Trial · NCT00112918
Combination Chemotherapy With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for High Risk Stage II or Stage III Colon Cancer
NCT00112918, Phase 3, Completed, Hoffmann-La Roche; results first posted 2012-09-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Combination Chemotherapy With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for High Risk Stage II or Stage III Colon Cancer. Trials, record NCT00112918. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00112918
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Chemotherapy With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for High Risk Stage II or Stage III Colon Cancer
- NCT number
- NCT00112918
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,451 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Colorectal Cancer
- Interventions
- Bevacizumab, Capecitabine, 5-Fluorouracil (5-FU), Leucovorin calcium, Oxaliplatin
- First posted
- 2005-06-03
- Last updated
- 2013-08-27
- Results first posted
- 2012-09-06
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease-free Survival in Stage III Cancer Patients - Time to Event | From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized). | Disease-free survival (DFS) was defined as the time from the date of randomization to the time of a recurrence, a new occurrence of colorectal cancer or death due to any cause, whichever occurred first. Patients without an event were censored at the last date the patient was known to be disease-free. Recurrence and new occurrence of colorectal cancer were based on tumor assessments made by the investigator. Patients with no tumor assessments after baseline but still alive at the time of the clinical cut-off were censored at day 1. |
| Primary | Disease-free Survival in Stage III Cancer Patients - Number of Events | From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized). | A disease-free survival (DFS) event was composed of a recurrence, a new occurrence of colorectal cancer or death due to any cause. Recurrence and new occurrence of colorectal cancer were based on tumor assessments made by the investigator. Triggering events for DFS are reported; a patient can have both recurrence and a new occurrence of colon cancer. |
| Secondary | Overall Survival in Stage III Cancer Patients - Time to Event | From first patient randomized until the clinical data cut-off date of 30 June 2010 (36 months after the last patient randomized). | Overall survival was defined as the time between date of randomization and date of death due to any cause. Patients not reported as having died at the time of the analysis were censored at the date they were last known to be alive. |
| Secondary | Overall Survival in Stage III Cancer Patients - Number of Events | From first patient randomized until the clinical data cut-off date of 30 June 2010 (36 months after the last patient randomized). | An overall survival event was death due to any cause. |
| Secondary | Overall Survival in Stage III Cancer Patients - Time to Event: Final Analysis | From first patient randomized until the final data cut-off date of 30 June 2012 (5 years after the last patient randomized). | Overall survival was defined as the time between date of randomization and date of death due to any cause. Patients not reported as having died at the time of the clinical cut-off date (30 June 2012) were censored at the date they were last known to be alive. |
| Secondary | Overall Survival in Stage III Cancer Patients - Number of Events: Final Analysis | From first patient randomized until the final data cut-off date of 30 June 2012 (5 years after the last patient randomized). | An overall survival event was death due to any cause. |
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 | Disease-free Survival in Stage III Cancer Patients - Time to Event | From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized). | The primary population for efficacy analyses was the intent to treat population (ITT; all randomized patients) with stage III disease. | months | MEDIAN |
| SECONDARY | Overall Survival in Stage III Cancer Patients - Time to Event | From first patient randomized until the clinical data cut-off date of 30 June 2010 (36 months after the last patient randomized). | ITT patients with Stage III disease. | months | MEDIAN |
| PRIMARY | Disease-free Survival in Stage III Cancer Patients - Number of Events | From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized). | The primary population for efficacy analyses was the intent to treat population (ITT; all randomized patients) with stage III disease. | participants | NUMBER |
