Safety Study of Bevacizumab Plus Chemotherapy To Treat Metastatic Colorectal Cancer
Overview
- Phase
- Not Applicable
- Intervention
- bevacizumab
- Conditions
- Metastatic Colorectal Cancer
- Sponsor
- Sun Yat-sen University
- Enrollment
- 600
- Locations
- 7
- Primary Endpoint
- Incidence, nature and severity of adverse events of special interest
- Last Updated
- 12 years ago
Overview
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.
Investigators
Ruihua Xu
vice president of SunYat-sen University Cancer Center,head of medical oncology department
Sun Yat-sen University
Eligibility Criteria
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
Arms & Interventions
Bevacizumab Plus Chemotherapy
Intervention: bevacizumab
Outcomes
Primary Outcomes
Incidence, nature and severity of adverse events of special interest
Time Frame: Four years
Gastrointestinal perforation, thromboembolic event, wound healing complication, bleeding, hypertension and proteinuria
Incidence, nature and severity of bevacizumab related serious adverse events
Time Frame: Four years
Onset time of adverse event associated with bevacizumab
Time Frame: Four years
Laboratory parameters
Time Frame: Four years
Complete blood cell count, electrolytes, hepatic and renal function, coagulation parameters, urinalysis or urine protein
Secondary Outcomes
- Overall survival (OS)(Four years)
- Overall response rate (ORR) of treatment line(Four years)
- Progression-free survival (PFS) of treatment line:(Four years)
- One-year disease-free progression rate of treatment line(One year)
- One-year survival rate of treatment line(One year)
- Overall survival (OS) of treatment line(Four years)