Inclusion of Elderly Patients With Colorectal Cancer in Clinical Trials (SAGE)
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.
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.
- 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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Elderly Patients With Colorectal Cancer in Clinical Trials: Factors Associated With Non Inclusion|
- Inclusion in at least one Clinical trial (amendment n°3 -02/2014) [ Time Frame: At the end of recruiting period (nov. 2012 - nov. 2016) ]
- Eligibility to participate in in at least one Clinical trial (amendment n°3 -02/2014) [ Time Frame: Four years ]
- Invitation to participate in in at least one Clinical trial (amendment n°3 -02/2014) [ Time Frame: Four years ]
|Actual Study Start Date:||November 2012|
|Study Completion Date:||November 2016|
|Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
patients aged 65 years old or older : no intervention
|Other: No intervention|
patients aged 18-64 years (added by amendment n°3 -02/2014) : no intervention
|Other: No intervention|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01754636
|Henri Mondor Hospital|
|Creteil, Val de Marne, France, 94010|