Metastatic Colorectal CancerCOBEQOLNCT02842294
Cohort Study to Assess Impact of Chemotherapy Plus Bevacizumab on Health Related Quality of Life in First Line Metastatic Colorectal Cancer
An observational study of Metastatic Colorectal Cancer and Quality of Life, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer, Quality of Life
- What is being tested?
- Bevacizumab
- How many people
- 320 participants
- Where
- 1 siteFrance
- Study dates
- May 2013to Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: metastatic colorectal cancer
Who may be able to join
- age> 18years
- metastatic colorectal cancer (non resectable)
- 1st chemotherapy including bevacizuman
Who cannot join
- treatment contre-indication
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU Besançon
Besançon, Franche Comté, 25030
ikram es saad, msc, 0370632181 ext. 0033, iessaad@chu-besancon.fr
About this study
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
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.
- Conditions
- Metastatic Colorectal Cancer, Quality of Life
- Being tested
- Bevacizumab
- Keywords
- bevacizumab, health related quality of life
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
| Study group | Role | What they receive |
|---|---|---|
| irinotecan based chemotherapy | patients having a 1st line doublet chemotherapy including irinotecan Receives: Drug: Bevacizumab | |
| oxaliplatin based chemotherapy | patients having a 1st line doublet chemotherapy including oxaliplatin Receives: 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 Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (6)
time to health related quality of life score deterioration (non targeted dimensions of EORTC QLQC30 and CR 29)
Measured: 1 year
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
Measured: 1 year
quality-adjusted life years (QALYs) using EQ5D
Measured: 1 year
Overall survival
Measured: 2 years
Progression Free Survival
Measured: 1 year
treatment preference
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startMay 2013
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Franck Bonnetain, PhD, Study director, University Hospital of Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842294
- Sponsor's protocol ID
- P/2012/151
- Acronym
- COBEQOL
- Status last verified
- Jul 2016
- First submitted
- 20 Jul 2016
- Last updated
- 22 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02842294
- Acronym / sponsor ID
- COBEQOL / P/2012/151
- Conditions
- Metastatic Colorectal Cancer, Quality of Life
- Keywords
- bevacizumab, health related quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 22 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| irinotecan based chemotherapy | – | Drug: Bevacizumabpatients having a 1st line doublet chemotherapy including irinotecan |
| oxaliplatin based chemotherapy | – | Drug: Bevacizumabpatients having a 1st line doublet chemotherapy including oxaliplatin |
| triplet chemotherapy | – | Drug: Bevacizumabpatient having a 1st line triplet chemotherapy including oxaliplatin / irinotecan this cohort was added while primary objective was to compare doublet chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- metastatic colorectal cancer
Key inclusion criteria (3 listed)
- age> 18years
- metastatic colorectal cancer (non resectable)
- 1st chemotherapy including bevacizuman
Key exclusion criteria (1 listed)
- treatment contre-indication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bevacizumab | Drug | irinotecan based chemotherapy, oxaliplatin based chemotherapy, triplet chemotherapy |
Primary outcome
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.
6 secondary outcomes
time to health related quality of life score deterioration (non targeted dimensions of EORTC QLQC30 and CR 29)
Time frame: 1 year
INT PATSAT32
Time frame: 1 year
quality-adjusted life years (QALYs) using EQ5D
Time frame: 1 year
Overall survival
Time frame: 2 years
Progression Free Survival
Time frame: 1 year
treatment preference
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2016.
- Related InfoLink provided by the sponsor.
Related trials for Metastatic Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Metastatic Colorectal Cancer
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Not yet recruitingPhase 1/2
A Phase Ib/II Study of GFH276 in Combination With Chemotherapy (± Bevacizumab) or Cetuximab in Patients With RAS-mutant Metastatic Colorectal Cancer
CRC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franck Bonnetain, PhD study director
University Hospital of Besancon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer and Quality of Life, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marion Jacquin, Msc (0033370632171, fbonnetain@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to health related quality of life score deterioration (targeted dimensions of EORTC QLQC30 : global health, fatigue, emotional functioning) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2016.