Trial Outcomes & Findings for Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal Cancer (NCT NCT01302834)

Last Updated: 2026-01-12

Results Overview

An event for overall survival is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is hazard ratio, which is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

987 participants

Primary outcome timeframe

From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.

Results posted on

2026-01-12

Participant Flow

Sites were required to submit participant tumor tissue for central p16 evaluation within one week of registration. If participants were determined to be p16-positive and continued on the study, then treatment arm was assigned. Of 987 participants registered, 849 were randomized.

Participant milestones

Participant milestones
Measure	IMRT + Cisplatin Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Overall Study STARTED	424	425
Overall Study Eligible	406	399
Overall Study Started Treatment	398	394
Overall Study AE Assessed 1 Month Post-treatment (PT)	369	363
Overall Study AE Assessed 3 Months PT	359	367
Overall Study AE Assessed 6 Months PT	361	352
Overall Study AE Assessment 1 Year PT	360	351
Overall Study AE Assessed 2 Years PT	311	303
Overall Study AE Assessed 5 Years PT	92	86
Overall Study Dental Health Assessed 1 Year PT	267	267
Overall Study Dental Health Assessed 2 Years PT	208	201
Overall Study Dental Health Assessed 5 Years PT	44	43
Overall Study Feeding Tube Assessed	368	356
Overall Study Progressed	76	122
Overall Study COMPLETED	406	399
Overall Study NOT COMPLETED	18	26

Reasons for withdrawal

Reasons for withdrawal
Measure	IMRT + Cisplatin Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Overall Study Protocol Violation	17	23
Overall Study HIV positive	1	3

Baseline Characteristics

Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IMRT + Cisplatin n=406 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=399 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	Total n=805 Participants Total of all reporting groups
Age, Continuous	58 years n=210 Participants	58 years n=19 Participants	58 years n=8 Participants
Age, Customized <= 65	344 Participants n=210 Participants	345 Participants n=19 Participants	689 Participants n=8 Participants
Age, Customized > 65	62 Participants n=210 Participants	54 Participants n=19 Participants	116 Participants n=8 Participants
Sex: Female, Male Female	33 Participants n=210 Participants	44 Participants n=19 Participants	77 Participants n=8 Participants
Sex: Female, Male Male	373 Participants n=210 Participants	355 Participants n=19 Participants	728 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=210 Participants	15 Participants n=19 Participants	26 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	383 Participants n=210 Participants	369 Participants n=19 Participants	752 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	12 Participants n=210 Participants	15 Participants n=19 Participants	27 Participants n=8 Participants
Race/Ethnicity, Customized White	380 Participants n=210 Participants	367 Participants n=19 Participants	747 Participants n=8 Participants
Race/Ethnicity, Customized Black	17 Participants n=210 Participants	19 Participants n=19 Participants	36 Participants n=8 Participants
Race/Ethnicity, Customized Other	2 Participants n=210 Participants	8 Participants n=19 Participants	10 Participants n=8 Participants
Race/Ethnicity, Customized Unknown	7 Participants n=210 Participants	5 Participants n=19 Participants	12 Participants n=8 Participants
Zubrod performance status 0	295 Participants n=210 Participants	300 Participants n=19 Participants	595 Participants n=8 Participants
Zubrod performance status 1	111 Participants n=210 Participants	99 Participants n=19 Participants	210 Participants n=8 Participants
Smoking history 0 pack-years	194 Participants n=210 Participants	181 Participants n=19 Participants	375 Participants n=8 Participants
Smoking history >0 to <= 10 pack-years	59 Participants n=210 Participants	68 Participants n=19 Participants	127 Participants n=8 Participants
Smoking history >10 pack-years	153 Participants n=210 Participants	150 Participants n=19 Participants	303 Participants n=8 Participants
Smoking history	2 pack-years n=210 Participants	3 pack-years n=19 Participants	2 pack-years n=8 Participants
Primary site Tonsillar fossa, tonsil	202 Participants n=210 Participants	199 Participants n=19 Participants	401 Participants n=8 Participants
Primary site Base of tongue	174 Participants n=210 Participants	179 Participants n=19 Participants	353 Participants n=8 Participants
Primary site Oropharynx, not otherwise specified	16 Participants n=210 Participants	15 Participants n=19 Participants	31 Participants n=8 Participants
Primary site Pharyngeal oropharynx	8 Participants n=210 Participants	5 Participants n=19 Participants	13 Participants n=8 Participants
Primary site Soft palate	4 Participants n=210 Participants	0 Participants n=19 Participants	4 Participants n=8 Participants
Primary site Vallecula	2 Participants n=210 Participants	1 Participants n=19 Participants	3 Participants n=8 Participants
Tumor stage T1	89 Participants n=210 Participants	86 Participants n=19 Participants	175 Participants n=8 Participants
Tumor stage T2	162 Participants n=210 Participants	163 Participants n=19 Participants	325 Participants n=8 Participants
Tumor stage T3	108 Participants n=210 Participants	100 Participants n=19 Participants	208 Participants n=8 Participants
Tumor stage T4	47 Participants n=210 Participants	50 Participants n=19 Participants	97 Participants n=8 Participants
Node category N0	20 Participants n=210 Participants	14 Participants n=19 Participants	34 Participants n=8 Participants
Node category N1	20 Participants n=210 Participants	25 Participants n=19 Participants	45 Participants n=8 Participants
Node category N2a	59 Participants n=210 Participants	56 Participants n=19 Participants	115 Participants n=8 Participants
Node category N2b	209 Participants n=210 Participants	208 Participants n=19 Participants	417 Participants n=8 Participants
Node category N2c	82 Participants n=210 Participants	83 Participants n=19 Participants	165 Participants n=8 Participants
Node category N3	16 Participants n=210 Participants	13 Participants n=19 Participants	29 Participants n=8 Participants
Overall stage III	29 Participants n=210 Participants	31 Participants n=19 Participants	60 Participants n=8 Participants
Overall stage IV	377 Participants n=210 Participants	368 Participants n=19 Participants	745 Participants n=8 Participants
Risk group per study RTOG-0129 Low risk	289 Participants n=210 Participants	284 Participants n=19 Participants	573 Participants n=8 Participants
Risk group per study RTOG-0129 Intermediate risk	117 Participants n=210 Participants	115 Participants n=19 Participants	232 Participants n=8 Participants

