Trial · NCT00956007
RT With or Without Cetuximab in Treating Patients Who Have Undergone Surgery for Locally Advanced Head and Neck Cancer
NCT00956007, Phase 3, Active not recruiting, Radiation Therapy Oncology Group; results first posted 2024-05-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. RT With or Without Cetuximab in Treating Patients Who Have Undergone Surgery for Locally Advanced Head and Neck Cancer. Trials, record NCT00956007. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00956007
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- RT With or Without Cetuximab in Treating Patients Who Have Undergone Surgery for Locally Advanced Head and Neck Cancer
- NCT number
- NCT00956007
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 702 participants, actual
- Lead sponsor
- Radiation Therapy Oncology Group
- Conditions
- Head and Neck Cancer
- Interventions
- cetuximab, intensity-modulated radiation therapy
- First posted
- 2009-08-11
- Last updated
- 2026-01-06
- Results first posted
- 2024-05-28
- Limitations and caveats
- Due to a lower-than-expected death rate, the statistical design was modified to perform the primary analysis after all randomized patients had a minimum of 5 years of potential follow-up.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Alive (Overall Survival) | From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years. | Overall survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. Analysis occurred after all participants had potentially been on study for at least 5 years. The distributions of survival times are compared, which is reported in the statistical analysis results. Five-year rates are provided. |
| Secondary | Percentage of Participants With ≥ Grade 3 Acute Dysphagia, Dry Mouth, or Skin Toxicity Related to Protocol Treatment | From start of radiation therapy to 90 days | Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Adverse events (AEs) assessed to be definitely, probably, or possibly related to protocol treatment were included. If relationship was missing, it was assumed to be definitely, probably, or possibly related to protocol treatment. Acute adverse events are those occurring within 90 days of the start of radiation therapy. |
| Secondary | Percentage of Participants With Other ≥ Grade 3 Adverse Events Related to Protocol Treatment | From start of radiation therapy to 90 days. | Adverse events other than dysphagia, dermatitis radiation, and rash acneiform. Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Adverse events (AEs) assessed to be definitely, probably, or possibly related to protocol treatment were included. If relationship was missing, it was assumed to be definitely, probably, or possibly related to protocol treatment. Acute adverse events are those occurring within 90 days of the start of radiation therapy. |
| Secondary | Percentage of Participants With ≥ Grade 3 Late Dysphagia, Dry Mouth, or Skin Toxicity Related to Protocol Treatment | From 91 days after start of radiation therapy to date of last reported follow-up. Maximum follow-up at time of analysis was 12.1 years. | Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Adverse events assessed to be definitely, probably, or possibly related to protocol treatment were included. If relationship was missing, it was assumed to be definitely, probably, or possibly related to protocol treatment. Late adverse events are those occurring after days from the start of radiation therapy. |
| Secondary | Percentage of Participants With Other ≥ Grade 3 Late Adverse Events Related to Protocol Treatment | From 91 days after start of radiation therapy to date of last reported follow-up. Maximum follow-up at time of analysis was 12.1 years. | Adverse events other than dysphagia, dermatitis radiation, and rash acneiform. Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Adverse events (AEs) assessed to be definitely, probably, or possibly related to protocol treatment were included. If relationship was missing, it was assumed to be definitely, probably, or possibly related to protocol treatment. Late adverse events are those occurring after days from the start of radiation therapy. |
