Cohort Study to Assess Impact of Chemotherapy Plus Bevacizumab on Health Related Quality of Life in First Line Metastatic Colorectal Cancer

• Conditions: Metastatic Colorectal Cancer; Quality of Life
• Interventions: Drug: Bevacizumab

• Registration Number: NCT02842294
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-05
• Status Verified: 2016-07
• Study First Submitted: 2016-07-20
• Study First Submitted QC: 2016-07-21
• Last Update Submitted: 2016-07-21
• Study First Posted: 2016-07-22
• Last Update Posted: 2016-07-22
• Primary Completion: 2017-02
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

• age> 18years
• metastatic colorectal cancer (non resectable)
• 1st chemotherapy including bevacizuman

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Exclusion Criteria

• treatment contre-indication

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
irinotecan based chemotherapy	Bevacizumab	patients having a 1st line doublet chemotherapy including irinotecan
oxaliplatin based chemotherapy	Bevacizumab	patients having a 1st line doublet chemotherapy including oxaliplatin
triplet chemotherapy	Bevacizumab	patient having a 1st line triplet chemotherapy including oxaliplatin / irinotecan this cohort was added while primary objective was to compare doublet chemotherapy

Primary Outcome Measures

Name	Time	Method
time to health related quality of life score deterioration (targeted dimensions of EORTC QLQC30 : global health, fatigue, emotional functioning)	1 year	The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients.

Secondary Outcome Measures

Name	Time	Method
Overall survival	2 years
Progression Free Survival	1 year
treatment preference	1 year
INT PATSAT32	1 year	The EORTC IN-PATSAT32 is a 32-item satisfaction with care questionnaire to measure patients' appraisal of hospital doctors and nurses, as well as aspects of care organisation and services. It addresses technical competence, information provision, interpersonal skills, availability, waiting time, access, comfort and overall care perception
time to health related quality of life score deterioration (non targeted dimensions of EORTC QLQC30 and CR 29)	1 year
quality-adjusted life years (QALYs) using EQ5D	1 year

Trial Locations

Locations (1)

CHRU Besançon; 🇫🇷 Besançon, Franche Comté, France