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Completed

NCT Number: NCT01712347

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

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chang Gung Medical Foundation - Chai Yi; Surgery, CHAI YI, Taiwan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bevacizumab

Drug

Bevacizumab will be administered as per approved label.

Other names: Avastin

Chemotherapy

Drug

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

Primary outcomes

  1. Overall survival from the time of starting first-line therapy

    Time frame: Start of first line therapy until death (up to approximately 4 years)

Secondary outcomes

  1. 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

    Time frame: Start of first line therapy until death (up to approximately 4 years)

  2. Percentage of participants with best overall response, assessed according to RECIST v.1.1 criteria

    Time frame: Start of first line therapy until death (up to approximately 4 years)

  3. Percentage of participants with liver resection

    Time frame: up to approximately 4 years

  4. Number of participants with adverse events

    Time frame: up to approximately 4 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Oct 23, 2012
Registry last updated
Jul 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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