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

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: Bevacizumab; Drug: Chemotherapy

• Registration Number: NCT01712347
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-11
• Study First Submitted: 2012-10-19
• Study First Submitted QC: 2012-10-19
• Study First Posted: 2012-10-23
• Primary Completion: 2016-07-01
• Study Completion: 2016-07-01
• Status Verified: 2017-06
• Last Update Submitted: 2018-07-27
• Last Update Posted: 2018-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 351

Inclusion Criteria

• Participants with histologically confirmed metastatic colorectal cancer who will receive bevacizumab in combination with first-line fluoropyrimidine-based chemotherapy

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Exclusion Criteria

• Participants not qualified for bevacizumab treatment according to the local label

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
mCRC Participants	Chemotherapy	mCRC participant will receive bevacizumab as per approved label with the approved first-line fluoropyrimidine based chemotherapy, as per physician discretion. The protocol does not specify the chemotherapy regimen to be used, the choice of chemotherapy will be at the discretion of treating physician.
mCRC Participants	Bevacizumab	mCRC participant will receive bevacizumab as per approved label with the approved first-line fluoropyrimidine based chemotherapy, as per physician discretion. The protocol does not specify the chemotherapy regimen to be used, the choice of chemotherapy will be at the discretion of treating physician.

Primary Outcome Measures

Name	Time	Method
Overall survival from the time of starting first-line therapy	Start of first line therapy until death (up to approximately 4 years)

Secondary Outcome Measures

Name	Time	Method
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	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	Start of first line therapy until death (up to approximately 4 years)
Percentage of participants with liver resection	up to approximately 4 years
Number of participants with adverse events	up to approximately 4 years

Trial Locations

Locations (9)

Chang Gung Medical Foundation - Chai Yi; Surgery; 🇨🇳 Chai Yi, Taiwan

Kaohsiung Chang Gung Memorial Hospital; Colorectal Surgery; 🇨🇳 Kaohsiung, Taiwan

National Cheng Kung Uni Hospital; Dept of Hematology and Oncology; 🇨🇳 Tainan, Taiwan

Tri-Service General Hospital; Hematology and Oncology; 🇨🇳 Taipei, Taiwan

Chang Gung Medical Foundation - Linkou; Colo-rectal Surgery; 🇨🇳 Taoyuan, Taiwan

Taichung Veterans General Hospital; Dept of Surgery; 🇨🇳 Taichung, Taiwan

Veterans General Hospital; Division of Oncology; 🇨🇳 Taipei, Taiwan

Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery; 🇨🇳 Kaohsiung, Taiwan

Mackay Memorial Hospital; Department of Surgery, Division of Colon and Rectal Surgery; 🇨🇳 Taipei, Taiwan