Inclusion of Elderly Patients With Colorectal Cancer in Clinical Trials

Colorectal Cancer Clinical Trial

— SAGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01754636
• Other study ID #: NI 11006
• Status: Completed
• Phase: N/A
• First received: December 18, 2012
• Last updated: April 13, 2017
• Start date: November 2012
• Est. completion date: November 2016

Study information

• Verified date: April 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 707
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
France	Henri Mondor Hospital	Creteil	Val de Marne

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (2)

Aparicio T, Navazesh A, Boutron I, Bouarioua N, Chosidow D, Mion M, Choudat L, Sobhani I, Mentré F, Soulé 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inclusion in at least one Clinical trial (amendment n°3 -02/2014)		At the end of recruiting period (nov. 2012 - nov. 2016)
Secondary	Eligibility to participate in in at least one Clinical trial (amendment n°3 -02/2014)		Four years
Secondary	Invitation to participate in in at least one Clinical trial (amendment n°3 -02/2014)		Four years