Trial · NCT00047008

Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Head and Neck Cancer

NCT00047008, Phase 3, Completed, Radiation Therapy Oncology Group; results first posted 2014-08-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Head and Neck Cancer. Trials, record NCT00047008. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00047008

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Head and Neck Cancer
NCT number: NCT00047008
Status: Completed
Phases: Phase 3
Enrollment: 743 participants, actual
Lead sponsor: Radiation Therapy Oncology Group
Conditions: Head and Neck Cancer
Interventions: cisplatin, Standard fractionation RT, Accelerated fractionation radiation therapy, Conventional surgery for select patients
First posted: 2003-01-27
Last updated: 2023-07-07
Results first posted: 2014-08-15
Limitations and caveats: Local-regional failure and disease-free survival were additionally analyzed with the definition of failure used in the Meta-Analysis of Radiotherapy in Carcinomas of Head and Neck (MARCH) Collaborative Group and the Meta-Analysis of Chemotherapy in Head and Neck Cancer (MACH-NC) Collaborative Group publications. These modified outcome measures are labeled Alternate Definition.

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Survival (Percentage of Participants Alive)	From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.	Overall survival time is defined as time from randomization to the date of death (failure) or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported.
Secondary	Local-regional Failure (Percentage of Participants With Local-regional Failure)	From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.	Local-regional failure time is defined as time from randomization to persistent disease in the primary tumor or regional nodes (considered an event at day 1), relapse/progression in either of those sites (considered an event at the time of relapse/progression), death (competing event), or last follow-up (censored). Progression is defined as an estimated increase in the size of the tumor of greater than 25% or appearance of new areas of malignant disease. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported.
Secondary	Local-regional Failure (Alternate Definition) [Percentage of Participants With Local-regional Failure]	From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.	Local-regional failure time is defined as time from randomization to relapse/progression in the primary tumor or regional nodes (event), death due to study cancer or unknown causes (event), death due to other causes (competing event), distant metastasis (competing event), or last follow-up (censored). Progression is defined as an estimated increase in the size of the tumor of greater than 25% or appearance of new areas of malignant disease. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported.
Secondary	Disease-free Survival (Percentage of Participants Alive Without Disease)	From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.	Disease-free survival time is defined as time from randomization to persistent disease in the primary tumor or regional nodes (considered an event at day 1), relapse/progression in either of those sites (considered an event at the time of relapse/progression), distant metastasis (event), second primary tumor (event), death (event), or last follow-up (censored). Progression is defined as an estimated increase in the size of the tumor of greater than 25% or appearance of new areas of malignant disease. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported.
Secondary	Progression-free Survival (Alternate Definition of Disease-free Survival) [Percentage of Participants Alive Without Progression]	From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.	Progression-free survival time is defined as time from randomization to relapse/progression in the primary site or regional nodes (event), distant metastasis (event), death (event), or last follow-up (censored). Progression is defined as an estimated increase in the size of the tumor of greater than 25% or appearance of new areas of malignant disease. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported.
Secondary	Percentage of Participants With Toxicity Grade 3 or Higher	From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years.	Acute radiation therapy toxicities (within 90 days from start of radiation therapy) and systemic effects at any time were scored using Common Toxicity Criteria (CTC) version 2.0. Late RT toxicities (\> 90 days from start of radiation therapy) were scored by the Radiation Therapy Oncology Group (RTOG)/European Organisation for. Research and Treatment of Cancer (EORTC) criteria. Both criteria grades toxicity severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event/toxicity data.
Secondary	Performance Status Scale for Head and Neck Cancer (PSS-HN) Normalcy of Diet Score - Area Under the Curve (AUC) at One Year	Baseline (pretreatment), sometime during the last two weeks of treatment, three months from start of treatment, and one year from start of treatment.	The PSS-HN is a clinician-rated evaluation conducted as an unstructured interview format that assesses three functions: Normalcy of Diet (this outcome measure), Public Eating, and Understandability of Speech. Each function is scored from 0 to 100 and analyzed separately. Higher scores indicate better performance status. Treatment effect was analyzed as time-weighted average between baseline (pre-treatment) and one year calculated by use of area under the curve (AUC).
Secondary	PSS-HN Public Eating Score - AUC at One Year	Baseline (pretreatment), sometime during the last two weeks of treatment, three months from start of treatment, and one year from start of treatment.	The Performance Status Scale for Head and Neck Cancer (PSS-HN) is a clinician-rated evaluation conducted as an unstructured interview format that assesses three functions: Normalcy of Diet , Public Eating (this outcome measure), and Understandability of Speech. Each function is scored from 0 to 100 and analyzed separately. Higher scores indicate better performance status. Treatment effect was analyzed as time-weighted average between baseline (pretreatment) and one year calculated by use of area under the curve (AUC).
Secondary	PSS-HN Understandability of Speech Score - AUC at One Year	Baseline (pretreatment), sometime during the last two weeks of treatment, three months from start of treatment, and one year from start of treatment.	The Performance Status Scale for Head and Neck Cancer (PSS-HN) is a clinician-rated evaluation conducted as an unstructured interview format that assesses three functions: Normalcy of Diet , Public Eating, and Understandability of Speech (this outcome measure). Each function is scored from 0 to 100 and analyzed separately. Higher scores indicate better performance status. Treatment effect was analyzed as time-weighted average between baseline (pretreatment) and one year calculated by use of area under the curve (AUC).
Secondary	Head and Neck Radiotherapy Questionnaire (HNRQ) - AUC at One Year	Baseline (pretreatment), sometime during the last two weeks of treatment, three months from start of treatment, and one year from start of treatment.	The HNRQ is a patient-reported questionnaire administrated through a paper format; it measures radiation-related side effects and the overall well-being of head and neck cancer patients in the past week. The overall score is the mean of the 22 questions, with a range of 1 to 7. Higher scores indicate better quality of life. Treatment effect was analyzed as time-weighted average between baseline (pre-treatment) and 1 year calculated by use of area under the curve (AUC).

