A Multicenter Non-Interventional Study Exploring the Impact of Sarcopenia on the Outcomes of Colorectal Cancer Patients Treated With a Chemotherapy Combined With Bevacizumab

Hoffmann-La Roche23 sites in 1 country200 target enrollmentMarch 14, 2016

ConditionsMetastatic Colorectal Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Metastatic Colorectal Cancer
Sponsor: Hoffmann-La Roche
Enrollment: 200
Locations: 23
Primary Endpoint: 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
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 14, 2016

End Date

February 4, 2020

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

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 PD
•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

Outcomes

Primary Outcomes

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

Time Frame: 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

Time Frame: Up to 3 years

Secondary Outcomes

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)