Trial · NCT00381706
Combination Chemotherapy and Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer
NCT00381706, Phase 2, Completed, Alliance for Clinical Trials in Oncology; results first posted 2017-03-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Combination Chemotherapy and Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer. Trials, record NCT00381706. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00381706
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Chemotherapy and Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer
- NCT number
- NCT00381706
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 245 participants, actual
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Conditions
- Esophageal Cancer
- Interventions
- cetuximab, ECF, IC, FOLFOX
- First posted
- 2006-09-28
- Last updated
- 2021-09-29
- Results first posted
- 2017-03-15
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate (Complete and Partial) in Patients With Measurable Esophageal or GE Junction Adenocarcinoma | Up to 2 years post-treatment | Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria. Overall tumor response is the total number of CR and PRs in participants with adenocarcinoma who have received at least one cycle of therapy. |
| Secondary | Tumor Response Rate (Complete and Partial) in Patients With Squamous Cell Carcinoma | Up to 2 years post-treatment | Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria. Overall tumor response is the total number of CR and PRs in participants with squamous cell carcinoma who have received at least one cycle of therapy. |
| Secondary | Overall Survival in Patients With Adenocarcinoma | Up to 2 years post-treatment | Overall survival (OS) was defined as the time from study entry to death of any cause. The median OS with 95% CI was estimated using the Kaplan Meier method. |
| Secondary | Progression-free Survival in Patients With Adenocarcinoma | Up to 2 years post-treatment | Progression free survival (PFS) was defined as the time from study entry to progression or death of any cause. The median PFS with 95% CI was estimated using the Kaplan Meier method. |
| Secondary | Time to Treatment Failure in Patients With Adenocarcinoma | Up to 2 years post-treatment | Time to treatment failure (TTF) was measured from study entry until documented progression, death resulting from any cause, or end of protocol therapy because of unacceptable toxicity. The median TTF with 95% CI was estimated using the Kaplan Meier method. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Rate (Complete and Partial) in Patients With Measurable Esophageal or GE Junction Adenocarcinoma | Up to 2 years post-treatment | 13 participants did not meet the protocol defined requirements to be evaluated for response (measurable adencarcinoma receiving at least 1 cycle of chemotherapy). | percentage of participants | NUMBER |
| SECONDARY | Tumor Response Rate (Complete and Partial) in Patients With Squamous Cell Carcinoma | Up to 2 years post-treatment | 4 participants did not meet the protocol defined requirements to be evaluated for response (measurable squamous cell carcinoma receiving at least 1 cycle of chemotherapy). | percentage of participants | NUMBER |
| SECONDARY | Overall Survival in Patients With Adenocarcinoma | Up to 2 years post-treatment | months | MEDIAN | |
| SECONDARY | Progression-free Survival in Patients With Adenocarcinoma | Up to 2 years post-treatment | months | MEDIAN | |
| SECONDARY | Time to Treatment Failure in Patients With Adenocarcinoma | Up to 2 years post-treatment | months | MEDIAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate (Complete and Partial) in Patients With Measurable Esophageal or GE Junction Adenocarcinoma | Arm A: Adenocarcinoma (ECF + Cetuximab) | 61 | 95% Confidence Interval 48 to 72 | percentage of participants | |
| Response Rate (Complete and Partial) in Patients With Measurable Esophageal or GE Junction Adenocarcinoma | Arm B: Adenocarcinoma (IC + Cetuximab) | 45 | 95% Confidence Interval 33 to 57 | percentage of participants | |
| Response Rate (Complete and Partial) in Patients With Measurable Esophageal or GE Junction Adenocarcinoma | Arm C: Adenocarcinoma (FOLFOX + Cetuximab) | 54 | 95% Confidence Interval 42 to 66 | percentage of participants | |