PRIMARY outcome

Timeframe: From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.

Population: Eligible participants

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=406 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=399 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Overall Survival	84.6 percentage of participants Interval 80.6 to 88.6	77.9 percentage of participants Interval 73.4 to 82.5

SECONDARY outcome

Population: Eligible participants

An event for progression-free survival is local, regional, or distant disease progression or death due to any cause. Progression-free survival time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is the distribution of progression-free survival times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=406 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=399 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Progression-free Survival	78.4 percentage of participants Interval 73.8 to 83.0	67.3 percentage of participants Interval 62.4 to 72.2

SECONDARY outcome

Population: Eligible participants

Failure for local-regional failure endpoint was defined as local or regional progression, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown \> 20 weeks after the end of radiation therapy, death due to study cancer without documented progression, or death due to unknown causes without documented progression; distant metastasis and death due to other causes were considered competing risks. Local-regional failure time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method. The protocol endpoint is the distribution of local-regional failure times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=406 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=399 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Time to Local-regional Failure	9.9 percentage of participants Interval 6.9 to 13.6	17.3 percentage of participants Interval 13.7 to 21.4

SECONDARY outcome

Population: Eligible participants

Failure for distant metastasis endpoint was defined as distant progression; local-regional failure and death due to any cause were considered competing risks. Distant metastasis time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method. The protocol endpoint is the distribution of distant metastasis times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=406 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=399 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Time to Distant Metastasis	8.6 percentage of participants Interval 5.8 to 11.9	11.7 percentage of participants Interval 8.6 to 15.3

SECONDARY outcome

Population: Eligible participants

Failure for second primary endpoint was defined as reporting of a new primary cancer; death due to any cause was considered a competing risk. Second primary time is defined as time from randomization to the date of second primary or last known follow-up (censored). Rates are estimated by the cumulative incidence method. The protocol endpoint is the distribution of second primary cancer times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=406 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=399 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Time to Secondary Primary Cancer	9.9 percentage of participants Interval 6.9 to 13.4	10.3 percentage of participants Interval 7.1 to 14.2

SECONDARY outcome

Population: Eligible participants with progression-free survival failure

The first event type for progression-free survival is counted for each participant. Possible first progression events are local, regional, or distant progression, any combination of these, or death. The frequency table of these events is also referred to as "Pattern of failure."

