Trial · NCT00265850
Cetuximab and/or Bevacizumab Combined With Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
NCT00265850, Phase 3, Completed, Alliance for Clinical Trials in Oncology; results first posted 2017-04-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cetuximab and/or Bevacizumab Combined With Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer. Trials, record NCT00265850. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00265850
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cetuximab and/or Bevacizumab Combined With Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
- NCT number
- NCT00265850
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,334 participants, actual
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Conditions
- Colorectal Cancer
- Interventions
- bevacizumab, cetuximab, FOLFOX or, FOLFIRI
- First posted
- 2005-12-15
- Last updated
- 2026-08-07
- Results first posted
- 2017-04-26
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | Up to 5 years post-treatment | Survival time will be defined as the time from registration to death. Time to event distributions will be estimated using the Kaplan-Meier method. Overall Survival (OS) will be compared between Arm A and Arm B. |
| Secondary | Progression-free Survival (PFS) | Up to 5 years post-treatment | PFS will be measured from study entry until first documented progression or death from any cause. Time to event distributions will be estimated using the Kaplan-Meier method. PFS will be compared between Arm A and Arm B. |
| Secondary | Time to Treatment Failure | Up to 5 years post-treatment | |
| Secondary | Duration of Tumor Response | Up to 5 years post-treatment |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | Up to 5 years post-treatment | All eligible KRAS wild type patients that began treatment were included in this endpoint. | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | Up to 5 years post-treatment | All eligible KRAS wild type patients were included in this analysis. | months | MEDIAN |
| SECONDARY | Time to Treatment Failure | Up to 5 years post-treatment | |||
| SECONDARY | Duration of Tumor Response | Up to 5 years post-treatment |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Arm A: FOLFOX or FOLFIRI + Bevacizumab | 29.0 | 95% Confidence Interval 25.6 to 31.2 | months | |
| Overall Survival | Arm B: FOLFOX or FOLFIRI + Cetuximab | 30.0 | 95% Confidence Interval 27.5 to 32.8 | months | |
| Progression-free Survival (PFS) | Arm A: FOLFOX or FOLFIRI + Bevacizumab | 10.6 | 95% Confidence Interval 9.5 to 11.1 | months | |
| Progression-free Survival (PFS) | Arm B: FOLFOX or FOLFIRI + Cetuximab | 10.5 | 95% Confidence Interval 9.5 to 11.3 | months |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A: FOLFOX or FOLFIRI + Bevacizumab | 899 | |
| Overall Study | STARTED | Arm B: FOLFOX or FOLFIRI + Cetuximab | 902 | |
| Overall Study | STARTED | Arm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab | 533 | |
| Overall Study | COMPLETED | Arm A: FOLFOX or FOLFIRI + Bevacizumab | 899 | |
| Overall Study | COMPLETED | Arm B: FOLFOX or FOLFIRI + Cetuximab | 902 | |
| Overall Study | COMPLETED | Arm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab | 533 | |
| Overall Study | NOT COMPLETED | Arm A: FOLFOX or FOLFIRI + Bevacizumab | 0 | |
| Overall Study | NOT COMPLETED | Arm B: FOLFOX or FOLFIRI + Cetuximab | 0 | |
| Overall Study | NOT COMPLETED | Arm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab | 0 |
Source ClinicalTrials.gov
Adverse events908
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: FOLFOX or FOLFIRI + Bevacizumab | 0 | 559 | 0 |
| other | Blood disorder | Blood and lymphatic system disorders | Arm B: FOLFOX or FOLFIRI + Cetuximab | 4 | 578 | 4 |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Arm A: FOLFOX or FOLFIRI + Bevacizumab | 0 | 559 | 0 |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Arm B: FOLFOX or FOLFIRI + Cetuximab | 1 | 578 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm A: FOLFOX or FOLFIRI + Bevacizumab | 5 | 559 | 5 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm B: FOLFOX or FOLFIRI + Cetuximab | 10 | 578 | 10 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Arm A: FOLFOX or FOLFIRI + Bevacizumab | 95 | 559 | 161 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Arm B: FOLFOX or FOLFIRI + Cetuximab | 83 | 578 | 145 |
| other | Hemolysis | Blood and lymphatic system disorders | Arm A: FOLFOX or FOLFIRI + Bevacizumab | 7 | 559 | 7 |
| other | Hemolysis | Blood and lymphatic system disorders | Arm B: FOLFOX or FOLFIRI + Cetuximab | 5 | 578 | 6 |
1 to 10 of 908Source ClinicalTrials.gov
See all 908 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: FOLFOX or FOLFIRI + Bevacizumab | ||
| Total, all-cause mortality | Arm B: FOLFOX or FOLFIRI + Cetuximab | ||
| Total, other adverse events | Arm A: FOLFOX or FOLFIRI + Bevacizumab | 531 | 559 |
| Total, other adverse events | Arm B: FOLFOX or FOLFIRI + Cetuximab | 548 | 578 |
| Total, serious adverse events | Arm A: FOLFOX or FOLFIRI + Bevacizumab | 98 | 559 |
| Total, serious adverse events | Arm B: FOLFOX or FOLFIRI + Cetuximab | 111 | 578 |
Source ClinicalTrials.gov
Papers8
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|---|---|---|---|
| U10CA037447 | Cancer and Leukemia Group B CCOP Research Base | BERTAGNOLLI, MONICA M; PASKETT, ELECTRA D. | BRIGHAM AND WOMEN'S HOSPITAL | NATIONAL CANCER INSTITUTE | 1985 to 2015 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm A: FOLFOX or FOLFIRI + Bevacizumab vs Arm B: FOLFOX or FOLFIRI + 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.
GET https://conductscience.org/api/trials/v1/NCT00265850
GET https://conductscience.org/api/trials/v1/NCT00265850/events?page=2