Trial · NCT00265941
Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With Stage III or Stage IV Head and Neck Cancer
NCT00265941, Phase 3, Completed, Radiation Therapy Oncology Group; results first posted 2017-12-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With Stage III or Stage IV Head and Neck Cancer. Trials, record NCT00265941. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00265941
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With Stage III or Stage IV Head and Neck Cancer
- NCT number
- NCT00265941
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 940 participants, actual
- Lead sponsor
- Radiation Therapy Oncology Group
- Conditions
- Head and Neck Cancer
- Interventions
- cetuximab, cisplatin, Accelerated Fractionation by Concomitant Boost, Intensity-modulated radiation therapy
- First posted
- 2005-12-15
- Last updated
- 2022-06-14
- Results first posted
- 2017-12-21
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) (3-year Rate Reported) | From randomization until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.) | Progression-free survival (PFS) is defined as time from randomization to date of local, regional, or distant disease progression, or death from any cause. Patients last known to be alive without progression are censored at the date of last contact. Three-year rates were estimated by the Kaplan-Meier method. Local or regional progression is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. Distant progression is defined as clear evidence of distant metastases. |
| Secondary | Overall Survival (OS) (3-year Rate Reported) | From randomization until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.) | Overall survival is defined as time from randomization to date of death from any cause. Patients last known to be alive are censored at the date of last contact. Three-year rates were estimated by the Kaplan-Meier method. |
| Secondary | Local-regional Failure (LRF) (3-year Rate Reported) | From randomization until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.) | Local-regional failure is defined as time from randomization to date of failure (local or regional progression), or distant disease progression, or death from any cause. Patients last known to be alive without progression are censored at the date of last contact. Distant disease progression is considered a competing risk. Local or regional progression is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. Distant progression is defined as clear evidence of distant metastases. Three-year rates were estimated by the cumulative incidence method. |
| Secondary | Rate of Mucositis Toxicity ≥ Grade 3 | From start of treatment until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.) | Grade 3 or higher Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 radiation mucositis definitely, probably, or possibly related to protocol treatment. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. |
| Secondary | Rate of Other Toxicity ≥ Grade 3 (Not Mucositis) | From start of treatment until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.) | Grade 3 or higher Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 other than radiation mucositis definitely, probably, or possibly related to protocol treatment. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. |
| Secondary | Rate of Patients Who Tolerated Treatment | From start of treatment to end of treatment (6-7 weeks) | A patient was considered to have tolerated treatment if radiation therapy was scored as per protocol or with acceptable variation, they received 2 cycles of cisplatin, and for arm 2, they received the initial dose of cetuximab and at least 5 weekly doses of cetuximab . |
| Secondary | Rate of Deaths ≤ 30 Days After Discontinuation of Protocol Treatment | From start of treatment to 30 days after the end of treatment | Patients who died during treatment or within 30 days after the end of treatment |
| Secondary | Quality of Life as Measured by European Quality of Life Questionnaire (EQ-5D) | 3 months and 12 months | The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). Health states are defined by the combination of the leveled responses to the 5 dimensions, generating 243 health states to which unconsciousness and death are added. The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Both the 5-item index score and the VAS score are transformed into a utility score between 0 (worst health state) and 1 (best health state). |
| Secondary | Quality of Life as Measured by Proportion of Patients With Performance Status Scale for Head and Neck Cancer (PSS-HN) Scores ≤ 50 | 3 months and 12 months | The PSS-HN is a clinician rated instrument consisting of assessment of three functions (subscales): Normalcy of Diet, Eating in Public, and Understandability of Speech. The interviewer rates the patient on each scale based on the patient's responses to targeted questions. Scores on each subscale range from 0-100, with higher scores indicating better performance. It has been demonstrated to be reliable and valid in head and neck cancer patients.The site research nurse or clinical research associate (CRA) will determine the score on each of the subscales by performing a clinical evaluation and unstructured interview format. The PSS-HN takes approximately 5 minutes to complete. |
| Secondary | Quality of Life as Measured by Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-HN) at 12 Months | Baseline and 12 months | The Functional Assessment of Cancer Therapy-Head and Neck (FACT-HN) is a 10-item self-report instrument designed to measure multidimensional quality of life in patients with head and neck cancer. It is to be administered with the FACT-General. There are 5 responses options, with 0=Not a lot and 4=Very much. All items are added together to obtain a total score which ranges from 0-40. Certain items must be reversed before it is added by subtracting the response from 4. It requires at least 50% of the items to be completed while the overall response rate of the FACT-HN including the FACT-G must be greater than 80%. If items are missing, the subscale scores can be prorated. A higher score indicated better QOL. Change from baseline to 12 months (12 months - baseline) is reported. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) (3-year Rate Reported) | From randomization until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.) | Randomized eligible patients with follow-up data | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) (3-year Rate Reported) | From randomization until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.) | Randomized eligible patients with follow-up data | percentage of participants | NUMBER |