| Secondary | Disease-free Survival | From randomization to date of LRR, DM, death or last known follow-up, whichever occurred first. Maximum follow-up at time of analysis was 12.1 years. | Disease is defined as local-regional progression/recurrence (LRR) or distant metastasis (DM). LRR is defined as recurrent cancer in the tumor bed and/or neck not clearly attributable to a second primary neoplasm; both imaging and biopsy confirmation are strongly recommended. DM is defined as clear evidence of distant metastases; biopsy is recommended where possible. Disease-free survival time is defined as time from randomization to the date of first disease, death, or last known follow-up (censored), whichever occurred first. Disease-free survival rates are estimated using the Kaplan-Meier method. Analysis occurred after all participants had potentially been on study for at least 5 years. The distributions of disease-free survival times are compared, which is reported in the statistical analysis results. Five-year rates are provided. |
| Other | Xerostomia as Measured by University of Michigan Xerostomia-Related Quality of Life Scale (XeQOLS) at Baseline and at 3, 12, and 24 Months | From randomization to 2 years. | |
| Other | Swallowing as Measured by the Normalcy of Diet Subscale of the Performance Status Scale for Head and Neck Cancer (PSS-HN) at Baseline and at 3, 12, and 24 Months | From randomization to 2 years. | |
| Other | Skin Toxicity as Measured by the Dermatology Life Quality Index (DLQI) at Baseline and at 3, 12, and 24 Months | From randomization to 2 years. | |
| Other | Quality of Life as Measured by Functional Assessment of Cancer Therapy-Head & Neck (FACT-HN) and EuroQol (EQ-5D) at Baseline and at 3, 12, and 24 Months | From randomization to 2 years. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Alive (Overall Survival) | From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years. | Randomized eligible participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With ≥ Grade 3 Acute Dysphagia, Dry Mouth, or Skin Toxicity Related to Protocol Treatment | From start of radiation therapy to 90 days | Randomized eligible participants who started protocol treatment | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Other ≥ Grade 3 Adverse Events Related to Protocol Treatment | From start of radiation therapy to 90 days. | Randomized eligible participants who started protocol treatment | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With ≥ Grade 3 Late Dysphagia, Dry Mouth, or Skin Toxicity Related to Protocol Treatment | From 91 days after start of radiation therapy to date of last reported follow-up. Maximum follow-up at time of analysis was 12.1 years. | Randomized eligible participants who started protocol treatment and had follow-up data at or after day 91 from start of radiation therapy | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Other ≥ Grade 3 Late Adverse Events Related to Protocol Treatment | From 91 days after start of radiation therapy to date of last reported follow-up. Maximum follow-up at time of analysis was 12.1 years. | Randomized eligible participants who started protocol treatment and had follow-up data at or after day 91 from start of radiation therapy | percentage of participants | NUMBER |
| SECONDARY | Disease-free Survival | From randomization to date of LRR, DM, death or last known follow-up, whichever occurred first. Maximum follow-up at time of analysis was 12.1 years. | Randomized eligible participants | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Xerostomia as Measured by University of Michigan Xerostomia-Related Quality of Life Scale (XeQOLS) at Baseline and at 3, 12, and 24 Months | From randomization to 2 years. | |||
| OTHER_PRE_SPECIFIED | Swallowing as Measured by the Normalcy of Diet Subscale of the Performance Status Scale for Head and Neck Cancer (PSS-HN) at Baseline and at 3, 12, and 24 Months | From randomization to 2 years. | |||
| OTHER_PRE_SPECIFIED | Skin Toxicity as Measured by the Dermatology Life Quality Index (DLQI) at Baseline and at 3, 12, and 24 Months | From randomization to 2 years. | |||
| OTHER_PRE_SPECIFIED | Quality of Life as Measured by Functional Assessment of Cancer Therapy-Head & Neck (FACT-HN) and EuroQol (EQ-5D) at Baseline and at 3, 12, and 24 Months | From randomization to 2 years. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group45
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Alive (Overall Survival) | IMRT | 68.7 | 95% Confidence Interval 63.1 to 74.3 | percentage of participants | |
| Percentage of Participants Alive (Overall Survival) | IMRT Plus Cetuximab | 76.5 | 95% Confidence Interval 71.4 to 81.6 | percentage of participants | |