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=76 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=122 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Distribution of First Progression Events Local and distant	0 Participants	1 Participants
Distribution of First Progression Events Regional and distant	0 Participants	5 Participants
Distribution of First Progression Events Local, regional, and distant	0 Participants	2 Participants
Distribution of First Progression Events Distant	31 Participants	43 Participants
Distribution of First Progression Events Death, due to this disease	2 Participants	0 Participants
Distribution of First Progression Events Death, due to second primary	1 Participants	3 Participants
Distribution of First Progression Events Death, due to other reason	10 Participants	11 Participants
Distribution of First Progression Events Death, due to unknown reason	9 Participants	10 Participants
Distribution of First Progression Events Local	13 Participants	25 Participants
Distribution of First Progression Events Regional	6 Participants	14 Participants
Distribution of First Progression Events Local and regional	4 Participants	8 Participants

SECONDARY outcome

Population: Eligible patients who started study treatment

Early death is defined as death due to adverse event or within 30 days of treatment completion.

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=398 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=394 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Percentage of Participants Experiencing Early Death	1.5 percentage of participants Interval 0.6 to 3.3	1.5 percentage of participants Interval 0.6 to 3.3

SECONDARY outcome

Timeframe: From start of treatment to end of treatment, approximately 6 weeks

Population: All eligible patients who started study treatment

Acute adverse events (AE) are defined as occurring within 180 days from the end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=398 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=394 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: During Treatment	75.6 percentage of participants Interval 71.1 to 79.8	73.6 percentage of participants Interval 69.0 to 77.9

SECONDARY outcome

Timeframe: From start of treatment to approximately 2.5 months (1 month after the end of treatment)

Population: Eligible patients who started study treatment and had adverse events assessment at 1 month after treatment end

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=369 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=363 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: 1 Month After End of Study Treatment	32.5 percentage of participants Interval 27.8 to 37.6	31.1 percentage of participants Interval 26.4 to 36.2

SECONDARY outcome

Timeframe: From start of treatment to approximately 4.5 months (3 months after the end of treatment)

Population: Eligible patients who started study treatment and had adverse events assessment at 3 months after treatment end

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=359 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=367 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: 3 Months After the End of Study Treatment	17.5 percentage of participants Interval 13.8 to 21.9	14.7 percentage of participants Interval 11.3 to 18.8

SECONDARY outcome

Timeframe: From start of treatment to approximately 7.5 months (6 months after the end of treatment)

Population: Eligible patients who started study treatment and had adverse events assessment at 6 months year after treatment end

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=361 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=352 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: 6 Months After the End of Study Treatment	13.3 percentage of participants Interval 10.0 to 17.2	9.4 percentage of participants Interval 6.5 to 12.9

SECONDARY outcome

Timeframe: From start of treatment to approximately 13.5 months (one year after the end of treatment)

Population: Eligible patients who started study treatment and had adverse events assessment at 1 year after treatment end

Late adverse events (AE) are defined as \> 180 days from end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=360 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=351 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Percentage of Participants With Late Grade 3-4 Treatment-related Adverse Events: 1 Year After the End of Study Treatment	10.0 percentage of participants Interval 7.1 to 13.6	8.5 percentage of participants Interval 5.8 to 12.0

SECONDARY outcome

Timeframe: From 180 days after end of treatment to two years after end of treatment.

Population: .Eligible patients who started study treatment and had adverse events assessment at 2 years after treatment end

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=311 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=303 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Percentage of Participants With Late Grade 3-4 Treatment-related Adverse Events: 2 Years After the End of Study Treatment	7.7 percentage of participants Interval 5.0 to 11.3	4.0 percentage of participants Interval 2.1 to 6.8

SECONDARY outcome

Timeframe: From start of treatment to approximately 61.5 months (five years after the end of treatment)

Population: Eligible patients who started study treatment and had adverse events assessment at 5 years after treatment end

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=92 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=86 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Percentage of Participants With Late Grade 3-4 Treatment-related Adverse Events: 5 Years After the End of Study Treatment	4.3 percentage of participants Interval 1.2 to 10.8	7.0 percentage of participants Interval 2.6 to 14.6

SECONDARY outcome

Timeframe: From randomization to 1 year.

