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

Hoffmann-La Roche200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Metastatic Colorectal Cancer

Interventions

No interventionOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (23)

Onze Lieve Vrouwziekenhuis Aalst

Aalst, Belgium

AZ Sint Lucas Brugge

Assebroek, Belgium

Outcomes

Primary Outcomes

Second Progression Free Survival (PFS2) defined as the time interval between study entry and the date of progression or death for any cause, whichever occurs first

Time frame: Up to 3 years

Sarcopenia quantified via CT-scan defined as a skeletal muscle index at the 3rd lumbar vertebra below 41 for women and below 43 or 53 for men with a Body Mass Index below or above 25 respectively

Time frame: Up to 3 years

Secondary Outcomes

Participants body weight at initial diagnosis of mCRC

Time frame: Up to 3 years

Participants body mass index at initial diagnosis of mCRC

Time frame: Up to 3 years

Participants skeletal muscle mass at initial diagnosis of mCRC

Time frame: Up to 3 years

Participants visceral fat mass, subcutaneous fat mass, total fat mass at SE

Time frame: Up to 3 years

Participants Eastern Cooperative Oncology Group Performance status at SE

Time frame: Up to 3 years

Participant muscle strength at initial diagnosis of mCRC

Time frame: Up to 3 years

Participants primary and metastases location at Initial Diagnosis

Time frame: Up to 3 years

Participants mutation status at Initial Diagnosis

Time frame: Up to 3 years

Data from ClinicalTrials.gov

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CHIREC

Auderghem, Belgium

Imeldaziekenhuis

Bonheiden, Belgium

AZ KLINA

Brasschaat, Belgium

AZ Sint Jan

Bruges, Belgium

Institut Jules Bordet X

Brussels, Belgium

Hospital Erasme

Brussels, Belgium

Cliniques Universitaires St-Luc

Brussels, Belgium

Grand Hôpital de Charleroi Notre Dame

Charleroi, Belgium

...and 13 more locations

Participants C-Reactive Protein and Albumin blood values at Initial Diagnosis

Time frame: Up to 3 years

Participants Date of diagnosis of non-metastatic CRC disease at Initial Diagnosis

Time frame: Up to 3 years

Participant with 1st line Chemotherapeutic regimen at Initial Diagnosis

Time frame: Up to 3 years

Functional status using Functional Assessment for Cancer Treatment - specific for Colorectal cancer participants

Time frame: Up to 3 years

Participant Physical status expressed in muscle strength

Time frame: Up to 3 years

Participant Physical status expressed in Body Weight

Time frame: Up to 3 years

Participant Physical status expressed in Body Mass Index

Time frame: Up to 3 years

Nutritional status using the Patient-Generated Subjective Global Assessment questionnaire

Time frame: Up to 3 years

Nutritional status using Visual Analogue Scale for appetite

Time frame: Up to 3 years

Treatment related toxicity using MD Anderson Symptom Inventory scale

Time frame: Up to 3 years

Number of participants with Number of chemotherapy cycles

Time frame: Up to 3 years

Number of participants with Number of bevacizumab administrations

Time frame: Up to 3 years

Number of participants with Treatment changes and treatment (un)changed until Second Progressive Disease

Time frame: Up to 3 years

Number of participants with Reason for treatment changes

Time frame: Up to 3 years

Intake dietary supplements

Time frame: Up to 3 years

Dietary and physical counselling

Time frame: Up to 3 years

Number of Participants with Adverse Events

Time frame: Up to 3 years

First Progression Free Survival (PFS1) is defined as the time between initial diagnosis and first progressive disease

Time frame: Up to 3 years