Trial · NCT00321828

Combination Chemotherapy and Bevacizumab in Treating Patients With Stage IV Colon Cancer That Cannot Be Removed By Surgery

NCT00321828, Phase 2, Completed, NSABP Foundation Inc; results first posted 2013-01-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Combination Chemotherapy and Bevacizumab in Treating Patients With Stage IV Colon Cancer That Cannot Be Removed By Surgery. Trials, record NCT00321828. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00321828

On this page

Trial

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

Title: Combination Chemotherapy and Bevacizumab in Treating Patients With Stage IV Colon Cancer That Cannot Be Removed By Surgery
NCT number: NCT00321828
Status: Completed
Phases: Phase 2
Enrollment: 90 participants, actual
Lead sponsor: NSABP Foundation Inc
Conditions: Colorectal Cancer
Interventions: bevacizumab, fluorouracil, leucovorin, oxaliplatin
First posted: 2006-05-04
Last updated: 2024-03-21
Results first posted: 2013-01-14

Source ClinicalTrials.gov

Registered outcomes7

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

List	Outcome	Time frame	Description
Primary	Major Morbidity Related to the Intact Primary Tumor	24 months	Cumulative incidence was used to compute percent probability of morbidity. Cumulative incidence at time t measures the probability of a participant having an event (i.e., Colonic bleeding, perforation, bowel obstruction, or fistula formation requiring surgery or resulting in patient death) over the given duration, t. It involves computing the probability of an event at any observed time (i.e., the number of new cases during a period divided by the number of subjects at risk) and multiplying these successive probabilities by any early computed probability to get the final estimate.
Secondary	Local Complications as Assessed by Colonic Obstruction Requiring Hospitalization (But Not Surgery) for Medical Management, Stent Placement, Laser Treatment, or Fulguration	Time from start of study through year 5
Secondary	Local Complications as Assessed by Gastrointestinal Bleeding Requiring Transfusion But Not Requiring Surgery	Time from start of study through year 5
Secondary	Local Complications as Assessed by Fistula Formation (Self-draining Enterocutaneous Fistula and Intra-abdominal Abscess Requiring Percutaneous Drainage) Not Requiring Surgery	Time from start of study through year 5
Secondary	Local Complications as Assessed by Other Events Related to the Intact Primary Tumor Which Require Hospitalization But Not Surgery	Time from start of study through year 5
Secondary	Serious Adverse Events (Grades 3, 4, and 5) as Defined by CTCAE v3.0	Time from start of study through year 5
Secondary	Overall Survival as Measured by Death From Any Cause	Time from start of study through year 5

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Major Morbidity Related to the Intact Primary Tumor	24 months	probability of major morbidity (%)	NUMBER
SECONDARY	Local Complications as Assessed by Colonic Obstruction Requiring Hospitalization (But Not Surgery) for Medical Management, Stent Placement, Laser Treatment, or Fulguration	Time from start of study through year 5
SECONDARY	Local Complications as Assessed by Gastrointestinal Bleeding Requiring Transfusion But Not Requiring Surgery	Time from start of study through year 5
SECONDARY	Local Complications as Assessed by Fistula Formation (Self-draining Enterocutaneous Fistula and Intra-abdominal Abscess Requiring Percutaneous Drainage) Not Requiring Surgery	Time from start of study through year 5
SECONDARY	Local Complications as Assessed by Other Events Related to the Intact Primary Tumor Which Require Hospitalization But Not Surgery	Time from start of study through year 5
SECONDARY	Serious Adverse Events (Grades 3, 4, and 5) as Defined by CTCAE v3.0	Time from start of study through year 5
SECONDARY	Overall Survival as Measured by Death From Any Cause	Time from start of study through year 5

Source ClinicalTrials.gov

Results by group1

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Major Morbidity Related to the Intact Primary Tumor	Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab		16.3	95% Confidence Interval 7.6 to 25.1	probability of major morbidity (%)

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab	90
Overall Study	COMPLETED	Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab	86
Overall Study	NOT COMPLETED	Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab	4

Source ClinicalTrials.gov

Adverse events14

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	Abdominal pain	Gastrointestinal disorders	Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab	6	89
other	Anaphylaxis	Immune system disorders	Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab	9	89
other	Anemia	Blood and lymphatic system disorders	Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab	5	89
other	Anorexia	Metabolism and nutrition disorders	Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab	5	89
other	Dehydration	Metabolism and nutrition disorders	Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab	7	89
other	Diarrhea	Gastrointestinal disorders	Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab	7	89
other	Dyspnea	Respiratory, thoracic and mediastinal disorders	Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab	8	89
other	Fatigue	General disorders	Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab	14	89
other	Nausea	Gastrointestinal disorders	Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab	6	89
other	Neutrophil count decreased	Investigations	Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab	29	89

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
Total, other adverse events	Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab	58	89
Total, serious adverse events	Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab	1	89

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 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/NCT00321828

GET https://conductscience.org/api/trials/v1/NCT00321828/registered

API reference For AI assistants