A Multi-center Observational Study of Bevacizumab Plus 5-FU Based Chemotherapy as First Line and Second Line Treatment for Chinese Patients With Metastatic Colorectal Cancer (ML25391)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 609
- Primary Endpoint
- Percentage of Participants With Adverse Events of Special Interest
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This observational study will evaluate the safety and efficacy of Bevacizumab in combination with 5-Fluorouracil based chemotherapy as first-line and second-line therapy in Chinese participants with metastatic colorectal cancer. Data will be collected from each participant for up to 3 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult Chinese participants, \>/= 18 years of age
- •Histologically confirmed and previously untreated metastatic colorectal cancer
- •Initiated on treatment with Bevacizumab (in combination with 5-FU based chemotherapy) according to locally approved Bevacizumab China package insert
- •Documented participant with medical records
Exclusion Criteria
- •Recent history of serious hemorrhage or hemoptysis of \>/= 1/2 teaspoon of red blood
- •Proteinuria at baseline (\>/=2 grams / 24 hours)
- •Major surgical procedure within 28 days prior to study treatment start, not fully healed wounds
- •Pregnant or lactating women
Outcomes
Primary Outcomes
Percentage of Participants With Adverse Events of Special Interest
Time Frame: 36 months
Percentage of Participants With Serious Adverse Events
Time Frame: 36 months
A Serious Adverse Event (SAE) was any untoward medical occurrence that at any dose was fatal, required inpatient hospitalization or prolongation of an existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant, or required intervention to prevent one or other of the outcomes listed above.
Percentage of Participants With Adverse Events
Time Frame: 36 months
An adverse event (AE) is defined as any untoward medical occurrence in a participant after administration of a pharmaceutical product and which did not necessarily have a causal relationship with this treatment.
Percentage of Participants With Bevacizumab-Related Adverse Events
Time Frame: 36 months
Percentage of Participants With Bevacizumab-related Serious Adverse Events
Time Frame: 36 months
Secondary Outcomes
- Progression-free Survival(36 months)
- Percentage of Participants Achieving an Overall Response by the Chemotherapy Regimen Subgroup(Up to 36 Months)
- One-year Survival Rate by the Chemotherapy Regimen Subgroup(1 year)
- One-year Survival Rate by the KRAS Subgroup(1 year)
- Percentage of Participants Achieving an Overall Response(36 months)
- One-year Survival Rate(1 year)
- One-year Progression-free Survival Rate(1 year)
- Percentage of Participants Achieving an Overall Response Per Kirsten Rat Sarcoma Viral (KRAS) Oncogene Subgroup(36 months)
- One-year Progression-free Survival Rate Per KRAS Subgroup(1 year)
- One-year Progression-free Survival Rate Per Chemotherapy Regimen Subgroup(1 year)
- Quality of Life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire(Up to 36 Months)