Trial · NCT00655876
Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer
NCT00655876, Phase 3, Completed, Radiation Therapy Oncology Group; results first posted 2018-03-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer. Trials, record NCT00655876. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00655876
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer
- NCT number
- NCT00655876
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 344 participants, actual
- Lead sponsor
- Radiation Therapy Oncology Group
- Conditions
- Esophageal Cancer
- Interventions
- cetuximab, cisplatin, paclitaxel, radiation therapy
- First posted
- 2008-04-10
- Last updated
- 2022-06-14
- Results first posted
- 2018-03-14
- Limitations and caveats
After a United Kingdom trial failed to show a benefit for cetuximab, accrual was suspended and the 3rd planned interim analysis done. After discussions with the Data Monitoring Committee, the study permanently closed to accrual on 2/8/2013.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (24-month Rate Reported) | From randomization to last follow-up. Analysis was planned to occur after at least 281 deaths had been observed. Maximum follow-up at time of analysis was 74.5 months. | Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur after at least 281 deaths have been observed, unless an early stopping rule was satisfied. |
| Secondary | Local Failure (24-month Rate Reported) | From randomization to last follow-up. Analysis was planned to occur after at least 281 deaths had been observed. Maximum follow-up at time of analysis was 74.5 months. | Local failure (LF) was defined as residual cancer on posttreatment biopsy findings or biopsy-proven recurrent primary disease and local failure time was measured from randomization to failure or last follow-up. Nonprotocol surgery to the primary site with gross residual disease was considered a LF as of the surgery date. Patients with no viable disease or microscopic residual disease at nonprotocol surgery were censored for LF as of the surgery date. Local failure was estimated by the cumulative incidence method with death considered a competing risk. |
| Secondary | Percentage of Patients With Acute Grade 4 or 5 Non-hematologic Treatment-related Adverse Events | From start of treatment to 90 days from end of treatment | Adverse events (AE) are graded using CTCAE v3.0. 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 | Endoscopic Complete Response Rate | From randomization to 6-8 weeks after completion of chemoradiation (11-14 weeks) | All patients were to undergo a repeat endoscopy (EUS) 6-8 weeks after the completion of chemoradiation. At the time of EUS a visual inspection of the site of the original primary disease would be documented. Those patients found to be free of disease were NOT required to undergo repeat biopsy. These patients would be scored as clinical complete responses (cCR). Patients deemed to have residual disease or suspicion of residual disease would undergo a biopsy in order to pathologically confirm findings. Any patient with pathologically confirmed residual disease would be scored as a local failure. Patients who were pathologically proven to have no evidence of disease would be scored as cCRs. |
| Secondary | Percentage of Patients With Improvement in the Functional Assessment of Cancer Therapy - Esophagus (FACT-E) Esophageal Cancer Subscale (ECS) Subscale After Treatment | Baseline, 6-8 weeks after completion of chemoradiation , 1 year and 2 years from treatment start. | The ECS is a 17-item self-report instrument designed to measure multidimensional quality of life in patients with esophagus cancer. It is to be administered with the Functional Assessment of Cancer Therapy - General (FACT-G). 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 0-68. 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-E 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. Improvement in FACT-E score is defined as an increase from baseline score of at least 5 points. |
| Secondary | Quality-adjusted Survival (Using EQ-5D), Only if Primary Hypothesis is Supported | Baseline, 6-8 weeks after completion of chemoradiation, 1 year and 2 years from treatment start. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (24-month Rate Reported) | From randomization to last follow-up. Analysis was planned to occur after at least 281 deaths had been observed. Maximum follow-up at time of analysis was 74.5 months. | Eligible patients \[We have defined completed as patients who have data available for analysis\] | percentage of participants | NUMBER |
| SECONDARY | Local Failure (24-month Rate Reported) | From randomization to last follow-up. Analysis was planned to occur after at least 281 deaths had been observed. Maximum follow-up at time of analysis was 74.5 months. | All eligible patients | percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients With Acute Grade 4 or 5 Non-hematologic Treatment-related Adverse Events | From start of treatment to 90 days from end of treatment | Eligible patients who started study treatment | percentage of participants | NUMBER |