| Tumor Response Rate (Complete and Partial) in Patients With Squamous Cell Carcinoma | Arm A: Squamous Cell Carcinoma (ECF + Cetuximab) | 67 | percentage of participants | ||
| Tumor Response Rate (Complete and Partial) in Patients With Squamous Cell Carcinoma | Arm B: Squamous Cell Carcinoma (IC + Cetuximab) | 13 | percentage of participants | ||
| Tumor Response Rate (Complete and Partial) in Patients With Squamous Cell Carcinoma | Arm C: Squamous Cell Carcinoma (FOLFOX + Cetuximab) | 60 | percentage of participants | ||
| Overall Survival in Patients With Adenocarcinoma | Arm A: Adenocarcinoma (ECF + Cetuximab) | 11.6 | 95% Confidence Interval 8.1 to 13.4 | months | |
| Overall Survival in Patients With Adenocarcinoma | Arm B: Adenocarcinoma (IC + Cetuximab) | 8.6 | 95% Confidence Interval 6.0 to 12.4 | months | |
| Overall Survival in Patients With Adenocarcinoma | Arm C: Adenocarcinoma (FOLFOX + Cetuximab) | 11.8 | 95% Confidence Interval 8.8 to 13.9 | months | |
| Progression-free Survival in Patients With Adenocarcinoma | Arm A: Adenocarcinoma (ECF + Cetuximab) | 7.1 | 95% Confidence Interval 4.5 to 8.4 | months |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (ECF + Cetuximab) | 82 | |
| Overall Study | STARTED | Arm B (IC + Cetuximab) | 83 | |
| Overall Study | STARTED | ARM C (FOLFOX + Cetuximab) | 80 | |
| Overall Study | COMPLETED | Arm A (ECF + Cetuximab) | 75 | |
| Overall Study | COMPLETED | Arm B (IC + Cetuximab) | 81 | |
| Overall Study | COMPLETED | ARM C (FOLFOX + Cetuximab) | 79 | |
| Overall Study | NOT COMPLETED | Arm A (ECF + Cetuximab) | 7 | |
| Overall Study | NOT COMPLETED | Arm B (IC + Cetuximab) | 2 | |
| Overall Study | NOT COMPLETED | ARM C (FOLFOX + Cetuximab) | 1 |
Source ClinicalTrials.gov
Adverse events2,340
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 disorder | Blood and lymphatic system disorders | Arm A: Adenocarcinoma (ECF + Cetuximab) | 2 | 67 | 36 |
| other | Blood disorder | Blood and lymphatic system disorders | Arm B: Adenocarcinoma (IC + Cetuximab) | 1 | 73 | 3 |
| other | Blood disorder | Blood and lymphatic system disorders | Arm C: Adenocarcinoma (FOLFOX + Cetuximab) | 2 | 73 | 21 |
| other | Blood disorder | Blood and lymphatic system disorders | Arm A: Squamous Cell Carcinoma (ECF + Cetuximab) | 0 | 8 | 0 |
| other | Blood disorder | Blood and lymphatic system disorders | Arm B: Squamous Cell Carcinoma (IC + Cetuximab) | 0 | 8 | 0 |
| other | Blood disorder | Blood and lymphatic system disorders | Arm C: Squamous Cell Carcinoma (FOLFOX + Cetuximab) | 0 | 6 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm A: Adenocarcinoma (ECF + Cetuximab) | 3 | 67 | 3 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm B: Adenocarcinoma (IC + Cetuximab) | 1 | 73 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm C: Adenocarcinoma (FOLFOX + Cetuximab) | 2 | 73 | 2 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm A: Squamous Cell Carcinoma (ECF + Cetuximab) | 1 | 8 | 1 |
1 to 10 of 2,340Source ClinicalTrials.gov
See all 2,340 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: Adenocarcinoma (ECF + Cetuximab) | ||
| Total, all-cause mortality | Arm B: Adenocarcinoma (IC + Cetuximab) | ||
| Total, all-cause mortality | Arm C: Adenocarcinoma (FOLFOX + Cetuximab) | ||
| Total, all-cause mortality | Arm A: Squamous Cell Carcinoma (ECF + Cetuximab) | ||
| Total, all-cause mortality | Arm B: Squamous Cell Carcinoma (IC + Cetuximab) | ||
| Total, all-cause mortality | Arm C: Squamous Cell Carcinoma (FOLFOX + Cetuximab) | ||
| Total, other adverse events | Arm A: Adenocarcinoma (ECF + Cetuximab) | 65 | 67 |
| Total, other adverse events | Arm B: Adenocarcinoma (IC + Cetuximab) | 68 | 73 |
| Total, other adverse events | Arm C: Adenocarcinoma (FOLFOX + Cetuximab) | 71 | 73 |
| Total, other adverse events | Arm A: Squamous Cell Carcinoma (ECF + Cetuximab) | 8 | 8 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27382098 | DERIVED |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00381706
GET https://conductscience.org/api/trials/v1/NCT00381706/events?page=2