A Study to Assess the Impact of Sarcopenia on the Outcomes of Colorectal Cancer Patients Treated With Chemotherapy Combined With Bevacizumab

NCT ID: NCT02673710

Last Updated: 2020-03-25

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

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-14

Study Completion Date

2020-02-04

Brief Summary

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The purpose of this study is to explore the relationship between sarcopenia, as defined by computed tomography, treatment related outcomes and other body composition related parameters in a patient population receiving bevacizumab beyond progression.

Detailed Description

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Conditions

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Metastatic Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Participants with metastatic colorectal cancer

Participants diagnosed with mCRC treated in first line with a combination of bevacizumab and chemotherapy for whom it is decided to continue the administration of bevacizumab beyond progression while changing CTR will be included in this study

No intervention

Intervention Type OTHER

Besides participant reported outcomes and a muscle strength test no interventions are administered, all treatment decisions are at the discretion of the physician and will be in line with local clinical practice and labeling

Interventions

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No intervention

Besides participant reported outcomes and a muscle strength test no interventions are administered, all treatment decisions are at the discretion of the physician and will be in line with local clinical practice and labeling

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients treated in first line with bevacizumab for whom it is decided, and who are clinically considered eligible, to continue the treatment with bevacizumab beyond PD1.
* Women of childbearing potential have to use effective contraception during (and up to 6 months after) treatment.
* Availability of specific retrospective data at diagnosis and during 1st line treatment

Exclusion Criteria

* Patients who are participating or participated in first line in any other interventional clinical trial involving non-standard of care procedures impacting the body composition
* Dementia or another mental condition making it impossible to fill out questionnaires
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

Locations

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Onze Lieve Vrouwziekenhuis Aalst

Aalst, , Belgium

Site Status

AZ Sint Lucas Brugge

Assebroek, , Belgium

Site Status

CHIREC

Auderghem, , Belgium

Site Status

Imeldaziekenhuis

Bonheiden, , Belgium

Site Status

AZ KLINA

Brasschaat, , Belgium

Site Status

AZ Sint Jan

Bruges, , Belgium

Site Status

Institut Jules Bordet X

Brussels, , Belgium

Site Status

Hospital Erasme

Brussels, , Belgium

Site Status

Cliniques Universitaires St-Luc

Brussels, , Belgium

Site Status

Grand Hôpital de Charleroi Notre Dame

Charleroi, , Belgium

Site Status

AZ Maria Middelares

Ghent, , Belgium

Site Status

Jessa Zkh (Campus Salvator)

Hasselt, , Belgium

Site Status

UZ Leuven Gasthuisberg

Leuven, , Belgium

Site Status

CHC MontLégia

Liège, , Belgium

Site Status

CHU Sart-Tilman

Liège, , Belgium

Site Status

AZ St Maarten Campus Leopoldstr

Mechelen, , Belgium

Site Status

Hôpital André Vésale

Montigny-le-Tilleul, , Belgium

Site Status

AZ Damiaan

Ostend, , Belgium

Site Status

AZ Delta (Campus Wilgenstraat)

Roeselare, , Belgium

Site Status

AZ Glorieux- vzw Werken Glorieux

Ronse, , Belgium

Site Status

AZ Nikolaas (Sint Niklaas)

Sint-Niklaas, , Belgium

Site Status

AZ Turnhout Sint Elisabeth

Turnhout, , Belgium

Site Status

CHR de Verviers - East Belgium

Verviers, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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ML29985

Identifier Type: -

Identifier Source: org_study_id

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