An Observational Study of Avastin in Participants With Metastatic Colorectal Cancer (KORALLE)

Roche

Status: Completed

Conditions: Colorectal Cancer

Treatments: Drug: Bevacizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT01775644

ML28120

Details and patient eligibility

About

This observational multicenter study will evaluate the differences in progression-free survival defined in specific subgroups of participants with metastatic colorectal cancer receiving bevacizumab (Avastin). Further, safety and efficacy in daily routine will be assessed.

Enrollment: 3,003 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with metastatic colorectal cancer where physician has decided to give a first-line, fluoro-pyrimidine-based combination therapy with bevacizumab according to Summary of Product Characteristics (SmPC)

Exclusion criteria

• Contraindications for bevacizumab according to SmPC

Trial design

3,003 participants in 1 patient group

Metastatic Colorectal Cancer Participants

Description:

Administration of treatment will be as used in normal daily routine under local labelling in 4 subgroups- participants with liver and/or lung metastases, potentially resectable after a response to a systemic therapy and clinically operable; participants with tumor related symptoms, risks for complications or fast progression for whom quick proliferation control is needed; "asymptomatic" participants (indolent tumor) without the option of a metastases resection (no pressure for remission) for whom the aim of the therapy is proliferation control and participants without classification.

Treatment:

Drug: Bevacizumab