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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02842294
Recruitment Status : Unknown
Verified July 2016 by Centre Hospitalier Universitaire de Besancon.
Recruitment status was:  Recruiting
First Posted : July 22, 2016
Last Update Posted : July 22, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Metastatic Colorectal Cancer Quality of Life Drug: Bevacizumab

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Study Type : Observational
Estimated Enrollment : 320 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : May 2013
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Group/Cohort Intervention/treatment
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



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


Secondary Outcome Measures :
  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 [ Time Frame: 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

  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
metastatic colorectal cancer
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • treatment contre-indication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842294


Contacts
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Contact: Marion Jacquin, Msc 0033370632171 fbonnetain@chu-besancon.fr
Contact: Ikram El SaaD, Msc 0033370632181 iessaad@chu-besancon.fr

Locations
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France
CHRU Besançon Recruiting
Besançon, Franche Comté, France, 25030
Contact: ikram es saad, msc    0370632181 ext 0033    iessaad@chu-besancon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Study Director: Franck Bonnetain, PhD University Hospital of Besancon
Additional Information:
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02842294    
Other Study ID Numbers: P/2012/151
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: July 22, 2016
Last Verified: July 2016
Keywords provided by Centre Hospitalier Universitaire de Besancon:
bevacizumab
health related quality of life
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors