Inclusion of Elderly Patients With Colorectal Cancer in Clinical Trials

NCT01754636 | Completed

• 1 other identifier: NI 11006
• Study Type: observational
• Target: 707
• Locations: 1 country
• Sites: 1

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:

• 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.

Conditions

Colorectal Cancer

Keywords

Colorectal neoplasms; Elderly; Randomized clinical trials; Inclusion.

Outcome Measures

Primary Outcomes (1)

• Inclusion in at least one Clinical trial (amendment n°3 -02/2014)

  At the end of recruiting period (nov. 2012 - nov. 2016)

Secondary Outcomes (2)

• 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

Study Arms (2)

Elderly patients

patients aged 65 years old or older : no intervention

Other: No intervention

"Young" patients

patients aged 18-64 years (added by amendment n°3 -02/2014) : no intervention

Other: No intervention

Interventions

No intervention OTHER

"Young" patients; Elderly patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population: all patients aged 18 years or more with a colorectal cancer followed in one of the participating centers (amendment n°3 - 02/2014)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Henri Mondor Hospital

Créteil, Val de Marne, 94010, France

Location

Related Publications (3)

• Aparicio T, Navazesh A, Boutron I, Bouarioua N, Chosidow D, Mion M, Choudat L, Sobhani I, Mentre F, Soule 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.

  PMID: 19131256 BACKGROUND

• 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. doi: 10.1200/JCO.2003.08.010.

  PMID: 12663731 BACKGROUND

• Canoui-Poitrine F, Lievre A, Dayde F, Lopez-Trabada-Ataz D, Baumgaertner I, Dubreuil O, Brunetti F, Coriat R, Maley K, Pernot S, Tournigand C, Hagege M, Aparicio T, Paillaud E, Bastuji-Garin S. Inclusion of Older Patients with Cancer in Clinical Trials: The SAGE Prospective Multicenter Cohort Survey. Oncologist. 2019 Dec;24(12):e1351-e1359. doi: 10.1634/theoncologist.2019-0166. Epub 2019 Jul 19.

  PMID: 31324663 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2012
• First Posted: December 21, 2012
• Study Start: November 1, 2012
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: April 14, 2017

Record last verified: 2017-04

Locations

FR (1)