Safety Study of Bevacizumab Plus Chemotherapy To Treat Metastatic Colorectal Cancer

NCT ID: NCT01912443

Last Updated: 2014-04-28

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

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Brief Summary

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To assess the safety profile of bevacizumab in combination with chemotherapy for the treatment of metastatic colorectal cancer

Detailed Description

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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 trial.

Conditions

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Metastatic Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Bevacizumab Plus Chemotherapy

bevacizumab

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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Avastin

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Proswell Medical Corporation

INDUSTRY

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Ruihua Xu

vice president of SunYat-sen University Cancer Center,head of medical oncology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Site Status RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status RECRUITING

Liaoning Cancer Hosptial & Institute

Shenyang, Liaoning, China

Site Status RECRUITING

The Second People's Hospital of Sichuan

Chengdu, Sichuan, China

Site Status RECRUITING

First Affiliated Hospital of PLA General Hospital

Beijing, , China

Site Status RECRUITING

Chinese PLA General Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ruihua Xu, Professor

Role: CONTACT

+86-20-87343804

Facility Contacts

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Jianjun Yang, Doctor

Role: primary

Shuna Yao, Doctor

Role: backup

Qingxia Fan, Doctor

Role: primary

Wei He, Doctor

Role: backup

Baoli Qin, Doctor

Role: primary

Zhongmiao Wang, Master

Role: backup

Jin Yan, Bachelor degree

Role: primary

Yangchun Zheng, Doctor

Role: backup

Nan Du, Doctor

Role: primary

Nan Qi, Doctor

Role: backup

Guanghai Dai, Master

Role: primary

Hui Mao, Doctor

Role: backup

Other Identifiers

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ML28629

Identifier Type: -

Identifier Source: org_study_id

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