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
1 other identifier
observational
351
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2012
Typical duration for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 11, 2012
CompletedFirst Submitted
Initial submission to the registry
October 19, 2012
CompletedFirst Posted
Study publicly available on registry
October 23, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedJuly 31, 2018
June 1, 2017
3.7 years
October 19, 2012
July 27, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival from the time of starting first-line therapy
Start of first line therapy until death (up to approximately 4 years)
Secondary Outcomes (4)
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
Study Arms (1)
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.
Interventions
Bevacizumab will be administered as per approved label.
The protocol does not specify the chemotherapy regimen to be used, the choice of chemotherapy will be at the discretion of treating physician.
Eligibility Criteria
Participants with metastatic colorectal cancer receiving first-line bevacizumab in combination with fluoropyrimidine-based chemotherapy
You may qualify if:
- Participants with histologically confirmed metastatic colorectal cancer who will receive bevacizumab in combination with first-line fluoropyrimidine-based chemotherapy
You may not qualify if:
- Participants not qualified for bevacizumab treatment according to the local label
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Chang Gung Medical Foundation - Chai Yi; Surgery
CHAI YI, 613, Taiwan
Kaohsiung Chang Gung Memorial Hospital; Colorectal Surgery
Kaohsiung City, 00833, Taiwan
Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery
Kaohsiung City, 807, Taiwan
Taichung Veterans General Hospital; Dept of Surgery
Taichung, 407, Taiwan
National Cheng Kung Uni Hospital; Dept of Hematology and Oncology
Tainan, 704, Taiwan
Veterans General Hospital; Division of Oncology
Taipei, 00112, Taiwan
Tri-Service General Hospital; Hematology and Oncology
Taipei, 114, Taiwan
Mackay Memorial Hospital; Department of Surgery, Division of Colon and Rectal Surgery
Taipei, Taiwan
Chang Gung Medical Foundation - Linkou; Colo-rectal Surgery
Taoyuan District, 333, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2012
First Posted
October 23, 2012
Study Start
October 11, 2012
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
July 31, 2018
Record last verified: 2017-06