Safety Study of Bevacizumab Plus Chemotherapy To Treat Metastatic Colorectal Cancer

• Conditions: Metastatic Colorectal Cancer
• Interventions: Drug: bevacizumab

• Registration Number: NCT01912443
• Lead Sponsor: Sun Yat-sen University

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 trial.

Study Timeline

• Study First Submitted: 2013-07-24
• Study First Submitted QC: 2013-07-29
• Study First Posted: 2013-07-31
• Study Start: 2013-08
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-25
• Last Update Posted: 2014-04-28
• Primary Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bevacizumab Plus Chemotherapy	bevacizumab	-

Primary Outcome Measures

Name	Time	Method
Incidence, nature and severity of adverse events of special interest	Four years	Gastrointestinal perforation, thromboembolic event, wound healing complication, bleeding, hypertension and proteinuria
Incidence, nature and severity of bevacizumab related serious adverse events	Four years
Onset time of adverse event associated with bevacizumab	Four years
Laboratory parameters	Four years	Complete blood cell count, electrolytes, hepatic and renal function, coagulation parameters, urinalysis or urine protein

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	Four years	Time from the diagnosis of colorectal cancer to death due to various causes. Patients who do not die at the end of study will be truncated when they do not die at the last collection.
Overall response rate (ORR) of treatment line	Four years	The best overall response status determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria is defined as the best response status recorded from the enrollment to disease progression (the minimal measurement from baseline assessment is used as the reference for progression). ORR includes complete response (CR) and partial response (PR). The value of change will be summarized according to different treatment lines.
Progression-free survival (PFS) of treatment line:	Four years	Time from the enrollment to disease progression or death due to various causes, whichever is earlier (Disease progression is according to RECIST 1.1 criteria for tumor assessment). Patients who do not have disease progression or death at the end of study will be truncated at the last tumor assessment. The value of change will be summarized according to different treatment lines.
One-year disease-free progression rate of treatment line	One year	The proportion of patients without disease progression within one year since enrollment or with death for other reasons based on analytical population. The value of change will be summarized according to different treatment lines.
One-year survival rate of treatment line	One year	The proportion of patients without death within one year since enrollment based on analytical population. The value of change will be summarized according to different treatment lines.
Overall survival (OS) of treatment line	Four years	Time from the enrollment to death due to various causes. Patients who do not die at the end of study will be truncated when they do not die at the last collection.

Trial Locations

Locations (7)

The Second People's Hospital of Sichuan; 🇨🇳 Chengdu, Sichuan, China

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Chinese PLA General Hospital; 🇨🇳 Beijing, China

First Affiliated Hospital of PLA General Hospital; 🇨🇳 Beijing, China

Liaoning Cancer Hosptial & Institute; 🇨🇳 Shenyang, Liaoning, China

Sun Yat-Sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China