Inclusion of Elderly Patients With Colorectal Cancer in Clinical Trials

Colorectal Cancer

Colorectal neoplasms, Elderly, Randomized clinical trials, 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: 1. eligible at least to one RCT 2. invited to participate 3. 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.

France