Clinical trial · Observational
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
NCT02673710CI-TRIAL-00044243completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Participants with metastatic colorectal cancer
- description
- 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
- interventionNames
- Other: No intervention
Primary outcomes (2)
- measure
- 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
- timeFrame
- Up to 3 years
- measure
- 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
- timeFrame
- Up to 3 years
Secondary outcomes (26)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.