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival (Percentage of Participants Alive)	From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.	Eligible patients who did not withdraw consent.	percentage of patients	NUMBER
SECONDARY	Local-regional Failure (Percentage of Participants With Local-regional Failure)	From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.	Eligible patients who did not withdraw consent	percentage of participants	NUMBER
SECONDARY	Local-regional Failure (Alternate Definition) [Percentage of Participants With Local-regional Failure]	From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.	Eligible patients who did not withdraw consent	percentage of participants	NUMBER
SECONDARY	Disease-free Survival (Percentage of Participants Alive Without Disease)	From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.	Eligible patients who did not withdraw consent	percentage of participants	NUMBER
SECONDARY	Progression-free Survival (Alternate Definition of Disease-free Survival) [Percentage of Participants Alive Without Progression]	From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.	Eligible patients who did not withdraw consent	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Toxicity Grade 3 or Higher	From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years.	Eligible patients who did not withdraw consent	percentage of participants	NUMBER
SECONDARY	Performance Status Scale for Head and Neck Cancer (PSS-HN) Normalcy of Diet Score - Area Under the Curve (AUC) at One Year	Baseline (pretreatment), sometime during the last two weeks of treatment, three months from start of treatment, and one year from start of treatment.	Eligible patients who did not withdraw consent, with all 4 assessments: baseline, last 2 weeks of treatment, 3 months, and 12 months.	score on a scale * months	MEAN
SECONDARY	PSS-HN Public Eating Score - AUC at One Year	Baseline (pretreatment), sometime during the last two weeks of treatment, three months from start of treatment, and one year from start of treatment.	Eligible patients who did not withdraw consent, with all 4 assessments: baseline, last 2 weeks of treatment, 3 months, and 12 months.	score on a scale * months	MEAN
SECONDARY	PSS-HN Understandability of Speech Score - AUC at One Year	Baseline (pretreatment), sometime during the last two weeks of treatment, three months from start of treatment, and one year from start of treatment.	Eligible patients who did not withdraw consent, with all 4 assessments: baseline, last 2 weeks of treatment, 3 months, and 12 months.	score on a scale * months	MEAN
SECONDARY	Head and Neck Radiotherapy Questionnaire (HNRQ) - AUC at One Year	Baseline (pretreatment), sometime during the last two weeks of treatment, three months from start of treatment, and one year from start of treatment.	Eligible participants who did not withdraw consent, with all 4 assessments: baseline, last 2 weeks of treatment, 3 months, and one year.	score on a scale * months	MEAN

