Trial · NCT00217737

Oxaliplatin, Leucovorin, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer

NCT00217737, Phase 3, Completed, National Cancer Institute (NCI); results first posted 2025-07-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Oxaliplatin, Leucovorin, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer. Trials, record NCT00217737. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00217737

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Oxaliplatin, Leucovorin, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer
NCT number: NCT00217737
Status: Completed
Phases: Phase 3
Enrollment: 2,431 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
Interventions: Bevacizumab, Fluorouracil, Leucovorin, Oxaliplatin
First posted: 2005-09-22
Last updated: 2026-08-25
Results first posted: 2025-07-20

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Disease-free Survival Rate at 5 Years	Assessed every 3 months for patients within 2 years of step 2 randomization, every 6 months during 3-5 years from step 2 randomization, and then every 12 months until 10 years from step 2 randomization	Disease-free survival (DFS) is defined as the time from randomization to the earlier of disease recurrence, new invasive primary cancer, or death from any cause. The Kaplan-Meier estimates were used to characterize the 5-year DFS rates.
Secondary	Overall Survival Rate at 5 Years	Assessed every 3 months for patients within 2 years of step 2 randomization, every 6 months during 3-5 years from step 2 randomization, and then every 12 months until 10 years from step 2 randomization	Overall survival (OS) is defined as the time from randomization to death from any cause. OS is censored at the date of last contact for patients still alive. The Kaplan-Meier estimates were used to characterize the 5-year OS rates.
Secondary	The Impact of Tumor Biological Characteristics on Overall Survival	Assessed at baseline, every 3 months for patients within 2 years of step 2 randomization, every 6 months during 3-5 years from step 2 randomization, and then every 12 months until 10 years from step 2 randomization	Overall survival (OS) is defined as the time from randomization to death from any cause. OS is censored at the date of last contact for patients still alive. The following patient/tumor characteristics were associated with overall survival: * ECOG Performance Status (0, 1, or 2) * Age * Sex (male, female) * Primary tumor site (right-side colon, transverse colon, left-side colon, or other) * Number of regional lymph nodes Hazard ratios with adjustment for other covariates are reported with OS as the outcome variable.
Other	The Association Between Oxaliplatin Exposure, Allelic Variants in Candidate Genes, and Neurotoxicity	Assessed at baseline, every 2 weeks while on treatment, up to 10 years	The association between onset of neurotoxicity and oxaliplatin exposure will be assessed. The difference in neurotoxicity rates between patients with and without a given polymorphism will be evaluated.

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	Disease-free Survival Rate at 5 Years	Assessed every 3 months for patients within 2 years of step 2 randomization, every 6 months during 3-5 years from step 2 randomization, and then every 12 months until 10 years from step 2 randomization	Eligible patients who were registered or randomized at Step 2 were included in this analysis.	Proportion of participants	NUMBER
SECONDARY	Overall Survival Rate at 5 Years	Assessed every 3 months for patients within 2 years of step 2 randomization, every 6 months during 3-5 years from step 2 randomization, and then every 12 months until 10 years from step 2 randomization	Eligible patients who were registered or randomized at Step 2 were included in this analysis.	Proportion of participants	NUMBER
SECONDARY	The Impact of Tumor Biological Characteristics on Overall Survival	Assessed at baseline, every 3 months for patients within 2 years of step 2 randomization, every 6 months during 3-5 years from step 2 randomization, and then every 12 months until 10 years from step 2 randomization	Eligible patients who had advanced to step 2 (Arms A, B and C) and had complete data on patient/tumor characteristics are included.	hazard ratio	NUMBER
OTHER_PRE_SPECIFIED	The Association Between Oxaliplatin Exposure, Allelic Variants in Candidate Genes, and Neurotoxicity	Assessed at baseline, every 2 weeks while on treatment, up to 10 years

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
Disease-free Survival Rate at 5 Years	Arm A (5-FU, Leucovorin, Oxaliplatin)		0.805	95% Confidence Interval 0.766 to 0.846	Proportion of participants
Disease-free Survival Rate at 5 Years	Arm B (5-FU, Leucovorin, Oxaliplatin, Bevacizumab)		0.833	95% Confidence Interval 0.796 to 0.871	Proportion of participants
Disease-free Survival Rate at 5 Years	Arm C (Observation)		0.816	95% Confidence Interval 0.791 to 0.842	Proportion of participants
Overall Survival Rate at 5 Years	Arm A (5-FU, Leucovorin, Oxaliplatin)		0.918	95% Confidence Interval 0.891 to 0.946	Proportion of participants
Overall Survival Rate at 5 Years	Arm B (5-FU, Leucovorin, Oxaliplatin, Bevacizumab)		0.921	95% Confidence Interval 0.895 to 0.948	Proportion of participants
Overall Survival Rate at 5 Years	Arm C (Observation)		0.926	95% Confidence Interval 0.909 to 0.943	Proportion of participants
The Impact of Tumor Biological Characteristics on Overall Survival	Tumor Biological Characteristics and Overall Survival Analysis	Hazard ratio: ECOG performance status of 1 (vs. 0)	1.67	95% Confidence Interval 1.24 to 2.25	hazard ratio
The Impact of Tumor Biological Characteristics on Overall Survival	Tumor Biological Characteristics and Overall Survival Analysis	Hazard ratio: ECOG performance status of 2 (vs. 0)	3.39	95% Confidence Interval 1.36 to 8.44	hazard ratio
The Impact of Tumor Biological Characteristics on Overall Survival	Tumor Biological Characteristics and Overall Survival Analysis	Hazard ratio: Age	1.05	95% Confidence Interval 1.04 to 1.07	hazard ratio
The Impact of Tumor Biological Characteristics on Overall Survival	Tumor Biological Characteristics and Overall Survival Analysis	Hazard ratio: Sex of male (vs. female)	1.71	95% Confidence Interval 1.27 to 2.28	hazard ratio

