- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01754636
Inclusion of Elderly Patients With Colorectal Cancer in Clinical Trials (SAGE)
Elderly Patients With Colorectal Cancer in Clinical Trials: Factors Associated With Non Inclusion
Background: Inadequate representation of elderly cancer patients in randomized clinical trials (RCTs) leading to a lack of external validity thereby an uncertainty regarding benefit-risk balance of cancer treatment in elderly, especially chemotherapy.
Hypothesis: The eligibility criteria explain only a part of the under-representation of elderly patients in trials. We make the assumptions that 1) Among the eligible, the invitation to participate in a trial and inclusion are inversely related to age, 2) Among the eligible, there are patients, practitioner, or organization factors that would explain the non inclusion of elderly patients.
Objectives:
1) To assess, in elderly patients with colorectal cancer, the proportions of patients:
- eligible at least to one RCT
- invited to participate
- included 2)
a) Compare proportions among elderly patients to those of the comparator group of "young" subjects (age ≥ 18 and <65 years) (added by amendment n°3 accepted 18/02/2014) b)To identify factors associated with the non-invitation and the non-inclusion in RCT.
Material and methods:
Study design: A multicentric prospective cohort survey Population: all patients aged 18 years or more (added by amendment n°3 - 02/2014) with a colorectal cancer followed in one of the participating centers.
Data collection:
- At baseline: Patient characteristics (including SOCIO-demographic, oncologic and geriatric data) will be collected. Organization factors (e.g. clinical research team) will be collected.
- Follow-up: the patient will be followed for potential invitation and inclusion in one RCT. Reasons of non-invitation or non-inclusion will be assessed.
Number of subjects needed: 696 (553 elderly patients and 143 "young" patients) Number of centers : 7 (added by amendment n°3 - 02/2014)
Ethical aspects: each patient will give his oral informed consent. The International Review Board of Mondor Hospital (CPP Ile-de-France IX) gave its approval in December 2012.
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Val de Marne
-
Creteil, Val de Marne, France, 94010
- Henri Mondor Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Patient aged of of 18 years and older (modified by amendment n°3 - 02/2014)
For a diagnosed colorectal cancer (CRC) irrespective of the stage
Exclusion Criteria:
None
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Elderly patients
patients aged 65 years old or older : no intervention
|
|
"Young" patients
patients aged 18-64 years (added by amendment n°3 -02/2014) : no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Inclusion in at least one Clinical trial (amendment n°3 -02/2014)
Time Frame: At the end of recruiting period (nov. 2012 - nov. 2016)
|
At the end of recruiting period (nov. 2012 - nov. 2016)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Eligibility to participate in in at least one Clinical trial (amendment n°3 -02/2014)
Time Frame: Four years
|
Four years
|
Invitation to participate in in at least one Clinical trial (amendment n°3 -02/2014)
Time Frame: Four years
|
Four years
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Aparicio T, Navazesh A, Boutron I, Bouarioua N, Chosidow D, Mion M, Choudat L, Sobhani I, Mentre F, Soule JC. Half of elderly patients routinely treated for colorectal cancer receive a sub-standard treatment. Crit Rev Oncol Hematol. 2009 Sep;71(3):249-57. doi: 10.1016/j.critrevonc.2008.11.006. Epub 2009 Jan 7.
- Lewis JH, Kilgore ML, Goldman DP, Trimble EL, Kaplan R, Montello MJ, Housman MG, Escarce JJ. Participation of patients 65 years of age or older in cancer clinical trials. J Clin Oncol. 2003 Apr 1;21(7):1383-9. doi: 10.1200/JCO.2003.08.010.
- Canoui-Poitrine F, Lievre A, Dayde F, Lopez-Trabada-Ataz D, Baumgaertner I, Dubreuil O, Brunetti F, Coriat R, Maley K, Pernot S, Tournigand C, Hagege M, Aparicio T, Paillaud E, Bastuji-Garin S. Inclusion of Older Patients with Cancer in Clinical Trials: The SAGE Prospective Multicenter Cohort Survey. Oncologist. 2019 Dec;24(12):e1351-e1359. doi: 10.1634/theoncologist.2019-0166. Epub 2019 Jul 19.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NI 11006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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