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

An Open-Label, Multicenter, Non-Interventional, Observational Study To Assess The Effect Of First Line Bevacizumab Treatment With Fluoropyrimidine-Based Chemotherapy (CTX) In Patients With Metastatic Colorectal Cancer

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 Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Bevacizumab; Drug: Chemotherapy

• Study Type: Observational
• Enrollment (Actual): 351

Contacts and Locations

Study Locations

• Taiwan
  • Chai Yi, Taiwan, 613
    • Chang Gung Medical Foundation - Chai Yi; Surgery
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery
  • Kaohsiung, Taiwan, 00833
    • Kaohsiung Chang Gung Memorial Hospital; Colorectal Surgery
  • Taichung, Taiwan, 407
    • Taichung Veterans General Hospital; Dept of Surgery
  • Tainan, Taiwan, 704
    • National Cheng Kung Uni Hospital; Dept of Hematology and Oncology
  • Taipei, Taiwan, 114
    • Tri-Service General Hospital; Hematology and Oncology
  • Taipei, Taiwan, 00112
    • Veterans General Hospital; Division of Oncology
  • Taipei, Taiwan
    • Mackay Memorial Hospital; Department of Surgery, Division of Colon and Rectal Surgery
  • Taoyuan, Taiwan, 333
    • Chang Gung Medical Foundation - Linkou; Colo-rectal Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Participants with metastatic colorectal cancer receiving first-line bevacizumab in combination with fluoropyrimidine-based chemotherapy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
mCRC Participants; 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.	Drug: Bevacizumab; Bevacizumab will be administered as per approved label.; Other Names: Avastin; Drug: Chemotherapy; The protocol does not specify the chemotherapy regimen to be used, the choice of chemotherapy will be at the discretion of treating physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2012
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: October 19, 2012
• First Submitted That Met QC Criteria: October 19, 2012
• First Posted (Estimate): October 23, 2012

Study Record Updates

• Last Update Posted (Actual): July 31, 2018
• Last Update Submitted That Met QC Criteria: July 27, 2018
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: ML28233