An Observational Study of Continued Bevacizumab Plus Chemotherapy Until First Progression in Participants With Metastatic Colorectal Cancer (CRC) (AVACONT)

Roche

Status: Completed

Conditions: Colorectal Cancer

Treatments: Other: Bevacizumab; Combination Product: Chemotherapy

Study type: Observational

Funder types: Industry

Identifiers

NCT02305615

ML29425

Details and patient eligibility

About

This prospective, multicenter, observational study will investigate the effectiveness and safety of bevacizumab in routine clinical practice in participants with metastatic CRC. Participants are to have initiated first-line treatment with fluoropyrimidine-based doublet chemotherapy plus bevacizumab according to the bevacizumab Summary of Product Characteristics (SmPC).

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with histologically confirmed CRC with metastatic lesion
• Participants having initiated first-line treatment with fluoropyrimidine-based doublet chemotherapy plus bevacizumab according to bevacizumab SmPC
• Participants who previously received a minimum 9 cycles of 5-FU-based or a minimum 6 cycles of capecitabine-based induction doublet chemotherapy (i.e. 5-FU or capecitabine + oxaliplatin or irinotecan) plus bevacizumab
• Disease evaluation showed stable disease, partial response, or complete response according to RECIST within one month

Exclusion criteria

• Contraindication to receive bevacizumab according to the bevacizumab SmPC
• Participants who received more than 10 cycles of 5-FU-based or more than 7 cycles of capecitabine-based induction doublet chemotherapy plus bevacizumab
• Pregnant or lactating women

Trial design

300 participants in 1 patient group

Participants with CRC

Description:

This is an observational study; thus, no intervention or treatment is required by the protocol. During the study, the treatment will be determined according to the treating physician decision. Eligible participants will be observed for safety and efficacy of continued bevacizumab plus fluoropyrimidine-based doublet chemotherapy treatment in routine clinical practice for 1 year.

Treatment:

Combination Product: Chemotherapy

Other: Bevacizumab