Inclusion of Elderly Patients With Colorectal Cancer in Clinical Trials

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Elderly Patients With Colorectal Cancer in Clinical Trials: Factors Associated With Non Inclusion

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Elderly patients<br>patients aged 65 years old or older : no intervention | Other: No intervention<br> <br> |
| Young patients<br>patients aged 18-64 years (added by amendment n°3 -02/2014) : no intervention | Other: No intervention<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inclusion in at least one Clinical trial (amendment n°3 -02/2014) |  | At the end of recruiting period (nov. 2012 - nov. 2016) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eligibility to participate in in at least one Clinical trial (amendment n°3 -02/2014) |  | Four years | 
| Invitation to participate in in at least one Clinical trial (amendment n°3 -02/2014) |  | Four years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elderly, Colorectal neoplasms, Randomized clinical trials, Inclusion.