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

Sponsor
Hoffmann-La Roche
Study ID
NCT01775644
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    Administration of treatment will be as used in normal daily routine under local labeling.

Study Details

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.

Key Dates

First listed
Jan 25, 2013
Start date
Dec 14, 2012
Status verified
Nov 2021
Primary completion
May 10, 2019
Completion
May 10, 2019

Study Design

Enrollment
3,003 participants (actual)

Arms

  • Arm: Metastatic Colorectal Cancer Participants
    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.

Primary Outcome Measure

Median Progression-Free Survival Time in Defined Participant Subgroups as Assessed by Response Evaluation Criteria In Solid Tumors (RECIST) [ Time Frame: Baseline up to 5 years ]

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