| SECONDARY | Endoscopic Complete Response Rate | From randomization to 6-8 weeks after completion of chemoradiation (11-14 weeks) | Eligible patients who started study treatment and had an endoscopy performed | percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients With Improvement in the Functional Assessment of Cancer Therapy - Esophagus (FACT-E) Esophageal Cancer Subscale (ECS) Subscale After Treatment | Baseline, 6-8 weeks after completion of chemoradiation , 1 year and 2 years from treatment start. | Patients who consented to collection of patient reported outcomes and quality of life (PRO-QOL) data and had FACT-E scores at baseline and corresponding timepoint | percentage of participants | NUMBER |
| SECONDARY | Quality-adjusted Survival (Using EQ-5D), Only if Primary Hypothesis is Supported | Baseline, 6-8 weeks after completion of chemoradiation, 1 year and 2 years from treatment start. | The protocol states that this study endpoint will be addressed ONLY if primary outcome results are positive, i.e. support the primary hypothesis of this study. The primary hypothesis was not supported therefore no patients were analyzed for this outcome measure. |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (24-month Rate Reported) | Chemoradiation + Cetuximab | 44.9 | 95% Confidence Interval 36.9 to 52.5 | percentage of participants | |
| Overall Survival (24-month Rate Reported) | Chemoradiation | 44.0 | 95% Confidence Interval 36.4 to 51.4 | percentage of participants | |
| Local Failure (24-month Rate Reported) | Chemoradiation + Cetuximab | 47 | 95% Confidence Interval 38.3 to 56.6 | percentage of participants | |
| Local Failure (24-month Rate Reported) | Chemoradiation | 48.8 | 95% Confidence Interval 40.8 to 57.5 | percentage of participants | |
| Percentage of Patients With Acute Grade 4 or 5 Non-hematologic Treatment-related Adverse Events | Chemoradiation + Cetuximab | 15.7 | 95% Confidence Interval 10.8 to 22.3 | percentage of participants | |
| Percentage of Patients With Acute Grade 4 or 5 Non-hematologic Treatment-related Adverse Events | Chemoradiation | 7.8 | 95% Confidence Interval 4.6 to 12.9 | percentage of participants | |
| Endoscopic Complete Response Rate | Chemoradiation + Cetuximab | 56.3 | percentage of participants | ||
| Endoscopic Complete Response Rate | Chemoradiation | 57.9 | percentage of participants | ||
| Percentage of Patients With Improvement in the Functional Assessment of Cancer Therapy - Esophagus (FACT-E) Esophageal Cancer Subscale (ECS) Subscale After Treatment | Chemoradiation + Cetuximab | 6-8 weeks post-treatment | 36.8 | percentage of participants | |
| Percentage of Patients With Improvement in the Functional Assessment of Cancer Therapy - Esophagus (FACT-E) Esophageal Cancer Subscale (ECS) Subscale After Treatment | Chemoradiation | 6-8 weeks post-treatment | 52.8 | percentage of participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chemoradiation + Cetuximab | 168 | |
| Overall Study | STARTED | Chemoradiation | 176 | |
| Overall Study | COMPLETED | Chemoradiation + Cetuximab | 159 | |
| Overall Study | COMPLETED | Chemoradiation | 169 | |
| Overall Study | NOT COMPLETED | Chemoradiation + Cetuximab | 9 | |
| Overall Study | NOT COMPLETED | Chemoradiation | 7 |
Source ClinicalTrials.gov
Adverse events428
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 | Hemoglobin decreased | Blood and lymphatic system disorders | Chemoradiation + Cetuximab | 88 | 162 | |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Chemoradiation | 87 | 173 | |
| other | Pericardial effusion | Cardiac disorders | Chemoradiation + Cetuximab | 8 | 162 | |
| other | Pericardial effusion | Cardiac disorders | Chemoradiation | 2 | 173 | |
| other | Abdominal pain | Gastrointestinal disorders | Chemoradiation + Cetuximab | 21 | 162 | |
| other | Abdominal pain | Gastrointestinal disorders | Chemoradiation | 20 | 173 | |
| other | Constipation | Gastrointestinal disorders | Chemoradiation + Cetuximab | 57 | 162 | |
| other | Constipation | Gastrointestinal disorders | Chemoradiation | 47 | 173 | |
| other | Diarrhea | Gastrointestinal disorders | Chemoradiation + Cetuximab | 54 | 162 | |
| other | Diarrhea | Gastrointestinal disorders | Chemoradiation | 35 | 173 |
1 to 10 of 428Source ClinicalTrials.gov
See all 428 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chemoradiation + Cetuximab | ||
| Total, all-cause mortality | Chemoradiation | ||
| Total, other adverse events | Chemoradiation + Cetuximab | 156 | 162 |
| Total, other adverse events | Chemoradiation | 169 | 173 |
| Total, serious adverse events | Chemoradiation + Cetuximab | 88 | 162 |
| Total, serious adverse events | Chemoradiation | 88 | 173 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28687830 | RESULT |
Source 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 |
|---|
| Chemoradiation + Cetuximab vs Chemoradiation: 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.
GET https://conductscience.org/api/trials/v1/NCT00655876
GET https://conductscience.org/api/trials/v1/NCT00655876/events?page=2