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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01712347
• Other study ID #: ML28233
• Status: Completed
• Start date: October 11, 2012
• Est. completion date: July 1, 2016

Study information

• Verified date: June 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: July 1, 2016
• Est. primary completion date: July 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Bevacizumab
Bevacizumab will be administered as per approved label.
• Chemotherapy
The protocol does not specify the chemotherapy regimen to be used, the choice of chemotherapy will be at the discretion of treating physician.

Locations

Country	Name	City	State
Taiwan	Chang Gung Medical Foundation - Chai Yi; Surgery	Chai Yi
Taiwan	Kaohsiung Chang Gung Memorial Hospital; Colorectal Surgery	Kaohsiung
Taiwan	Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery	Kaohsiung
Taiwan	Taichung Veterans General Hospital; Dept of Surgery	Taichung
Taiwan	National Cheng Kung Uni Hospital; Dept of Hematology and Oncology	Tainan
Taiwan	Mackay Memorial Hospital; Department of Surgery, Division of Colon and Rectal Surgery	Taipei
Taiwan	Tri-Service General Hospital; Hematology and Oncology	Taipei
Taiwan	Veterans General Hospital; Division of Oncology	Taipei
Taiwan	Chang Gung Medical Foundation - Linkou; Colo-rectal Surgery	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival from the time of starting first-line therapy		Start of first line therapy until death (up to approximately 4 years)
Secondary	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)
Secondary	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)
Secondary	Percentage of participants with liver resection		up to approximately 4 years
Secondary	Number of participants with adverse events		up to approximately 4 years