Trial · NCT01302834
Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal Cancer
NCT01302834, Phase 3, Completed, Radiation Therapy Oncology Group; results first posted 2020-01-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal Cancer. Trials, record NCT01302834. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01302834
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal Cancer
- NCT number
- NCT01302834
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 987 participants, actual
- Lead sponsor
- Radiation Therapy Oncology Group
- Conditions
- Head and Neck Cancer, Precancerous Condition
- Interventions
- cetuximab, cisplatin, IMRT
- First posted
- 2011-02-24
- Last updated
- 2026-07-20
- Results first posted
- 2020-01-09
- Limitations and caveats
- At the third interim analysis the NRG Oncology Data Monitoring Committee recommended the public release of study results.
Source ClinicalTrials.gov
Registered outcomes48
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | 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. | 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. |
| Secondary | Progression-free Survival | 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. | 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. |
| Secondary | Time to Local-regional Failure | 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. | 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. |
| Secondary | Time to Distant Metastasis | 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. | 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. |
| Secondary | Time to Secondary Primary Cancer | 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. | 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. |
| Secondary | Distribution of First Progression Events | 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. | 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." |
| Secondary | Percentage of Participants Experiencing Early Death | 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. | Early death is defined as death due to adverse event or within 30 days of treatment completion. |
| Secondary | Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: During Treatment | From start of treatment to end of treatment, approximately 6 weeks | 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 |
| Secondary | Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: 1 Month After End of Study Treatment | From start of treatment to approximately 2.5 months (1 month after the end of 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 |
| Secondary | Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: 3 Months After the End of Study Treatment | From start of treatment to approximately 4.5 months (3 months after the end of 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 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 registered outcomesOutcomes43
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | 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. | Eligible participants | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival | 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. | Eligible participants | percentage of participants | NUMBER |
| SECONDARY | Time to Local-regional Failure | 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. | Eligible participants | percentage of participants | NUMBER |
| SECONDARY | Time to Distant Metastasis | 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. | Eligible participants | percentage of participants | NUMBER |
| SECONDARY | Time to Secondary Primary Cancer | 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. | Eligible participants | percentage of participants | NUMBER |
| SECONDARY | Distribution of First Progression Events | 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. | Eligible participants with progression-free survival failure | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Experiencing Early Death | 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. | Eligible patients who started study treatment | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: During Treatment | From start of treatment to end of treatment, approximately 6 weeks | All eligible patients who started study treatment | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: 1 Month After End of Study Treatment | From start of treatment to approximately 2.5 months (1 month after the end of treatment) | Eligible patients who started study treatment and had adverse events assessment at 1 month after treatment end | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: 3 Months After the End of Study Treatment | From start of treatment to approximately 4.5 months (3 months after the end of treatment) | Eligible patients who started study treatment and had adverse events assessment at 3 months after treatment end | percentage of participants | NUMBER |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 outcomesResults by group139
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | IMRT + Cisplatin | 84.6 | 95% Confidence Interval 80.6 to 88.6 | percentage of participants | |
| Overall Survival | IMRT + Cetuximab | 77.9 | 95% Confidence Interval 73.4 to 82.5 | percentage of participants | |
| Progression-free Survival | IMRT + Cisplatin | 78.4 | 95% Confidence Interval 73.8 to 83.0 | percentage of participants | |
| Progression-free Survival | IMRT + Cetuximab | 67.3 | 95% Confidence Interval 62.4 to 72.2 | percentage of participants | |
| Time to Local-regional Failure | IMRT + Cisplatin | 9.9 | 95% Confidence Interval 6.9 to 13.6 | percentage of participants | |
| Time to Local-regional Failure | IMRT + Cetuximab | 17.3 | 95% Confidence Interval 13.7 to 21.4 | percentage of participants | |
| Time to Distant Metastasis | IMRT + Cisplatin | 8.6 | 95% Confidence Interval 5.8 to 11.9 | percentage of participants | |
| Time to Distant Metastasis | IMRT + Cetuximab | 11.7 | 95% Confidence Interval 8.6 to 15.3 | percentage of participants | |
| Time to Secondary Primary Cancer | IMRT + Cisplatin | 9.9 | 95% Confidence Interval 6.9 to 13.4 | percentage of participants | |
| Time to Secondary Primary Cancer | IMRT + Cetuximab | 10.3 | 95% Confidence Interval 7.1 to 14.2 | percentage of participants |
1 to 10 of 139Source ClinicalTrials.gov
See all 139 results by groupParticipant flow32
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IMRT + Cisplatin | 424 | |
| Overall Study | STARTED | IMRT + Cetuximab | 425 | |
| Overall Study | Eligible | IMRT + Cisplatin | 406 | |
| Overall Study | Eligible | IMRT + Cetuximab | 399 | |
| Overall Study | Started Treatment | IMRT + Cisplatin | 398 | |
| Overall Study | Started Treatment | IMRT + Cetuximab | 394 | |
| Overall Study | AE Assessed 1 Month Post-treatment (PT) | IMRT + Cisplatin | 369 | |
| Overall Study | AE Assessed 1 Month Post-treatment (PT) | IMRT + Cetuximab | 363 | |
| Overall Study | AE Assessed 3 Months PT | IMRT + Cisplatin | 359 | |
| Overall Study | AE Assessed 3 Months PT | IMRT + Cetuximab | 367 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 participant flowAdverse events476
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 + Cisplatin | 185 | 398 | |
| other | Anemia | Blood and lymphatic system disorders | IMRT + Cetuximab | 118 | 394 | |
| other | Ear pain | Ear and labyrinth disorders | IMRT + Cisplatin | 30 | 398 | |
| other | Ear pain | Ear and labyrinth disorders | IMRT + Cetuximab | 36 | 394 | |
| other | Hearing impaired | Ear and labyrinth disorders | IMRT + Cisplatin | 192 | 398 | |
| other | Hearing impaired | Ear and labyrinth disorders | IMRT + Cetuximab | 104 | 394 | |
| other | Tinnitus | Ear and labyrinth disorders | IMRT + Cisplatin | 204 | 398 | |
| other | Tinnitus | Ear and labyrinth disorders | IMRT + Cetuximab | 100 | 394 | |
| other | Hyperthyroidism | Endocrine disorders | IMRT + Cisplatin | 20 | 398 | |
| other | Hyperthyroidism | Endocrine disorders | IMRT + Cetuximab | 10 | 394 |
1 to 10 of 476Source ClinicalTrials.gov
See all 476 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IMRT + Cisplatin | 64 | 406 |
| Total, all-cause mortality | IMRT + Cetuximab | 86 | 399 |
| Total, other adverse events | IMRT + Cisplatin | 398 | 398 |
| Total, other adverse events | IMRT + Cetuximab | 393 | 394 |
| Total, serious adverse events | IMRT + Cisplatin | 177 | 398 |
| Total, serious adverse events | IMRT + Cetuximab | 115 | 394 |
Source ClinicalTrials.gov
Papers5
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| IMRT + Cisplatin vs IMRT + Cetuximab: deaths from any cause | Trial comparisons |
| IMRT + Cisplatin vs IMRT + 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/NCT01302834
GET https://conductscience.org/api/trials/v1/NCT01302834/registered?page=2