Trial · NCT01718873

Optimization of Bevacizumab Scheduling With Chemotherapy for Metastatic Colorectal Cancer

NCT01718873, Phase 3, Completed, National Cancer Institute, Naples; results first posted 2023-04-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Optimization of Bevacizumab Scheduling With Chemotherapy for Metastatic Colorectal Cancer. Trials, record NCT01718873. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01718873

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Trial

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

Title: Optimization of Bevacizumab Scheduling With Chemotherapy for Metastatic Colorectal Cancer
NCT number: NCT01718873
Status: Completed
Phases: Phase 3
Enrollment: 230 participants, actual
Lead sponsor: National Cancer Institute, Naples
Conditions: Colorectal Cancer
Interventions: Bevacizumab, Oxaliplatin, levo-folinic acid, 5-fluorouracil, Capecitabine
First posted: 2012-10-31
Last updated: 2023-04-12
Other registries' IDs: eudract:2011-004997-27
Results first posted: 2023-04-12
Limitations and caveats: Considering that the accuracy of conventional evaluation of tumor response by RECIST criteria to bevacizumab combination treatment has been questioned, we acknowledge that our choice of ORR as primary end point may have been inadequate.~We are also aware that balancing out unmeasurable differences in patient outcome through randomization is not always achieved with confidence in trials with a relatively small sample size.

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Objective Response Rate	Objective response was assessed by computed tomographic scan or other appropriate imaging at weeks 12 and 24 from randomization, and every 3 months thereafter, assessed up to 90 months.	Objective response rate (ORR), according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, was the primary end point and was defined as the number of complete plus partial responses divided by the number of enrolled patients. Per RECIST v 1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Secondary	Disease Control Rate	At weeks 12 and 24 from randomization and every 3 months thereafter, assessed up to 90 months	Disease control rate was calculated by adding complete and partial responses and stable disease.
Secondary	Overall Survival	assessed up to 90 months	Overall survival was defined as the time from randomization to the date of death. Patients alive at the time of the final analysis were censored on the date of the last follow-up information available.
Secondary	Progression-free Survival (PFS)	assessed up to 90 months	Progression-free survival was defined as the time from randomization to the date of progression or death, whichever occurred first. Patients without progression were censored on the date of the last follow-up visit. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Secondary	Toxic Effects	up to 4 weeks after the end of the treatment	Toxic effects were scored according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. For the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0 scale score range from 1 to 4. A high score, that is 3 and 4, represents a high level of toxicity, whereas the minimum values, that is 1 and 2, represents a mild/modest level of toxicity.

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Objective Response Rate	Objective response was assessed by computed tomographic scan or other appropriate imaging at weeks 12 and 24 from randomization, and every 3 months thereafter, assessed up to 90 months.		participants	NUMBER
SECONDARY	Disease Control Rate	At weeks 12 and 24 from randomization and every 3 months thereafter, assessed up to 90 months		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Overall Survival	assessed up to 90 months		months	MEDIAN
SECONDARY	Progression-free Survival (PFS)	assessed up to 90 months		months	MEDIAN
SECONDARY	Toxic Effects	up to 4 weeks after the end of the treatment	any grade of toxic effects	Participants	COUNT_OF_PARTICIPANTS

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
Objective Response Rate	Bevacizumab Before Chemotherapy	65	95% Confidence Interval 47.0 to 65.7	participants
Objective Response Rate	Bevacizumab With Chemotherapy	66	95% Confidence Interval 47.8 to 66.6	participants
Disease Control Rate	Bevacizumab Before Chemotherapy	107		Participants
Disease Control Rate	Bevacizumab With Chemotherapy	103		Participants
Overall Survival	Bevacizumab Before Chemotherapy	29.8	95% Confidence Interval 22.5 to 41.1	months
Overall Survival	Bevacizumab With Chemotherapy	24.1	95% Confidence Interval 18.6 to 29.8	months
Progression-free Survival (PFS)	Bevacizumab Before Chemotherapy	11.7	95% Confidence Interval 9.9 to 12.9	months
Progression-free Survival (PFS)	Bevacizumab With Chemotherapy	10.5	95% Confidence Interval 9.1 to 12.3	months
Toxic Effects	Bevacizumab Before Chemotherapy	108		Participants
Toxic Effects	Bevacizumab With Chemotherapy	113		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 Before Chemotherapy	115
Overall Study	STARTED	Bevacizumab With Chemotherapy	115
Overall Study	COMPLETED	Bevacizumab Before Chemotherapy	115
Overall Study	COMPLETED	Bevacizumab With Chemotherapy	115
Overall Study	NOT COMPLETED	Bevacizumab Before Chemotherapy	0
Overall Study	NOT COMPLETED	Bevacizumab With Chemotherapy	0

Source ClinicalTrials.gov

Adverse events82

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	Anemia	Blood and lymphatic system disorders	Bevacizumab Before Chemotherapy	28	115	28
other	Anemia	Blood and lymphatic system disorders	Bevacizumab With Chemotherapy	27	115	27
other	Abdominal pain	Gastrointestinal disorders	Bevacizumab Before Chemotherapy	3	115	3
other	Abdominal pain	Gastrointestinal disorders	Bevacizumab With Chemotherapy	10	115	10
other	Diarrhea	Gastrointestinal disorders	Bevacizumab Before Chemotherapy	27	115	27
other	Diarrhea	Gastrointestinal disorders	Bevacizumab With Chemotherapy	44	115	44
other	Mucositis oral	Infections and infestations	Bevacizumab Before Chemotherapy	26	115	26
other	Mucositis oral	Infections and infestations	Bevacizumab With Chemotherapy	34	115	34
other	Nausea	Gastrointestinal disorders	Bevacizumab Before Chemotherapy	44	115	44
other	Nausea	Gastrointestinal disorders	Bevacizumab With Chemotherapy	44	115	44

1 to 10 of 82Source ClinicalTrials.gov

See all 82 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Bevacizumab Before Chemotherapy	2	115
Total, all-cause mortality	Bevacizumab With Chemotherapy	2	115
Total, other adverse events	Bevacizumab Before Chemotherapy	108	115
Total, other adverse events	Bevacizumab With Chemotherapy	113	115
Total, serious adverse events	Bevacizumab Before Chemotherapy	65	115
Total, serious adverse events	Bevacizumab With Chemotherapy	75	115

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
26857924	DERIVED	PubMed
34309665	DERIVED	PubMed

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 comparisons5

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

Comparison	Source
Bevacizumab Before Chemotherapy vs Bevacizumab With Chemotherapy: Toxic Effects	Trial comparisons
Bevacizumab Before Chemotherapy vs Bevacizumab With Chemotherapy: Objective Response Rate	Trial comparisons
Bevacizumab Before Chemotherapy vs Bevacizumab With Chemotherapy: deaths from any cause	Trial comparisons
Bevacizumab Before Chemotherapy vs Bevacizumab With Chemotherapy: Disease Control Rate	Trial comparisons
Bevacizumab Before Chemotherapy vs Bevacizumab With Chemotherapy: serious adverse events	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/NCT01718873

GET https://conductscience.org/api/trials/v1/NCT01718873/events?page=2

API reference For AI assistants