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

Completed
Conditions
Metastatic Colorectal Cancer
Registration Number
NCT02673710
Lead Sponsor
Hoffmann-La Roche
Brief Summary

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

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
200
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 firstUp 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 respectivelyUp to 3 years
Secondary Outcome Measures
NameTimeMethod
Participants body mass index at initial diagnosis of mCRCUp to 3 years
Participants skeletal muscle mass at initial diagnosis of mCRCUp to 3 years
Participants visceral fat mass, subcutaneous fat mass, total fat mass at SEUp to 3 years
Participants Eastern Cooperative Oncology Group Performance status at SEUp to 3 years
Participant muscle strength at initial diagnosis of mCRCUp to 3 years
Participants primary and metastases location at Initial DiagnosisUp to 3 years
Participants mutation status at Initial DiagnosisUp to 3 years
Participants C-Reactive Protein and Albumin blood values at Initial DiagnosisUp to 3 years
Participants Date of diagnosis of non-metastatic CRC disease at Initial DiagnosisUp to 3 years
Participant with 1st line Chemotherapeutic regimen at Initial DiagnosisUp to 3 years
Functional status using Functional Assessment for Cancer Treatment - specific for Colorectal cancer participantsUp to 3 years
Participant Physical status expressed in muscle strengthUp to 3 years
Participant Physical status expressed in Body WeightUp to 3 years
Participant Physical status expressed in Body Mass IndexUp to 3 years
Nutritional status using the Patient-Generated Subjective Global Assessment questionnaireUp to 3 years
Nutritional status using Visual Analogue Scale for appetiteUp to 3 years
Treatment related toxicity using MD Anderson Symptom Inventory scaleUp to 3 years
Number of participants with Number of chemotherapy cyclesUp to 3 years
Number of participants with Number of bevacizumab administrationsUp to 3 years
Number of participants with Treatment changes and treatment (un)changed until Second Progressive DiseaseUp to 3 years
Number of participants with Reason for treatment changesUp to 3 years
Intake dietary supplementsUp to 3 years
Number of Participants with Adverse EventsUp to 3 years
First Progression Free Survival (PFS1) is defined as the time between initial diagnosis and first progressive diseaseUp to 3 years
Participants body weight at initial diagnosis of mCRCUp to 3 years
Dietary and physical counsellingUp to 3 years

Trial Locations

Locations (23)

Onze Lieve Vrouwziekenhuis Aalst

🇧🇪

Aalst, Belgium

AZ Sint Lucas Brugge

🇧🇪

Assebroek, Belgium

CHIREC

🇧🇪

Auderghem, Belgium

Imeldaziekenhuis

🇧🇪

Bonheiden, Belgium

AZ KLINA

🇧🇪

Brasschaat, Belgium

AZ Sint Jan

🇧🇪

Brugge, Belgium

Institut Jules Bordet X

🇧🇪

Brussels, Belgium

Hospital Erasme

🇧🇪

Bruxelles, Belgium

Cliniques Universitaires St-Luc

🇧🇪

Bruxelles, Belgium

Grand Hôpital de Charleroi Notre Dame

🇧🇪

Charleroi, Belgium

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Onze Lieve Vrouwziekenhuis Aalst
🇧🇪Aalst, Belgium

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