Inclusion of Elderly Patients With Colorectal Cancer in Clinical Trials

Completed

• Conditions: Colorectal Cancer
• Interventions: Other: No intervention

• Registration Number: NCT01754636
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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:

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-12-18
• Study First Submitted QC: 2012-12-18
• Study First Posted: 2012-12-21
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-13
• Last Update Posted: 2017-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 707

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
"Young" patients	No intervention	patients aged 18-64 years (added by amendment n°3 -02/2014) : no intervention
Elderly patients	No intervention	patients aged 65 years old or older : no intervention

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Henri Mondor Hospital; 🇫🇷 Creteil, Val de Marne, France