Population: Eligible patients who started study treatment and had feeding tube assessment at 1 year

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=368 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=356 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Percentage of Participants With a Feeding Tube at 1 Year	9.2 percentage of participants Interval 6.5 to 12.7	8.4 percentage of participants Interval 5.8 to 11.8

SECONDARY outcome

Timeframe: Baseline and end of treatment (6-7 weeks)

Population: Eligible participants enrolled to the quality of life (QOL) substudy who received protocol treatment and had outcome measure data.

The EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30) Global Health Status score measures a cancer patient's perception of their overall health and well-being and ranges from 0 (worst) to 100 (best). A positive change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=131 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=133 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
EORTC QLQ-C30 Global Health Status Score Change From Baseline at End of Treatment	-23.16 score on a scale Standard Deviation 28.16	-25.31 score on a scale Standard Deviation 22.92

SECONDARY outcome

Timeframe: Baseline and 3 months from end of treatment. Treatment lasts 6-7 weeks.

Population: Eligible participants enrolled to the quality of life (QOL) substudy who received protocol treatment and had outcome measure data.

The EORTC QLQ-C30 Global Health Status score measures a cancer patient's perception of their overall health and well-being and ranges from 0 (worst) to 100 (best). A positive change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=130 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=132 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
EORTC QLQ-C30 Global Health Status Score Change From Baseline at 3 Months From End of Treatment	-4.42 score on a scale Standard Deviation 25.92	-7.51 score on a scale Standard Deviation 22.46

SECONDARY outcome

Timeframe: Baseline and 6 months from end of treatment. Treatment lasts 6-7 weeks.

Population: Eligible participants enrolled to the quality of life (QOL) substudy who received protocol treatment and had outcome measure data.

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=132 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=130 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
EORTC QLQ-C30 Global Health Status Score Change From Baseline at 6 Months From End of Treatment	-0.57 score on a scale Standard Deviation 25.01	-0.90 score on a scale Standard Deviation 23.35

SECONDARY outcome

Timeframe: Baseline and 12 months from end of treatment. Treatment lasts 6-7 weeks

Population: Eligible participants enrolled to the quality of life (QOL) substudy who received protocol treatment and had outcome measure data.

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=119 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=116 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
EORTC QLQ-C30 Global Health Status Score Change From Baseline at 12 Months From End of Treatment	3.15 score on a scale Standard Deviation 23.42	2.59 score on a scale Standard Deviation 21.09

SECONDARY outcome

Timeframe: Baseline and end of treatment (6-7 weeks)

Population: Eligible participants enrolled to the quality of life (QOL) substudy who received protocol treatment and had outcome measure data.

The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Head and Neck Cancer Module (EORTC QLQ-H\&N35) swallowing score measures patient-reported difficulty with swallowing various foods and liquid and ranges from 0 (no swallowing problems) to 100 (maximum swallowing difficulty). A positive change from baseline indicates worsening swallowing function.

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=131 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=132 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
EORTC QLQ-H&N35 Swallowing Score Change From Baseline at End of Treatment	47.99 score on a scale Standard Deviation 27.99	47.43 score on a scale Standard Deviation 24.52

SECONDARY outcome

Timeframe: Baseline and 3 months from end of treatment. Treatment lasts 6-7 weeks.

Population: Eligible participants enrolled to the quality of life (QOL) substudy who received protocol treatment and had outcome measure data.

The EORTC QLQ-H\&N35 swallowing score measures patient-reported difficulty with swallowing various foods and liquid and ranges from 0 (no swallowing problems) to 100 (maximum swallowing difficulty). A positive change from baseline indicates worsening swallowing function.

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=130 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=132 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
EORTC QLQ-H&N35 Swallowing Score Change From Baseline at 3 Months From End of Treatment.	10.58 score on a scale Standard Deviation 26.49	14.20 score on a scale Standard Deviation 20.61

SECONDARY outcome

Timeframe: Baseline and 6 months from end of treatment. Treatment lasts 6-7 weeks.