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow40

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Step 1 Registration (Risk Assessment)	STARTED	Arm A (5-FU, Leucovorin, Oxaliplatin)	460
Step 1 Registration (Risk Assessment)	STARTED	Arm B (5-FU, Leucovorin, Oxaliplatin, Bevacizumab)	458
Step 1 Registration (Risk Assessment)	STARTED	Arm C (Observation)	1,013
Step 1 Registration (Risk Assessment)	STARTED	No Randomization/Registration at Step 2	500
Step 1 Registration (Risk Assessment)	COMPLETED	Arm A (5-FU, Leucovorin, Oxaliplatin)	460
Step 1 Registration (Risk Assessment)	COMPLETED	Arm B (5-FU, Leucovorin, Oxaliplatin, Bevacizumab)	458
Step 1 Registration (Risk Assessment)	COMPLETED	Arm C (Observation)	1,013
Step 1 Registration (Risk Assessment)	COMPLETED	No Randomization/Registration at Step 2	0
Step 1 Registration (Risk Assessment)	NOT COMPLETED	Arm A (5-FU, Leucovorin, Oxaliplatin)	0
Step 1 Registration (Risk Assessment)	NOT COMPLETED	Arm B (5-FU, Leucovorin, Oxaliplatin, Bevacizumab)	0

1 to 10 of 40Source ClinicalTrials.gov

See all 40 participant flow

Adverse events776

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
other	Anemia	Blood and lymphatic system disorders	Arm A (5-FU, Leucovorin, Oxaliplatin)	235	428
other	Anemia	Blood and lymphatic system disorders	Arm B (5-FU, Leucovorin, Oxaliplatin, Bevacizumab)	205	410
other	Anemia	Blood and lymphatic system disorders	Arm C (Observation)		0
other	Anemia	Blood and lymphatic system disorders	No Randomization/Registration at Step 2		0
other	Leukocytes decreased	Investigations	Arm A (5-FU, Leucovorin, Oxaliplatin)	222	428
other	Leukocytes decreased	Investigations	Arm B (5-FU, Leucovorin, Oxaliplatin, Bevacizumab)	174	410
other	Leukocytes decreased	Investigations	Arm C (Observation)		0
other	Leukocytes decreased	Investigations	No Randomization/Registration at Step 2		0
other	Neutrophils decreased	Investigations	Arm A (5-FU, Leucovorin, Oxaliplatin)	184	428
other	Neutrophils decreased	Investigations	Arm B (5-FU, Leucovorin, Oxaliplatin, Bevacizumab)	156	410

1 to 10 of 776Source ClinicalTrials.gov

See all 776 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm A (5-FU, Leucovorin, Oxaliplatin)	73	460
Total, all-cause mortality	Arm B (5-FU, Leucovorin, Oxaliplatin, Bevacizumab)	69	458
Total, all-cause mortality	Arm C (Observation)	145	1,013
Total, all-cause mortality	No Randomization/Registration at Step 2	61	500
Total, other adverse events	Arm A (5-FU, Leucovorin, Oxaliplatin)	399	428
Total, other adverse events	Arm B (5-FU, Leucovorin, Oxaliplatin, Bevacizumab)	388	410
Total, other adverse events	Arm C (Observation)	0	0
Total, other adverse events	No Randomization/Registration at Step 2	0	0
Total, serious adverse events	Arm A (5-FU, Leucovorin, Oxaliplatin)	308	428
Total, serious adverse events	Arm B (5-FU, Leucovorin, Oxaliplatin, Bevacizumab)	292	410

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants2

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	Source
U10CA180820	ECOG-ACRIN Network Group Operations Center	ODwyer, Peter J; SCHNALL, MITCHELL D.	ECOG-ACRIN MEDICAL RESEARCH FOUNDATION	NATIONAL CANCER INSTITUTE	2014 to 2026	NIH RePORTER
U10CA021115	Eastern Cooperative Oncology Group Operations Office	COMIS, ROBERT L	FRONTIER SCI & TECHNOLOGY RSCH FDN, INC	NATIONAL CANCER INSTITUTE	1985 to 2013	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00217737

GET https://conductscience.org/api/trials/v1/NCT00217737/flow?page=2

API reference For AI assistants