Safety Study of Bevacizumab Plus Chemotherapy To Treat Metastatic Colorectal Cancer
NCT ID: NCT01912443
Last Updated: 2014-04-28
Study Results
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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UNKNOWN
600 participants
OBSERVATIONAL
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Bevacizumab Plus Chemotherapy
bevacizumab
5 mg/Kg, IV (in the vein) on day 1 and day 14 of each 28 day cycle. Number of Cycles: until progression.
Interventions
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bevacizumab
5 mg/Kg, IV (in the vein) on day 1 and day 14 of each 28 day cycle. Number of Cycles: until progression.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
ALL
No
Sponsors
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Proswell Medical Corporation
INDUSTRY
Sun Yat-sen University
OTHER
Responsible Party
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Ruihua Xu
vice president of SunYat-sen University Cancer Center,head of medical oncology department
Locations
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Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Liaoning Cancer Hosptial & Institute
Shenyang, Liaoning, China
The Second People's Hospital of Sichuan
Chengdu, Sichuan, China
First Affiliated Hospital of PLA General Hospital
Beijing, , China
Chinese PLA General Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ML28629
Identifier Type: -
Identifier Source: org_study_id
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