Status:
UNKNOWN
Safety Study of Bevacizumab Plus Chemotherapy To Treat Metastatic Colorectal Cancer
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Proswell Medical Corporation
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
Brief Summary
To assess the safety profile of bevacizumab in combination with chemotherapy for the treatment of metastatic colorectal cancer
Detailed Description
This is a multi-centre, observational, non-interventional study. Patients with metastatic colorectal cancer eligible for Bevacizumab in combination with chemotherapy treatment will be enrolled in this...
Eligibility Criteria
Inclusion
- with histologically confirmed metastatic colorectal cancer
- patients with metastatic colorectal cancer who are eligible for Bevacizumab in combination with chemotherapy treatment
- Written informed consent
- Unlimited line of treatment (first-line or second line is not limited)
Exclusion
- Patients who are not eligible for Bevacizumab treatment according to locally approved Bevacizumab China package insert will be excluded. The following patients are not eligible for Bevacizumab treatment according to local Bevacizumab China package insert:
- Recent history of serious hemorrhage or hemoptysis of ≥1/2 teaspoon of red blood
- Proteinuria at baseline: Patients discovered to have ≥ 2 grams of proteinuria/24 hours \*
- The measurement of 24-hour proteinuria level is recommended for patients with moderate to high proteinuria risk indicated by clinical judgement. The treatment with bevacizumab should be delayed when proteinuria is ≥2g/24 hours.
- Major surgical procedure within 28 days prior to treatment initiation, or not fully healed wounds
- Pregnant or lactating women
- Excluding patients known to be allergic to bevacizumab or any of the excipients
Key Trial Info
Start Date :
August 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT01912443
Start Date
August 1 2013
Last Update
April 28 2014
Active Locations (7)
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1
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
2
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
3
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
4
Liaoning Cancer Hosptial & Institute
Shenyang, Liaoning, China, 110042