| SECONDARY | Overall Survival in Stage III Cancer Patients - Number of Events | From first patient randomized until the clinical data cut-off date of 30 June 2010 (36 months after the last patient randomized). | ITT patients with Stage III disease. | participants | NUMBER |
| SECONDARY | Overall Survival in Stage III Cancer Patients - Time to Event: Final Analysis | From first patient randomized until the final data cut-off date of 30 June 2012 (5 years after the last patient randomized). | ITT patients with Stage III disease. | months | MEDIAN |
| SECONDARY | Overall Survival in Stage III Cancer Patients - Number of Events: Final Analysis | From first patient randomized until the final data cut-off date of 30 June 2012 (5 years after the last patient randomized). | ITT patients with Stage III disease. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease-free Survival in Stage III Cancer Patients - Time to Event | FOLFOX4 | NA | 95% Confidence Interval NA to NA | months | |
| Disease-free Survival in Stage III Cancer Patients - Time to Event | FOLFOX4 + Bv | NA | 95% Confidence Interval NA to NA | months | |
| Disease-free Survival in Stage III Cancer Patients - Time to Event | XELOX+Bv | NA | 95% Confidence Interval NA to NA | months | |
| Overall Survival in Stage III Cancer Patients - Time to Event | FOLFOX4 | NA | 95% Confidence Interval NA to NA | months | |
| Overall Survival in Stage III Cancer Patients - Time to Event | FOLFOX4 + Bv | NA | 95% Confidence Interval NA to NA | months | |
| Overall Survival in Stage III Cancer Patients - Time to Event | XELOX+Bv | NA | 95% Confidence Interval NA to NA | months | |
| Disease-free Survival in Stage III Cancer Patients - Number of Events | FOLFOX4 | Patients with a DFS event | 237 | participants | |
| Disease-free Survival in Stage III Cancer Patients - Number of Events | FOLFOX4 + Bv | Patients with a DFS event | 280 | participants | |
| Disease-free Survival in Stage III Cancer Patients - Number of Events | XELOX+Bv | Patients with a DFS event | 253 | participants | |
| Disease-free Survival in Stage III Cancer Patients - Number of Events | FOLFOX4 | Recurrence | 219 | participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | FOLFOX4 | 1,151 | |
| Overall Study | STARTED | FOLFOX4 + Bv | 1,155 | |
| Overall Study | STARTED | XELOX+Bv | 1,145 | |
| Overall Study | Received Treatment | FOLFOX4 | 1,126 | |
| Overall Study | Received Treatment | FOLFOX4 + Bv | 1,145 | |
| Overall Study | Received Treatment | XELOX+Bv | 1,135 | |
| Overall Study | Stage III Disease Population | FOLFOX4 | 955 | |
| Overall Study | Stage III Disease Population | FOLFOX4 + Bv | 960 | |
| Overall Study | Stage III Disease Population | XELOX+Bv | 952 | |
| Overall Study | COMPLETED | FOLFOX4 | 854 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events1,152
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 | Nausea | Gastrointestinal disorders | FOLFOX4 | 725 | 1,126 | |
| other | Nausea | Gastrointestinal disorders | FOLFOX4 + Bv | 761 | 1,145 | |
| other | Nausea | Gastrointestinal disorders | XELOX+Bv | 720 | 1,135 | |
| other | Diarrhoea | Gastrointestinal disorders | FOLFOX4 | 620 | 1,126 | |
| other | Diarrhoea | Gastrointestinal disorders | FOLFOX4 + Bv | 699 | 1,145 | |
| other | Diarrhoea | Gastrointestinal disorders | XELOX+Bv | 699 | 1,135 | |
| other | Vomiting | Gastrointestinal disorders | FOLFOX4 | 385 | 1,126 | |
| other | Vomiting | Gastrointestinal disorders | FOLFOX4 + Bv | 394 | 1,145 | |
| other | Vomiting | Gastrointestinal disorders | XELOX+Bv | 460 | 1,135 | |
| other | Stomatitis | Gastrointestinal disorders | FOLFOX4 | 310 | 1,126 |
1 to 10 of 1,152Source ClinicalTrials.gov
See all 1,152 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FOLFOX4 | ||
| Total, all-cause mortality | FOLFOX4 + Bv | ||
| Total, all-cause mortality | XELOX+Bv | ||
| Total, other adverse events | FOLFOX4 | 1,112 | 1,126 |
| Total, other adverse events | FOLFOX4 + Bv | 1,127 | 1,145 |
| Total, other adverse events | XELOX+Bv | 1,117 | 1,135 |
| Total, serious adverse events | FOLFOX4 | 226 | 1,126 |
| Total, serious adverse events | FOLFOX4 + Bv | 297 | 1,145 |
| Total, serious adverse events | XELOX+Bv | 284 | 1,135 |
Source ClinicalTrials.gov
Papers7
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 |
|---|---|---|---|---|---|
| P30CA016042 | Cancer Center Support Grant | TEITELL, MICHAEL A | UNIVERSITY OF CALIFORNIA LOS ANGELES | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
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/NCT00112918
GET https://conductscience.org/api/trials/v1/NCT00112918/results?page=2