Trial · NCT00096278
Fluorouracil, Leucovorin, and Oxaliplatin With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II or Stage III Colon Cancer
NCT00096278, Phase 3, Completed, National Cancer Institute (NCI); results first posted 2012-12-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Fluorouracil, Leucovorin, and Oxaliplatin With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II or Stage III Colon Cancer. Trials, record NCT00096278. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00096278
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fluorouracil, Leucovorin, and Oxaliplatin With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II or Stage III Colon Cancer
- NCT number
- NCT00096278
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,710 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Colon Adenocarcinoma, Stage IIA Colon Cancer AJCC v7, Stage IIB Colon Cancer AJCC v7, Stage IIC Colon Cancer AJCC v7, Stage IIIA Colon Cancer AJCC v7, Stage IIIB Colon Cancer AJCC v7, Stage IIIC Colon Cancer AJCC v7
- Interventions
- Bevacizumab, Fluorouracil, Leucovorin Calcium, Oxaliplatin
- First posted
- 2004-11-09
- Last updated
- 2019-07-30
- Results first posted
- 2012-12-03
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease-free Survival | 3 years | Where events are defined as recurrence, second primary cancer, or death from any cause |
| Secondary | Survival | 5 years | Percentage of patients who did not experience an event where events are defined as death from any cause. |
| Other | Bevacizumab Immunogenicity and Post-treatment Serum Levels of Bevacizumab in Patients Receiving Bevacizumab | Group 2: Pre-therapy, every 2 weeks during chemotherapy/bevacizumab therapy, every 6 weeks during bevacizumab therapy and at 3 and 6 months after completion of bevacizumab therapy | |
| Other | Ovarian Function in Premenopausal Women as Measured by Serum Ovarian Function Test | Group 2: Measured pre-therapy and then every 6 months for 2 years following randomization | |
| Other | Delayed Vascular Events Such as Myocardial Infarction, Central Nervous System (CNS) Ischemia, and Thrombosis in Patients Receiving Chemotherapy + Bevacizumab | Events measured regularly during chemotherapy and bevacizumab therapy | |
| Other | As Measured by Blood Pressure and Antihypertensive Medication Hypertension | Group 2, every 3 months for one year post treatment | |
| Other | The Risk Factors for Development of Proteinuria | For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months | |
| Other | Proteinuria With Clinical Sequelae | For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months | |
| Other | Proteinuria After Completion of Bevacizumab | For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease-free Survival | 3 years | percentage of patients | NUMBER | |
| SECONDARY | Survival | 5 years | Survival analysis was done 2 years after Disease Free Survival analysis. For Arm 2 one additional patient had follow up at the later analysis. | percentage of patients | NUMBER |
| OTHER_PRE_SPECIFIED | Bevacizumab Immunogenicity and Post-treatment Serum Levels of Bevacizumab in Patients Receiving Bevacizumab | Group 2: Pre-therapy, every 2 weeks during chemotherapy/bevacizumab therapy, every 6 weeks during bevacizumab therapy and at 3 and 6 months after completion of bevacizumab therapy | Results of definitive analysis were negative. Tertiary outcomes therefore were not analyzed. | ||
| OTHER_PRE_SPECIFIED | Ovarian Function in Premenopausal Women as Measured by Serum Ovarian Function Test | Group 2: Measured pre-therapy and then every 6 months for 2 years following randomization | Results of definitive analysis were negative. Tertiary outcomes therefore were not analyzed. | ||
| OTHER_PRE_SPECIFIED | Delayed Vascular Events Such as Myocardial Infarction, Central Nervous System (CNS) Ischemia, and Thrombosis in Patients Receiving Chemotherapy + Bevacizumab | Events measured regularly during chemotherapy and bevacizumab therapy | Results of definitive analysis were negative. Tertiary outcomes therefore were not analyzed. | ||
| OTHER_PRE_SPECIFIED | As Measured by Blood Pressure and Antihypertensive Medication Hypertension | Group 2, every 3 months for one year post treatment | Results of definitive analysis were negative. Tertiary outcomes therefore were not analyzed. | ||
| OTHER_PRE_SPECIFIED | The Risk Factors for Development of Proteinuria | For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months | |||
| OTHER_PRE_SPECIFIED | Proteinuria With Clinical Sequelae | For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months | |||
| OTHER_PRE_SPECIFIED | Proteinuria After Completion of Bevacizumab | For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months |
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 |
|---|---|---|---|---|---|
| Disease-free Survival | Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil | 75.5 | percentage of patients | ||
| Disease-free Survival | Arm 2: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab | 77.4 | percentage of patients | ||
| Survival | Arm I (mFOLFOX6) | 77.6 | percentage of patients | ||
| Survival | Arm II (Bevacizumab, mFOLFOX6) | 78.7 | percentage of patients |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil | 1,356 | |
| Overall Study | STARTED | Arm 2: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab | 1,354 | |
| Overall Study | COMPLETED | Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil | 1,338 | |
| Overall Study | COMPLETED | Arm 2: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab | 1,334 | |
| Overall Study | NOT COMPLETED | Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil | 18 | |
| Overall Study | NOT COMPLETED | Arm 2: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab | 20 |
Source ClinicalTrials.gov
Adverse events376
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 | Dehydration | Metabolism and nutrition disorders | Oxaliplatin + Leucovorin + 5-Fluorouracil | 53 | 1,326 | |
| other | Dehydration | Metabolism and nutrition disorders | Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab | 67 | 1,334 | |
| other | Depression | Psychiatric disorders | Oxaliplatin + Leucovorin + 5-Fluorouracil | 53 | 1,326 | |
| other | Depression | Psychiatric disorders | Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab | 70 | 1,334 | |
| other | Diarrhea | Gastrointestinal disorders | Oxaliplatin + Leucovorin + 5-Fluorouracil | 128 | 1,326 | |
| other | Diarrhea | Gastrointestinal disorders | Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab | 153 | 1,334 | |
| other | Fatigue | General disorders | Oxaliplatin + Leucovorin + 5-Fluorouracil | 98 | 1,326 | |
| other | Fatigue | General disorders | Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab | 122 | 1,334 | |
| other | Hypertension | Vascular disorders | Oxaliplatin + Leucovorin + 5-Fluorouracil | 24 | 1,326 | |
| other | Hypertension | Vascular disorders | Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab | 172 | 1,334 |
1 to 10 of 376Source ClinicalTrials.gov
See all 376 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oxaliplatin + Leucovorin + 5-Fluorouracil | ||
| Total, all-cause mortality | Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab | ||
| Total, other adverse events | Oxaliplatin + Leucovorin + 5-Fluorouracil | 954 | 1,326 |
| Total, other adverse events | Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab | 1,043 | 1,334 |
| Total, serious adverse events | Oxaliplatin + Leucovorin + 5-Fluorouracil | 81 | 1,326 |
| Total, serious adverse events | Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab | 270 | 1,334 |
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 |
|---|---|---|---|---|---|
| U10CA012027 | NATIONAL SURGICAL ADJUVANT BREAST AND BOWEL PROJECT | WOLMARK, NORMAN | NSABP FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 1985 to 2012 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Oxaliplatin + Leucovorin + 5-Fluorouracil vs Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab: 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/NCT00096278
GET https://conductscience.org/api/trials/v1/NCT00096278/events?page=2