An Observational Study of Bevacizumab in Chinese Patients With Metastatic Colorectal Cancer

May 17, 2015 updated by: Shen Lin, Peking University
This observational, multicenter, prospective study will evaluate the use of bevacizumab in real clinical practice in chinese patients with metastatic colorectal cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

metastatic colorectal cancer patients accept bevacizumab

Description

Inclusion Criteria:

  • histologically confirmed metastatic colorectal cancer patients Having initiated treatment with bevacizumab

Exclusion Criteria:

  • non-metastatic colorectal cancer patients not recieved bevacizumab

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
bevacizumab
Patients with metastatic colorectal cancer who accept treatment with chemotherapy and bevacizumab
Drug: Bevacizumab
Other Names:
  • avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: 6 weeks
To evaluate the treatment response of bevacizumab in Chinese patients with mCRC in real clinical practice
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 3 months
OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 3 months till death or lost
3 months
progression free survival
Time Frame: 6 weeks
the follow-up visit of PFS will be performed every 6 weeks
6 weeks
Proportion of patients with bevacizumab treatment discontinuation
Time Frame: 3 weeks
Proportion of patients with bevacizumab treatment discontinuation due to bevacizumab-related adverse events
3 weeks
resection rate
Time Frame: 1 month
resection rate of tumor after chemotherapy plus bevacizumab
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Investigators

  • Principal Investigator: Lin Shen, M.D., Beijing Cancer Hopital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

May 19, 2013

First Submitted That Met QC Criteria

May 21, 2013

First Posted (Estimate)

May 22, 2013

Study Record Updates

Last Update Posted (Estimate)

May 19, 2015

Last Update Submitted That Met QC Criteria

May 17, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGOG2001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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