A Study to Assess the Impact of Sarcopenia on the Outcomes of Colorectal Cancer Patients Treated With Chemotherapy Combined With Bevacizumab
A Multicenter Non-Interventional Study Exploring the Impact of Sarcopenia on the Outcomes of Colorectal Cancer Patients Treated With a Chemotherapy Combined With Bevacizumab
1 other identifier
observational
200
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2016
Longer than P75 for all trials
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2016
CompletedFirst Posted
Study publicly available on registry
February 4, 2016
CompletedStudy Start
First participant enrolled
March 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 4, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 4, 2020
CompletedMarch 25, 2020
March 1, 2020
3.9 years
January 27, 2016
March 24, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (26)
Participants body weight at initial diagnosis of mCRC
Up to 3 years
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
- +21 more secondary outcomes
Study Arms (1)
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
Interventions
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 Criteria
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 chemotherapy regimen (CTR) will be included in this study
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Onze Lieve Vrouwziekenhuis Aalst
Aalst, 9300, Belgium
AZ Sint Lucas Brugge
Assebroek, 8310, Belgium
CHIREC
Auderghem, 1160, Belgium
Imeldaziekenhuis
Bonheiden, 2820, Belgium
AZ KLINA
Brasschaat, 2930, Belgium
AZ Sint Jan
Bruges, 8000, Belgium
Institut Jules Bordet X
Brussels, 1000, Belgium
Hospital Erasme
Brussels, 1070, Belgium
Cliniques Universitaires St-Luc
Brussels, 1200, Belgium
Grand Hôpital de Charleroi Notre Dame
Charleroi, 6000, Belgium
AZ Maria Middelares
Ghent, 9000, Belgium
Jessa Zkh (Campus Salvator)
Hasselt, 3500, Belgium
UZ Leuven Gasthuisberg
Leuven, 3000, Belgium
CHC MontLégia
Liège, 4000, Belgium
CHU Sart-Tilman
Liège, 4000, Belgium
AZ St Maarten Campus Leopoldstr
Mechelen, 2800, Belgium
Hôpital André Vésale
Montigny-le-Tilleul, 6110, Belgium
AZ Damiaan
Ostend, 8400, Belgium
AZ Delta (Campus Wilgenstraat)
Roeselare, 8800, Belgium
AZ Glorieux- vzw Werken Glorieux
Ronse, 9600, Belgium
AZ Nikolaas (Sint Niklaas)
Sint-Niklaas, 9100, Belgium
AZ Turnhout Sint Elisabeth
Turnhout, 2300, Belgium
CHR de Verviers - East Belgium
Verviers, 4800, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2016
First Posted
February 4, 2016
Study Start
March 14, 2016
Primary Completion
February 4, 2020
Study Completion
February 4, 2020
Last Updated
March 25, 2020
Record last verified: 2020-03