Observation of Patients With Metastatic Colorectal Cancer Starting Chemotherapy Combined With Bevacizumab (Avastin)

Completed

• Conditions: Metastatic Colorectal Cancer
• Interventions: Other: Observational Chemotherapy; Drug: Concomitant Bevacizumab

• Registration Number: NCT02612077
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This is a longitudinal, multicenter, prospective, pharmacoepidemiological study to evaluate progression free survival (PFS) in a real-life setting in participants with metastatic colorectal cancer (mCRC) starting chemotherapy combined with bevacizumab.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Study First Submitted: 2015-11-19
• Study First Submitted QC: 2015-11-19
• Study First Posted: 2015-11-23
• Results First Submitted: 2016-01-15
• Status Verified: 2016-02
• Results First Submitted QC: 2016-02-12
• Last Update Submitted: 2016-02-12
• Results First Posted: 2016-03-11
• Last Update Posted: 2016-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 765

Inclusion Criteria

• Having colon or rectal metastatic adenocarcinoma, for which the physician decided during the inclusion visit to start a treatment with bevacizumab combined with a 1st, 2nd or 3rd line chemotherapy
• Having received oral and written information about the survey and not objecting to having his/her data computerized

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Exclusion Criteria

• Participating in a clinical trial assessing an anticancer treatment

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational Chemotherapy/Bevacizumab	Observational Chemotherapy	Observed patients receiving chemotherapy with concomitant bevacizumab
Observational Chemotherapy/Bevacizumab	Concomitant Bevacizumab	Observed patients receiving chemotherapy with concomitant bevacizumab

Primary Outcome Measures

Name	Time	Method
Progression-free Survival	within 36 months	Kaplan Meier estimates of median progression-free survival according to the metastatic line of treatment, for a median follow-up of 18, 15 and 13 months, respectively

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Up to 36 months	Overall Survival (OS) was defined as the time between the treatment start (date of the first infusion of bevacizumab) and death from any cause. Kaplan Meier estimates of median overall survival were calculated for the metastatic lines of treatment, with a median follow-up of 18, 15 and 13 months, respectively.
Quality of Life - Global Health Status	Baseline, 6 and 12 months	Participants rated their quality of life (global health status) on the European Organization for Research and Treatment of Cancer 30-item Core Quality of Life Questionnaire (EORTC QLQ C-30), with total scores ranging from 0 (worst) to 100 (best).