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

Roche

Status: Completed

Conditions: Colorectal Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT01319877

ML25391

Details and patient eligibility

About

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.

Enrollment: 609 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

609 participants in 2 patient groups

First Line Treatment

Description:

Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.

Second Line Treatment

Description:

Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.