CClinicalTrials.gg
Status unknownNCT02842294COBEQOLUpdated Jul 22, 2016

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

An observational study in Metastatic Colorectal Cancer and Quality of Life, sponsored by Centre Hospitalier Universitaire de Besancon. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-22.

Sponsored by Centre Hospitalier Universitaire de Besancon · Observational

The sponsor has not verified this record recently (last verified Jul 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
320
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Metastatic Colorectal Cancer
  • Quality of Life

Keywords

  • bevacizumab
  • health related quality of life
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In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 320 is above the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Centre Hospitalier Universitaire de Besancon is the lead sponsor of 439 studies on the registry; 97 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

metastatic colorectal cancer

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • treatment contre-indication
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
320 participants (estimated)
Patient registry
No

Groups and cohorts

  • irinotecan based chemotherapy

    patients having a 1st line doublet chemotherapy including irinotecan

    Drug: Bevacizumab

  • oxaliplatin based chemotherapy

    patients having a 1st line doublet chemotherapy including oxaliplatin

    Drug: Bevacizumab

  • triplet chemotherapy

    patient having a 1st line triplet chemotherapy including oxaliplatin / irinotecan this cohort was added while primary objective was to compare doublet chemotherapy

    Drug: Bevacizumab

Interventions

  • DrugBevacizumab
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What researchers measure

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.

    Time frame: 1 year

Secondary outcomes

  1. time to health related quality of life score deterioration (non targeted dimensions of EORTC QLQC30 and CR 29)

    Time frame: 1 year

  2. INT PATSAT32

    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 frame: 1 year

  3. quality-adjusted life years (QALYs) using EQ5D

    Time frame: 1 year

  4. Overall survival

    Time frame: 2 years

  5. Progression Free Survival

    Time frame: 1 year

  6. treatment preference

    Time frame: 1 year

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Study locations

1 of 1 sites recruiting
  • CHRU Besançon
    Besançon, Franche Comté 25030, France
    Recruiting
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References and documents

Related links

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02842294
Lead sponsor
Centre Hospitalier Universitaire de Besancon
Responsible party
Sponsor
First posted
Jul 22, 2016
Start date
May 2013
Primary completion
Feb 2017 (estimated)
Completion
Feb 2018 (estimated)
Last update
Jul 22, 2016

Study contacts

Marion Jacquin, Msc
Contact
fbonnetain@chu-besancon.fr
0033370632171
Ikram El SaaD, Msc
Contact
iessaad@chu-besancon.fr
0033370632181
Franck Bonnetain, PhD
study director · University Hospital of Besancon

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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