Population: Eligible participants enrolled to the quality of life (QOL) substudy who received protocol treatment and had outcome measure data.

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=132 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=130 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
EORTC QLQ-H&N35 Swallowing Score Change From Baseline at 6 Months From End of Treatment.	8.65 score on a scale Standard Deviation 23.94	10.13 score on a scale Standard Deviation 18.73

SECONDARY outcome

Timeframe: Baseline and 12 months from end of treatment. Treatment lasts 6-7 weeks.

Population: Eligible participants enrolled to the quality of life (QOL) substudy who received protocol treatment and had outcome measure data.

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=119 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=116 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
EORTC QLQ-H&N35 Swallowing Score Change From Baseline at 12 Months From End of Treatment.	2.52 score on a scale Standard Deviation 19.64	7.61 score on a scale Standard Deviation 17.81

SECONDARY outcome

Timeframe: From randomization to 1 year after end of treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From randomization to 1 year after end of treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From randomization to 1 year after end of treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before treatment

Population: Eligible patients who started study treatment

This study utilized a dental effects health scale from 0 (normal) to 4 (life-threatening dental condition). The percentage of participants with a value of 0 or 1 is reported: 0 = "Normal: Edentulous, with no gingival disease"; 1 = "Mild changes/good dental health: mild periodontal inflammation-routine cleaning indicated; \< 5 restorations indicated; no extractions indicated." Ten year data is not yet available.

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=398 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=394 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Percentage of Patients With Normal/Good Dental Health: Pretreatment	71.1 percentage of participants Interval 66.4 to 75.5	74.6 percentage of participants Interval 70.0 to 78.8

SECONDARY outcome

Timeframe: 1 year after end of treatment (approximately 13.5 months)

Population: Eligible patients who started study treatment and had dental status assessment at 1 year after treatment end

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=267 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=267 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Percentage of Patients With Normal/Good Dental Health: 1 Year After End of Treatment	87.3 percentage of participants Interval 82.7 to 91.0	83.5 percentage of participants Interval 78.5 to 87.8

SECONDARY outcome

Timeframe: 2 years after end of treatment (approximately 25.5 months)

Population: Eligible patients who started study treatment and had dental status assessment at 2 years after treatment end

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=208 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=201 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Percentage of Patients With Normal/Good Dental Health: 2 Years After End of Treatment	86.5 percentage of participants Interval 81.1 to 90.9	82.1 percentage of participants Interval 76.1 to 87.1

SECONDARY outcome

Timeframe: 5 years after end of treatment (approximately 61.5 months)

Population: Eligible patients who started study treatment and had dental status assessment at 5 years after treatment end

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=44 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=43 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Percentage of Patients With Normal/Good Dental Health: 5 Years After End of Treatment	88.6 percentage of participants Interval 75.4 to 96.2	86.0 percentage of participants Interval 72.1 to 94.7

SECONDARY outcome

Timeframe: 10 years after end of treatment (approximately 121.5 months)

Population: Eligible patients who started study treatment and had dental status assessment at 10 years after treatment end

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=34 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=25 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Percentage of Patients With Normal/Good Dental Health: 10 Years After End of Treatment	91.2 Percentage of participants Interval 76.3 to 98.1	84.0 Percentage of participants Interval 63.9 to 95.5

SECONDARY outcome

Timeframe: Baseline

Population: Eligible participants enrolled to the quality of life (QOL) substudy who received protocol treatment and had outcome measure data.

The Hearing Handicap Inventory for Adults Screen Version (HHIA-S) measures a person's perceived hearing handicap. Total score ranges from 0 to 40, with a higher score indicating more severe perceived hearing handicap, categorized as follows: * No handicap: 0-8. * Mild-moderate handicap: 10-24. * Severe handicap: 26-40.

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=175 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=171 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Number of Participants by HHIA-S Category at Baseline No handicap	150 Participants	132 Participants
Number of Participants by HHIA-S Category at Baseline Mild-moderate handicap	23 Participants	32 Participants
Number of Participants by HHIA-S Category at Baseline Severe handicap	2 Participants	7 Participants

SECONDARY outcome

Timeframe: End of treatment (6-7 weeks)

Population: Eligible participants enrolled to the quality of life (QOL) substudy who received protocol treatment and had outcome measure data.

