Cohort Study to Assess Impact of Chemotherapy Plus Bevacizumab on Health Related Quality of Life in First Line Metastatic Colorectal Cancer
COBEQOL
Etude de Cohorte évaluant l'Impact de l'Association chimiothérapie et Bevacizumab en 1ère Ligne du Cancer Colorectal métastatique Sur la qualité de Vie Relative Des Patients. Etude COBEQOL
1 other identifier
observational
320
1 country
1
Brief Summary
The primary aim of this french multicenter national study is to assess and compare time to quality of life score deterioration (targeted dimensions : global health, fatigue and emotional functionning of EORTC QLQC30 according to the first line chemotherapy associated with bevacizumab in metastatic colorectal patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2013
Longer than P75 for all trials
1 active site
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
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 20, 2016
CompletedFirst Posted
Study publicly available on registry
July 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedJuly 22, 2016
July 1, 2016
3.8 years
July 20, 2016
July 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
time to health related quality of life score deterioration (targeted dimensions of EORTC QLQC30 : global health, fatigue, emotional functioning)
The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients.
1 year
Secondary Outcomes (6)
time to health related quality of life score deterioration (non targeted dimensions of EORTC QLQC30 and CR 29)
1 year
INT PATSAT32
1 year
quality-adjusted life years (QALYs) using EQ5D
1 year
Overall survival
2 years
Progression Free Survival
1 year
- +1 more secondary outcomes
Study Arms (3)
irinotecan based chemotherapy
patients having a 1st line doublet chemotherapy including irinotecan
oxaliplatin based chemotherapy
patients having a 1st line doublet chemotherapy including oxaliplatin
triplet chemotherapy
patient having a 1st line triplet chemotherapy including oxaliplatin / irinotecan this cohort was added while primary objective was to compare doublet chemotherapy
Interventions
Eligibility Criteria
metastatic colorectal cancer
You may qualify if:
- age\> 18years
- metastatic colorectal cancer (non resectable)
- st chemotherapy including bevacizuman
You may not qualify if:
- treatment contre-indication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHRU Besançon
Besançon, Franche Comté, 25030, France
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Franck Bonnetain, PhD
University Hospital of Besancon
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2016
First Posted
July 22, 2016
Study Start
May 1, 2013
Primary Completion
February 1, 2017
Study Completion
February 1, 2018
Last Updated
July 22, 2016
Record last verified: 2016-07