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
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 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 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 Participants body weight at initial diagnosis of mCRC Up to 3 years Dietary and physical counselling Up 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
Scroll for more (13 remaining)Onze Lieve Vrouwziekenhuis Aalst🇧🇪Aalst, Belgium