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
• Interventions: Other: No intervention

• 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

Study Timeline

• Study First Submitted: 2016-01-27
• Study First Submitted QC: 2016-02-01
• Study First Posted: 2016-02-04
• Study Start: 2016-03-14
• Primary Completion: 2020-02-04
• Study Completion: 2020-02-04
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-24
• Last Update Posted: 2020-03-25

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with metastatic colorectal cancer	No intervention	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

Primary Outcome Measures

Name	Time	Method
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	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	Up to 3 years

Secondary Outcome Measures

Name	Time	Method
Participants body mass index at initial diagnosis of mCRC	Up to 3 years
Participants skeletal muscle mass at initial diagnosis of mCRC	Up to 3 years
Participants visceral fat mass, subcutaneous fat mass, total fat mass at SE	Up to 3 years
Participants Eastern Cooperative Oncology Group Performance status at SE	Up to 3 years
Participant muscle strength at initial diagnosis of mCRC	Up to 3 years
Participants primary and metastases location at Initial Diagnosis	Up to 3 years
Participants mutation status at Initial Diagnosis	Up to 3 years
Participants C-Reactive Protein and Albumin blood values at Initial Diagnosis	Up to 3 years
Participants Date of diagnosis of non-metastatic CRC disease at Initial Diagnosis	Up to 3 years
Participant with 1st line Chemotherapeutic regimen at Initial Diagnosis	Up to 3 years
Participants body weight at initial diagnosis of mCRC	Up to 3 years
Functional status using Functional Assessment for Cancer Treatment - specific for Colorectal cancer participants	Up to 3 years
Participant Physical status expressed in muscle strength	Up to 3 years
Participant Physical status expressed in Body Weight	Up to 3 years
Participant Physical status expressed in Body Mass Index	Up to 3 years
Nutritional status using the Patient-Generated Subjective Global Assessment questionnaire	Up to 3 years
Nutritional status using Visual Analogue Scale for appetite	Up to 3 years
Treatment related toxicity using MD Anderson Symptom Inventory scale	Up to 3 years
Number of participants with Number of chemotherapy cycles	Up to 3 years
Number of participants with Number of bevacizumab administrations	Up to 3 years
Number of participants with Treatment changes and treatment (un)changed until Second Progressive Disease	Up to 3 years
Number of participants with Reason for treatment changes	Up to 3 years
Intake dietary supplements	Up to 3 years
Dietary and physical counselling	Up to 3 years
Number of Participants with Adverse Events	Up to 3 years
First Progression Free Survival (PFS1) is defined as the time between initial diagnosis and first progressive disease	Up to 3 years

Trial Locations

Locations (23)

Onze Lieve Vrouwziekenhuis Aalst; 🇧🇪 Aalst, Belgium

Jessa Zkh (Campus Salvator); 🇧🇪 Hasselt, Belgium

Grand Hôpital de Charleroi Notre Dame; 🇧🇪 Charleroi, Belgium

AZ Maria Middelares; 🇧🇪 Gent, Belgium

UZ Leuven Gasthuisberg; 🇧🇪 Leuven, Belgium

CHC MontLégia; 🇧🇪 Liege, Belgium

AZ St Maarten Campus Leopoldstr; 🇧🇪 Mechelen, Belgium

Hospital Erasme; 🇧🇪 Bruxelles, Belgium

Hôpital André Vésale; 🇧🇪 Montigny-le-Tilleul, Belgium

AZ Nikolaas (Sint Niklaas); 🇧🇪 Sint Niklaas, Belgium

AZ Sint Jan; 🇧🇪 Brugge, Belgium

Institut Jules Bordet X; 🇧🇪 Brussels, Belgium

CHU Sart-Tilman; 🇧🇪 Liège, Belgium

AZ Turnhout Sint Elisabeth; 🇧🇪 Turnhout, Belgium

Imeldaziekenhuis; 🇧🇪 Bonheiden, Belgium

AZ Damiaan; 🇧🇪 Oostende, Belgium

AZ Delta (Campus Wilgenstraat); 🇧🇪 Roeselare, Belgium

AZ Glorieux- vzw Werken Glorieux; 🇧🇪 Ronse, Belgium

CHIREC; 🇧🇪 Auderghem, Belgium

AZ KLINA; 🇧🇪 Brasschaat, Belgium

Cliniques Universitaires St-Luc; 🇧🇪 Bruxelles, Belgium

CHR de Verviers - East Belgium; 🇧🇪 Verviers, Belgium

AZ Sint Lucas Brugge; 🇧🇪 Assebroek, Belgium