Metastatic Colorectal Cancer
Conditions
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.
Interventions
OTHERNo intervention
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
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| Functional status using Functional Assessment for Cancer Treatment - specific for Colorectal cancer participants | Up to 3 years |
| Participants C-Reactive Protein and Albumin blood values at Initial Diagnosis | 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 |
| Participants mutation status at Initial Diagnosis | Up to 3 years |
| Participant Physical status expressed in muscle strength | Up to 3 years |
Countries
Belgium
Outcome results
None listed