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

NCT ID: NCT01775644

Last Updated: 2021-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3003 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-14

Study Completion Date

2019-05-10

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Bevacizumab

Intervention Type DRUG

Administration of treatment will be as used in normal daily routine under local labeling.

Interventions

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Bevacizumab

Administration of treatment will be as used in normal daily routine under local labeling.

Intervention Type DRUG

Other Intervention Names

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Avastin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Countries

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Germany

Other Identifiers

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ML28120

Identifier Type: -

Identifier Source: org_study_id