An Observational Study of Bevacizumab in Combination With 5-FU-Based Chemotherapy in Chinese Participants With Metastatic Colorectal Cancer

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT01319877
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-18
• Study First Submitted QC: 2011-03-21
• Study First Posted: 2011-03-22
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Results First Submitted: 2016-04-21
• Status Verified: 2016-07
• Results First Submitted QC: 2016-07-22
• Last Update Submitted: 2016-07-22
• Results First Posted: 2016-09-07
• Last Update Posted: 2016-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 609

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events of Special Interest	36 months
Percentage of Participants With Serious Adverse Events	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	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	36 months
Percentage of Participants With Bevacizumab-related Serious Adverse Events	36 months

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival	36 months	Progression-free-survival (PFS) was defined as the time from the date when the participant signed the informed consent form to the time of first documented disease progression or death, whichever occurred first.
Percentage of Participants Achieving an Overall Response by the Chemotherapy Regimen Subgroup	Up to 36 Months	Overall response was defined as complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, all non-target lesions, and no new lesions. PR: At least a 30% decrease in the sum of the diameters of target lesions, no progression in non-target lesions, and no new lesions. Results are reported per participants' chemotherapy regimen subgroup.
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	Overall response was defined as complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, all non-target lesions, and no new lesions. PR: At least a 30% decrease in the sum of the diameters of target lesions, no progression in non-target lesions, and no new lesions.
One-year Survival Rate	1 year
One-year Progression-free Survival Rate	1 year	One year progression-free survival rate was defined as the percentage of participants who were free of progression or death from the date when the participant signed the informed consent form to one year.
Percentage of Participants Achieving an Overall Response Per Kirsten Rat Sarcoma Viral (KRAS) Oncogene Subgroup	36 months	Overall response was defined as complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, all non-target lesions, and no new lesions. PR: At least a 30% decrease in the sum of the diameters of target lesions, no progression in non-target lesions, and no new lesions. Results are reported per participants' Kirsten Rat Sarcoma Viral (KRAS) oncogene subgroup.
One-year Progression-free Survival Rate Per KRAS Subgroup	1 year	One year progression-free survival rate was defined as the percentage of participants who were free of progression or death from the date when the participant signed the informed consent form to one year. Results are reported per participants' Kirsten Rat Sarcoma Viral (KRAS) oncogene subgroup.
One-year Progression-free Survival Rate Per Chemotherapy Regimen Subgroup	1 year	One year progression-free survival rate was defined as the percentage of participants who were free of progression or death from the date when the participant signed the informed consent form to one year. Results are reported per participants' chemotherapy regimen subgroup.
Quality of Life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire	Up to 36 Months	Quality of life was assessed at baseline and every three months after treatment by the EORTC QLQ-C30 questionnaire. The possible score range was 0 to 100, with a higher score indicating better functioning.