| Percentage of Participants With ≥ Grade 3 Acute Dysphagia, Dry Mouth, or Skin Toxicity Related to Protocol Treatment | IMRT | Dysphagia | 13.1 | 95% Confidence Interval 9.7 to 17.6 | percentage of participants |
| Percentage of Participants With ≥ Grade 3 Acute Dysphagia, Dry Mouth, or Skin Toxicity Related to Protocol Treatment | IMRT Plus Cetuximab | Dysphagia | 21.7 | 95% Confidence Interval 17.3 to 27.0 | percentage of participants |
| Percentage of Participants With ≥ Grade 3 Acute Dysphagia, Dry Mouth, or Skin Toxicity Related to Protocol Treatment | IMRT | Dry mouth (xerostomia) | 3.5 | 95% Confidence Interval 1.9 to 6.4 | percentage of participants |
| Percentage of Participants With ≥ Grade 3 Acute Dysphagia, Dry Mouth, or Skin Toxicity Related to Protocol Treatment | IMRT Plus Cetuximab | Dry mouth (xerostomia) | 1.8 | 95% Confidence Interval 0.8 to 4.2 | percentage of participants |
| Percentage of Participants With ≥ Grade 3 Acute Dysphagia, Dry Mouth, or Skin Toxicity Related to Protocol Treatment | IMRT | Dermatitis radiation | 6.4 | 95% Confidence Interval 4.1 to 9.9 | percentage of participants |
| Percentage of Participants With ≥ Grade 3 Acute Dysphagia, Dry Mouth, or Skin Toxicity Related to Protocol Treatment | IMRT Plus Cetuximab | Dermatitis radiation | 17.0 | 95% Confidence Interval 13.1 to 21.9 | percentage of participants |
| Percentage of Participants With ≥ Grade 3 Acute Dysphagia, Dry Mouth, or Skin Toxicity Related to Protocol Treatment | IMRT | Rash acneiform | 0.0 | 95% Confidence Interval 0.0 to 1.3 | percentage of participants |
| Percentage of Participants With ≥ Grade 3 Acute Dysphagia, Dry Mouth, or Skin Toxicity Related to Protocol Treatment | IMRT Plus Cetuximab | Rash acneiform | 13.4 | 95% Confidence Interval 9.9 to 17.9 | percentage of participants |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IMRT | 314 | |
| Overall Study | STARTED | IMRT Plus Cetuximab | 313 | |
| Overall Study | Eligible | IMRT | 287 | |
| Overall Study | Eligible | IMRT Plus Cetuximab | 290 | |
| Overall Study | Eligible and Started Protocol Treatment | IMRT | 282 | |
| Overall Study | Eligible and Started Protocol Treatment | IMRT Plus Cetuximab | 276 | |
| Overall Study | COMPLETED | IMRT | 287 | |
| Overall Study | COMPLETED | IMRT Plus Cetuximab | 290 | |
| Overall Study | NOT COMPLETED | IMRT | 27 | |
| Overall Study | NOT COMPLETED | IMRT Plus Cetuximab | 23 |
Source ClinicalTrials.gov
Adverse events400
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 | Anemia | Blood and lymphatic system disorders | IMRT | 39 | 282 | |
| other | Anemia | Blood and lymphatic system disorders | IMRT Plus Cetuximab | 74 | 276 | |
| other | Ear pain | Ear and labyrinth disorders | IMRT | 17 | 282 | |
| other | Ear pain | Ear and labyrinth disorders | IMRT Plus Cetuximab | 23 | 276 | |
| other | Hearing impaired | Ear and labyrinth disorders | IMRT | 33 | 282 | |
| other | Hearing impaired | Ear and labyrinth disorders | IMRT Plus Cetuximab | 40 | 276 | |
| other | Hyperthyroidism | Endocrine disorders | IMRT | 3 | 282 | |
| other | Hyperthyroidism | Endocrine disorders | IMRT Plus Cetuximab | 16 | 276 | |
| other | Hypothyroidism | Endocrine disorders | IMRT | 43 | 282 | |
| other | Hypothyroidism | Endocrine disorders | IMRT Plus Cetuximab | 53 | 276 |
1 to 10 of 400Source ClinicalTrials.gov
See all 400 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IMRT | 97 | 287 |
| Total, all-cause mortality | IMRT Plus Cetuximab | 87 | 290 |
| Total, other adverse events | IMRT | 278 | 282 |
| Total, other adverse events | IMRT Plus Cetuximab | 275 | 276 |
| Total, serious adverse events | IMRT | 50 | 282 |
| Total, serious adverse events | IMRT Plus Cetuximab | 83 | 276 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39841939 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180868 | NRG Oncology Network Group Operations Center | WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S. | NRG ONCOLOGY FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| IMRT vs IMRT Plus Cetuximab: deaths from any cause | Trial comparisons |
| IMRT vs IMRT Plus Cetuximab: serious adverse events | 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.
GET https://conductscience.org/api/trials/v1/NCT00956007
GET https://conductscience.org/api/trials/v1/NCT00956007/results?page=2