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=134 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=133 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Number of Participants by HHIA-S Category at End of Treatment Severe handicap	14 Participants	5 Participants
Number of Participants by HHIA-S Category at End of Treatment No handicap	91 Participants	107 Participants
Number of Participants by HHIA-S Category at End of Treatment Mild-moderate handicap	29 Participants	21 Participants

SECONDARY outcome

Timeframe: 3 months after end of treatment. Treatment lasts 6-7 weeks.

Population: Eligible participants enrolled to the quality of life (QOL) substudy who received protocol treatment and had outcome measure data.

The HHIA-S measures a person's perceived hearing handicap. Total score ranges from 0 to 40, with a higher score indicating more severe perceived hearing handicap, categorized as follows: * No handicap: 0-8. * Mild-moderate handicap: 10-24. * Severe handicap: 26-40.

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=136 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=137 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Number of Participants by HHIA-S Category at 3 Months After End of Treatment No handicap	93 Participants	109 Participants
Number of Participants by HHIA-S Category at 3 Months After End of Treatment Mild-moderate handicap	28 Participants	21 Participants
Number of Participants by HHIA-S Category at 3 Months After End of Treatment Severe handicap	15 Participants	7 Participants

SECONDARY outcome

Timeframe: 6 months after end of treatment. Treatment lasts 6-7 weeks.

Population: Eligible participants enrolled to the quality of life (QOL) substudy who received protocol treatment and had outcome measure data.

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=140 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=131 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Number of Participants by HHIA-S Category at 6 Months After End of Treatment No handicap	95 Participants	106 Participants
Number of Participants by HHIA-S Category at 6 Months After End of Treatment Mild-moderate handicap	31 Participants	21 Participants
Number of Participants by HHIA-S Category at 6 Months After End of Treatment Severe handicap	14 Participants	4 Participants

SECONDARY outcome

Timeframe: 12 months after end of treatment. Treatment lasts 6-7 weeks.

Population: Eligible participants enrolled to the quality of life (QOL) substudy who received protocol treatment and had outcome measure data.

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=121 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=125 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Number of Participants by HHIA-S Category at 12 Months After End of Treatment No handicap	84 Participants	103 Participants
Number of Participants by HHIA-S Category at 12 Months After End of Treatment Mild-moderate handicap	27 Participants	17 Participants
Number of Participants by HHIA-S Category at 12 Months After End of Treatment Severe handicap	10 Participants	5 Participants

SECONDARY outcome

Timeframe: From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 214 deaths were reported. Median follow-up at time of analysis was 8.3 years.

Population: Eligible participants with KRAS data

KRAS (Kirsten Rat Sarcoma Viral Oncogene Homolog) is a gene that helps control how cells grow. Some people have a change in this gene, which can be detected (variant/non-variant) by a genetic test performed on tissue from their tumor. Research suggests that this change may influence how head and neck cancer responds to certain treatments. An event for overall survival is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is hazard ratio, which is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=92 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=470 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Overall Survival by KRAS (Kirsten Rat Sarcoma Viral Oncogene Homolog) Variant Status	80.6 percentage of participants Interval 72.3 to 88.9	79.2 percentage of participants Interval 75.4 to 83.0

SECONDARY outcome

Population: Eligible participants with KRAS data

KRAS (Kirsten Rat Sarcoma Viral Oncogene Homolog) is a gene that helps control how cells grow. Some people have a change in this gene, which can be detected (variant/non-variant) by a genetic test performed on tissue from their tumor. Research suggests that this change may influence how head and neck cancer responds to certain treatments. An event for progression-free survival is local, regional, or distant disease progression or death due to any cause. Progression-free survival time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is the distribution of progression-free survival times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=92 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=470 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Progression-free Survival by KRAS Variant Status	72.0 percentage of participants Interval 62.6 to 81.3	71.5 percentage of participants Interval 67.3 to 75.7

