dehydration	12.8% 5/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	7.3% 3/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Metabolism and nutrition disorders Hypokalemia	2.6% 1/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	4.9% 2/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Metabolism and nutrition disorders Hypocalcemia	2.6% 1/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	0.00% 0/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Metabolism and nutrition disorders Anorexia	0.00% 0/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	2.4% 1/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	2.4% 1/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Musculoskeletal and connective tissue disorders Generalized muscle weakness	2.6% 1/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	0.00% 0/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	2.4% 1/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Nervous system disorders Syncope	2.6% 1/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	0.00% 0/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Nervous system disorders Peripheral motor neuropathy	0.00% 0/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	2.4% 1/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Psychiatric disorders Delirium	0.00% 0/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	2.4% 1/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Respiratory, thoracic and mediastinal disorders Sore throat	2.6% 1/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	0.00% 0/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Respiratory, thoracic and mediastinal disorders Hoarseness	2.6% 1/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	0.00% 0/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Skin and subcutaneous tissue disorders Other	2.6% 1/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	0.00% 0/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Vascular disorders Hypotension	2.6% 1/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	2.4% 1/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Vascular disorders Hematuria	0.00% 0/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	2.4% 1/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events

Other adverse events

Measure	Every 3 Weeks Cisplatin + XRT n=39 participants at risk Every 3 Weeks Cisplatin + XRT Cisplatin: Cisplatin XRT: Radiation Therapy	Weekly Cisplatin + XRT n=41 participants at risk Weekly Cisplatin + XRT Cisplatin: Cisplatin XRT: Radiation Therapy
Blood and lymphatic system disorders Other	2.6% 1/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	0.00% 0/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Gastrointestinal disorders Constipation	2.6% 1/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	4.9% 2/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Gastrointestinal disorders Dysphagia	2.6% 1/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	2.4% 1/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Gastrointestinal disorders Mucositis oral	2.6% 1/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	7.3% 3/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Gastrointestinal disorders Nausea	5.1% 2/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	2.4% 1/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Gastrointestinal disorders Oral dysesthesia	2.6% 1/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	0.00% 0/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Gastrointestinal disorders Vomiting	2.6% 1/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	2.4% 1/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Gastrointestinal disorders Diarrhea	0.00% 0/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	2.4% 1/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events
Gastrointestinal disorders Dry mouth	0.00% 0/39 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events	2.4% 1/41 • 2 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting; Grade 3 or higher treatment related Adverse Events are listed as serious adverse events

Additional Information

Dr. Susanne Arnold

University of Kentucky

Phone: 859-323-6522

Email: susanne.arnold@uky.edu

Results disclosure agreements

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