Trial · NCT00623805

A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) as Maintenance Treatment in Patients With Metastatic Colorectal Cancer

NCT00623805, Phase 3, Completed, Hoffmann-La Roche; results first posted 2014-08-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) as Maintenance Treatment in Patients With Metastatic Colorectal Cancer. Trials, record NCT00623805. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00623805

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Trial

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

Title: A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) as Maintenance Treatment in Patients With Metastatic Colorectal Cancer
NCT number: NCT00623805
Status: Completed
Phases: Phase 3
Enrollment: 123 participants, actual
Lead sponsor: Hoffmann-La Roche
Conditions: Colorectal Cancer
Interventions: Bevacizumab, Capecitabine, Oxaliplatin
First posted: 2008-02-26
Last updated: 2014-08-08
Results first posted: 2014-08-08

Source ClinicalTrials.gov

Registered outcomes7

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

List	Outcome	Time frame	Description
Primary	Progression-free Survival	Baseline to the end of the study (up to 4 years, 2 months)	Progression-free survival was defined as the time from the first administration of study drug to the first documented disease progression or death, whichever occurs first. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.
Secondary	Overall Survival	Baseline to the end of the study (up to 4 years, 2 months)	Overall survival was defined as the time from the first administration of study drug to death.
Secondary	Percentage of Participants With a Complete Response or a Partial Response	Baseline to the end of the study (up to 4 years, 2 months)	A complete response was defined as the disappearance of all target lesions. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the Baseline sum longest diameter. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.
Secondary	Time Until a Complete Response or a Partial Response	Baseline to Month 13	Time until a complete response or a partial response was defined as the time from the first administration of study drug until the first complete response or partial response.
Secondary	Duration of Response	Baseline to the end of the study (up to 4 years, 2 months)	Duration of response was defined as the time from the first complete response or partial response until disease progression or death. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.
Secondary	Percentage of Participants With Metastatic Lesions Previously Considered Inoperable Who Became Operable and Underwent Surgery	Baseline to the end of the study (up to 4 years, 2 months)
Secondary	Percentage of Participants With a R0 Resection	Baseline to the end of the study (up to 4 years, 2 months)	An R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.

Source ClinicalTrials.gov

Outcomes7

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression-free Survival	Baseline to the end of the study (up to 4 years, 2 months)	Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment.	Months	MEAN
SECONDARY	Overall Survival	Baseline to the end of the study (up to 4 years, 2 months)	Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment.	Months	MEAN
SECONDARY	Percentage of Participants With a Complete Response or a Partial Response	Baseline to the end of the study (up to 4 years, 2 months)	Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment.	Percentage of participants	NUMBER
SECONDARY	Time Until a Complete Response or a Partial Response	Baseline to Month 13	Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment. Only participants with a complete response or a partial response were included in the analysis.	Months	MEAN
SECONDARY	Duration of Response	Baseline to the end of the study (up to 4 years, 2 months)
SECONDARY	Percentage of Participants With Metastatic Lesions Previously Considered Inoperable Who Became Operable and Underwent Surgery	Baseline to the end of the study (up to 4 years, 2 months)	Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment.	Percentage of participants	NUMBER
SECONDARY	Percentage of Participants With a R0 Resection	Baseline to the end of the study (up to 4 years, 2 months)

Source ClinicalTrials.gov

Results by group10

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

Outcome	Group	Value	Spread	Units
Progression-free Survival	Bevacizumab+Capecitabine+Oxaliplatin	9.0	Standard Error 0.7	Months
Progression-free Survival	Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C	12.6	Standard Error 1.0	Months
Overall Survival	Bevacizumab+Capecitabine+Oxaliplatin	21.0	Standard Error 1.3	Months
Overall Survival	Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C	25.4	Standard Error 1.7	Months
Percentage of Participants With a Complete Response or a Partial Response	Bevacizumab+Capecitabine+Oxaliplatin	53.2		Percentage of participants
Percentage of Participants With a Complete Response or a Partial Response	Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C	59.0		Percentage of participants
Time Until a Complete Response or a Partial Response	Bevacizumab+Capecitabine+Oxaliplatin	3.5	Standard Deviation 2.8	Months
Time Until a Complete Response or a Partial Response	Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C	2.9	Standard Deviation 2.0	Months
Percentage of Participants With Metastatic Lesions Previously Considered Inoperable Who Became Operable and Underwent Surgery	Bevacizumab+Capecitabine+Oxaliplatin	58.1		Percentage of participants
Percentage of Participants With Metastatic Lesions Previously Considered Inoperable Who Became Operable and Underwent Surgery	Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C	54.1		Percentage of participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Bevacizumab+Capecitabine+Oxaliplatin	62
Overall Study	STARTED	Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C	61
Overall Study	COMPLETED	Bevacizumab+Capecitabine+Oxaliplatin	42
Overall Study	COMPLETED	Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C	39
Overall Study	NOT COMPLETED	Bevacizumab+Capecitabine+Oxaliplatin	20
Overall Study	NOT COMPLETED	Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C	22

Source ClinicalTrials.gov

Adverse events66

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	Nausea	Gastrointestinal disorders	Bevacizumab+Capecitabine+Oxaliplatin	27	62
other	Nausea	Gastrointestinal disorders	Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C	17	61
other	Vomiting	Gastrointestinal disorders	Bevacizumab+Capecitabine+Oxaliplatin	24	62
other	Vomiting	Gastrointestinal disorders	Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C	16	61
other	Weakness	General disorders	Bevacizumab+Capecitabine+Oxaliplatin	24	62
other	Weakness	General disorders	Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C	18	61
other	Anorexia	Gastrointestinal disorders	Bevacizumab+Capecitabine+Oxaliplatin	17	62
other	Anorexia	Gastrointestinal disorders	Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C	13	61
other	Diarrhea	Gastrointestinal disorders	Bevacizumab+Capecitabine+Oxaliplatin	24	62
other	Diarrhea	Gastrointestinal disorders	Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C	17	61

1 to 10 of 66Source ClinicalTrials.gov

See all 66 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Bevacizumab+Capecitabine+Oxaliplatin
Total, all-cause mortality	Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C
Total, other adverse events	Bevacizumab+Capecitabine+Oxaliplatin	62	62
Total, other adverse events	Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C	61	61
Total, serious adverse events	Bevacizumab+Capecitabine+Oxaliplatin	12	62
Total, serious adverse events	Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C	21	61

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

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.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Bevacizumab+Capecitabine+Oxaliplatin vs Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C: 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.

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/NCT00623805

GET https://conductscience.org/api/trials/v1/NCT00623805/events?page=2

API reference For AI assistants