An Observational Study of First-Line Bevacizumab (Avastin) With Fluoropyrimidine-Based Chemotherapy in Participants With Metastatic Colorectal Cancer

Hoffmann-La Roche351 enrolled

Overview

This multicenter observational study will evaluate the efficacy and safety of first-line bevacizumab (Avastin) in combination with fluoropyrimidine-based chemotherapy in participants with metastatic colorectal cancer (mCRC). Participants for whom the treating physician has decided to initiate first-line fluoropyrimidine based chemotherapy in combination with bevacizumab will be observed for approximately 4 years.

Study Type

OBSERVATIONAL

Enrollment

351

Conditions

Colorectal Cancer

Interventions

BevacizumabDRUG

Bevacizumab will be administered as per approved label.

ChemotherapyDRUG

The protocol does not specify the chemotherapy regimen to be used, the choice of chemotherapy will be at the discretion of treating physician.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants with histologically confirmed metastatic colorectal cancer who will receive bevacizumab in combination with first-line fluoropyrimidine-based chemotherapy Exclusion Criteria: * Participants not qualified for bevacizumab treatment according to the local label

Locations (9)

Chang Gung Medical Foundation - Chai Yi; Surgery

CHAI YI, Taiwan

Kaohsiung Chang Gung Memorial Hospital; Colorectal Surgery

Kaohsiung City, Taiwan

Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery

Kaohsiung City, Taiwan

Outcomes

Primary Outcomes

Overall survival from the time of starting first-line therapy

Time frame: Start of first line therapy until death (up to approximately 4 years)

Secondary Outcomes

Progression-free survival from the time of starting first-line therapy, assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria

Time frame: Start of first line therapy until death (up to approximately 4 years)

Percentage of participants with best overall response, assessed according to RECIST v.1.1 criteria

Time frame: Start of first line therapy until death (up to approximately 4 years)

Percentage of participants with liver resection

Time frame: up to approximately 4 years

Number of participants with adverse events

Time frame: up to approximately 4 years

Data from ClinicalTrials.gov

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