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

NCT ID: NCT01712347

Last Updated: 2018-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

351 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-11

Study Completion Date

2016-07-01

Brief Summary

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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

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Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Bevacizumab

Intervention Type DRUG

Bevacizumab will be administered as per approved label.

Chemotherapy

Intervention Type DRUG

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

Interventions

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Bevacizumab

Bevacizumab will be administered as per approved label.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Avastin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Chang Gung Medical Foundation - Chai Yi; Surgery

CHAI YI, , Taiwan

Site Status

Kaohsiung Chang Gung Memorial Hospital; Colorectal Surgery

Kaohsiung City, , Taiwan

Site Status

Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery

Kaohsiung City, , Taiwan

Site Status

Taichung Veterans General Hospital; Dept of Surgery

Taichung, , Taiwan

Site Status

National Cheng Kung Uni Hospital; Dept of Hematology and Oncology

Tainan City, , Taiwan

Site Status

Veterans General Hospital; Division of Oncology

Taipei, , Taiwan

Site Status

Tri-Service General Hospital; Hematology and Oncology

Taipei, , Taiwan

Site Status

Mackay Memorial Hospital; Department of Surgery, Division of Colon and Rectal Surgery

Taipei, , Taiwan

Site Status

Chang Gung Medical Foundation - Linkou; Colo-rectal Surgery

Taoyuan District, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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ML28233

Identifier Type: -

Identifier Source: org_study_id

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