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group22

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Overall Survival (Percentage of Participants Alive)	Standard Fractionation RT + Cisplatin	64.3	95% Confidence Interval 59.3 to 69.2	percentage of patients
Overall Survival (Percentage of Participants Alive)	Accelerated Fractionation RT + Cisplatin	70.3	95% Confidence Interval 65.6 to 75.1	percentage of patients
Local-regional Failure (Percentage of Participants With Local-regional Failure)	Standard Fractionation RT + Cisplatin	25.5	95% Confidence Interval 21.0 to 30.0	percentage of participants
Local-regional Failure (Percentage of Participants With Local-regional Failure)	Accelerated Fractionation RT + Cisplatin	28.7	95% Confidence Interval 24.0 to 33.4	percentage of participants
Local-regional Failure (Alternate Definition) [Percentage of Participants With Local-regional Failure]	Standard Fractionation RT + Cisplatin	25.6	95% Confidence Interval 21.1 to 30.1	percentage of participants
Local-regional Failure (Alternate Definition) [Percentage of Participants With Local-regional Failure]	Accelerated Fractionation RT + Cisplatin	28.2	95% Confidence Interval 23.6 to 32.9	percentage of participants
Disease-free Survival (Percentage of Participants Alive Without Disease)	Standard Fractionation RT + Cisplatin	51.4	95% Confidence Interval 46.3 to 56.6	percentage of participants
Disease-free Survival (Percentage of Participants Alive Without Disease)	Accelerated Fractionation RT + Cisplatin	53.4	95% Confidence Interval 48.2 to 58.6	percentage of participants
Progression-free Survival (Alternate Definition of Disease-free Survival) [Percentage of Participants Alive Without Progression]	Standard Fractionation RT + Cisplatin	55.8	95% Confidence Interval 50.6 to 60.9	percentage of participants
Progression-free Survival (Alternate Definition of Disease-free Survival) [Percentage of Participants Alive Without Progression]	Accelerated Fractionation RT + Cisplatin	57.0	95% Confidence Interval 51.8 to 62.1	percentage of participants

1 to 10 of 22Source ClinicalTrials.gov

See all 22 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Standard Fractionation RT + Cisplatin	372
Overall Study	STARTED	Accelerated Fractionation RT + Cisplatin	371
Overall Study	COMPLETED	Standard Fractionation RT + Cisplatin	361
Overall Study	COMPLETED	Accelerated Fractionation RT + Cisplatin	360
Overall Study	NOT COMPLETED	Standard Fractionation RT + Cisplatin	11
Overall Study	NOT COMPLETED	Accelerated Fractionation RT + Cisplatin	11

Source ClinicalTrials.gov

Adverse events332

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Hemoglobin decreased	Blood and lymphatic system disorders	Standard Fractionation RT + Cisplatin	325	361
other	Hemoglobin decreased	Blood and lymphatic system disorders	Accelerated Fractionation RT + Cisplatin	301	360
other	Hearing impaired	Ear and labyrinth disorders	Standard Fractionation RT + Cisplatin	63	361
other	Hearing impaired	Ear and labyrinth disorders	Accelerated Fractionation RT + Cisplatin	35	360
other	Hearing-Other	Ear and labyrinth disorders	Standard Fractionation RT + Cisplatin	52	361
other	Hearing-Other	Ear and labyrinth disorders	Accelerated Fractionation RT + Cisplatin	53	360
other	Constipation	Gastrointestinal disorders	Standard Fractionation RT + Cisplatin	73	361
other	Constipation	Gastrointestinal disorders	Accelerated Fractionation RT + Cisplatin	54	360
other	Diarrhea NOS	Gastrointestinal disorders	Standard Fractionation RT + Cisplatin	37	361
other	Diarrhea NOS	Gastrointestinal disorders	Accelerated Fractionation RT + Cisplatin	27	360

1 to 10 of 332Source ClinicalTrials.gov

See all 332 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Standard Fractionation RT + Cisplatin
Total, all-cause mortality	Accelerated Fractionation RT + Cisplatin
Total, other adverse events	Standard Fractionation RT + Cisplatin	360	361
Total, other adverse events	Accelerated Fractionation RT + Cisplatin	356	360
Total, serious adverse events	Standard Fractionation RT + Cisplatin	293	361
Total, serious adverse events	Accelerated Fractionation RT + Cisplatin	279	360

Source ClinicalTrials.gov

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
20530316	RESULT	PubMed
22565003	BACKGROUND	PubMed
25366680	DERIVED	PubMed
25488965	DERIVED	PubMed
30548235	DERIVED	PubMed
31420360	DERIVED	PubMed
41343184	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Standard Fractionation RT + Cisplatin vs Accelerated Fractionation RT + Cisplatin: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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