SECONDARY outcome

Population: Eligible participants with KRAS data

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=275 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=287 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Overall Survival by Treatment Arm Within KRAS Variant Status Group Variant	83.3 percentage of participants Interval 72.0 to 94.6	78.4 percentage of participants Interval 66.5 to 90.3
Overall Survival by Treatment Arm Within KRAS Variant Status Group Non-variant	80.8 percentage of participants Interval 75.6 to 86.1	77.6 percentage of participants Interval 72.2 to 83.1

SECONDARY outcome

Population: Eligible participants with KRAS data

KRAS (Kirsten Rat Sarcoma Viral Oncogene Homolog) is a gene that helps control how cells grow. Some people have a change in this gene, which can be detected (variant/non-variant) by a genetic test performed on tissue from their tumor. Research suggests that this change may influence how head and neck cancer responds to certain treatments. An event for progression-free survival is local, regional, or distant disease progression or death due to any cause. Progression-free survival time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is the distribution of progression-free survival times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=275 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=287 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Progression-free Survival Within KRAS Variant Status Variant	76.6 percentage of participants Interval 63.9 to 89.3	67.7 percentage of participants Interval 54.2 to 81.2
Progression-free Survival Within KRAS Variant Status Non-variant	75.1 percentage of participants Interval 69.4 to 80.8	68.0 percentage of participants Interval 62.0 to 74.1

OTHER_PRE_SPECIFIED outcome

Population: Eligible participants. Data were stratified by sex.

NIH-required analysis. An event for overall survival is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is hazard ratio, which is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=406 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=399 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Overall Survival by Sex Female	93.4 percentage of participants Interval 84.6 to 100.0	76.8 percentage of participants Interval 62.8 to 90.8
Overall Survival by Sex Male	83.8 percentage of participants Interval 79.6 to 88.1	78.0 percentage of participants Interval 73.2 to 82.9

OTHER_PRE_SPECIFIED outcome

Population: Eligible participants. Data were stratified by ethnicity.

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=406 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=399 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Overall Survival by Ethnicity Hispanic or Latino	100 percentage of participants SAS software does not compute a confidence interval when the estimate is 100%.	70.7 percentage of participants Interval 46.5 to 95.0
Overall Survival by Ethnicity Not Hispanic or Latino	84.7 percentage of participants Interval 80.6 to 88.8	77.9 percentage of participants Interval 73.2 to 82.7
Overall Survival by Ethnicity Unknown or Not Reported	66.8 percentage of participants Interval 35.1 to 98.6	85.7 percentage of participants Interval 67.4 to 100.0

OTHER_PRE_SPECIFIED outcome

Population: Eligible participants. Data were stratified by ethnicity.

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin n=406 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.	IMRT + Cetuximab n=399 Participants Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Overall Survival by Race American Indian or Alaska Native	—	100 percentage of participants SAS software does not compute a confidence interval when the estimate is 100%.
Overall Survival by Race Asian	NA percentage of participants Cannot be calculated because participants was censored prior to the timepoint.	100 percentage of participants SAS software does not compute a confidence interval when the estimate is 100%
Overall Survival by Race Native Hawaiian or Other Pacific Islander	—	NA percentage of participants Cannot be calculated because participants were censored prior to the timepoint.
Overall Survival by Race Black or African American	77.5 percentage of participants Interval 54.9 to 100.0	76.4 percentage of participants Interval 55.9 to 96.9
Overall Survival by Race White	84.6 percentage of participants Interval 80.5 to 88.7	77.3 percentage of participants Interval 72.5 to 82.1
Overall Survival by Race More than one race	—	NA percentage of participants Cannot be calculated because participants were censored prior to the timepoint.
Overall Survival by Race Unknown or Not Reported	100 percentage of participants SAS software does not compute a confidence interval when the estimate is 100%.	100 percentage of participants SAS software does not compute a confidence interval when the estimate is 100%.

Adverse Events

IMRT + Cisplatin

Serious events: 177 serious events

Other events: 398 other events

Deaths: 64 deaths

IMRT + Cetuximab

Serious events: 115 serious events

Other events: 393 other events

Deaths: 86 deaths

Serious adverse events

Other adverse events

Additional Information

Wendy Seiferheld

NRG Oncology

Phone: 215-574-3208

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
Publication restrictions are in place

Restriction type: OTHER