| SECONDARY | Local-regional Failure (LRF) (3-year Rate Reported) | From randomization until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.) | Randomized eligible patients with follow-up data | percentage of participants | NUMBER |
| SECONDARY | Rate of Mucositis Toxicity ≥ Grade 3 | From start of treatment until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.) | Randomized eligible patients with follow-up data | percentage of participants | NUMBER |
| SECONDARY | Rate of Other Toxicity ≥ Grade 3 (Not Mucositis) | From start of treatment until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.) | Randomized eligible patients with follow-up data | percentage of participants | NUMBER |
| SECONDARY | Rate of Patients Who Tolerated Treatment | From start of treatment to end of treatment (6-7 weeks) | Randomized eligible patients with follow-up data | percentage of participants | NUMBER |
| SECONDARY | Rate of Deaths ≤ 30 Days After Discontinuation of Protocol Treatment | From start of treatment to 30 days after the end of treatment | Randomized eligible patients with follow-up data | percentage of participants | NUMBER |
| SECONDARY | Quality of Life as Measured by European Quality of Life Questionnaire (EQ-5D) | 3 months and 12 months | Randomized eligible patients with EQ-5D data at the given time point. | units on a scale | MEAN |
| SECONDARY | Quality of Life as Measured by Proportion of Patients With Performance Status Scale for Head and Neck Cancer (PSS-HN) Scores ≤ 50 | 3 months and 12 months | Randomized eligible patients with PSS-HN data at the given time point. | proportion of participants | NUMBER |
| SECONDARY | Quality of Life as Measured by Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-HN) at 12 Months | Baseline and 12 months | Randomized eligible patients with baseline and 12-month FACT-HN data. | units on a scale | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) (3-year Rate Reported) | RT + Cisplatin | 61.2 | 95% Confidence Interval 56.7 to 65.8 | percentage of participants | |
| Progression-free Survival (PFS) (3-year Rate Reported) | RT + Cisplatin + Cetuximab | 58.9 | 95% Confidence Interval 54.2 to 63.6 | percentage of participants | |
| Overall Survival (OS) (3-year Rate Reported) | RT + Cisplatin | 72.9 | 95% Confidence Interval 68.7 to 77.1 | percentage of participants | |
| Overall Survival (OS) (3-year Rate Reported) | RT + Cisplatin + Cetuximab | 75.8 | 95% Confidence Interval 71.7 to 79.9 | percentage of participants | |
| Local-regional Failure (LRF) (3-year Rate Reported) | RT + Cisplatin | 19.9 | 95% Confidence Interval 16.2 to 23.7 | percentage of participants | |
| Local-regional Failure (LRF) (3-year Rate Reported) | RT + Cisplatin + Cetuximab | 25.9 | 95% Confidence Interval 21.7 to 30.1 | percentage of participants | |
| Rate of Mucositis Toxicity ≥ Grade 3 | RT + Cisplatin | 33.3 | 95% Confidence Interval 29.0 to 37.7 | percentage of participants | |
| Rate of Mucositis Toxicity ≥ Grade 3 | RT + Cisplatin + Cetuximab | 43.2 | 95% Confidence Interval 38.6 to 47.9 | percentage of participants | |
| Rate of Other Toxicity ≥ Grade 3 (Not Mucositis) | RT + Cisplatin | 89.3 | 95% Confidence Interval 86.4 to 92.1 | percentage of participants | |
| Rate of Other Toxicity ≥ Grade 3 (Not Mucositis) | RT + Cisplatin + Cetuximab | 91.9 | 95% Confidence Interval 89.4 to 94.4 | percentage of participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | RT + Cisplatin | 470 | |
| Overall Study | STARTED | RT + Cisplatin + Cetuximab | 470 | |
| Overall Study | COMPLETED | RT + Cisplatin | 447 | |
| Overall Study | COMPLETED | RT + Cisplatin + Cetuximab | 444 | |
| Overall Study | NOT COMPLETED | RT + Cisplatin | 23 | |
| Overall Study | NOT COMPLETED | RT + Cisplatin + Cetuximab | 26 |
Source ClinicalTrials.gov
Adverse events682
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 | Events |
|---|---|---|---|---|---|---|
| other | Blood/bone marrow - Other | Blood and lymphatic system disorders | RT + Cisplatin | 31 | 447 | |
| other | Blood/bone marrow - Other | Blood and lymphatic system disorders | RT + Cisplatin + Cetuximab | 31 | 444 | |
| other | Hemoglobin | Blood and lymphatic system disorders | RT + Cisplatin | 262 | 447 | |
| other | Hemoglobin | Blood and lymphatic system disorders | RT + Cisplatin + Cetuximab | 250 | 444 | |
| other | Ear pain | Ear and labyrinth disorders | RT + Cisplatin | 35 | 447 | |
| other | Ear pain | Ear and labyrinth disorders | RT + Cisplatin + Cetuximab | 33 | 444 | |
| other | Hearing impaired | Ear and labyrinth disorders | RT + Cisplatin | 127 | 447 | |
| other | Hearing impaired | Ear and labyrinth disorders | RT + Cisplatin + Cetuximab | 114 | 444 | |
| other | Tinnitus | Ear and labyrinth disorders | RT + Cisplatin | 117 | 447 | |
| other | Tinnitus | Ear and labyrinth disorders | RT + Cisplatin + Cetuximab | 106 | 444 |
1 to 10 of 682Source ClinicalTrials.gov
See all 682 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | RT + Cisplatin | ||
| Total, all-cause mortality | RT + Cisplatin + Cetuximab | ||
| Total, other adverse events | RT + Cisplatin | 442 | 447 |
| Total, other adverse events | RT + Cisplatin + Cetuximab | 433 | 444 |
| Total, serious adverse events | RT + Cisplatin | 208 | 447 |
| Total, serious adverse events | RT + Cisplatin + Cetuximab | 237 | 444 |
Source ClinicalTrials.gov
Papers8
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|
| RT + Cisplatin vs RT + Cisplatin + Cetuximab: 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.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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