Multidisciplinary Evaluation of Elderly Patients With Digestive Cancer (EPODIG-G)

Not Applicable

Recruiting

• Conditions: Digestive System Disease; Neoplasms
• Interventions: Other: EPODIG-G program (coordination of supportive care)

• Registration Number: NCT05066139
• Lead Sponsor: Institut de cancérologie Strasbourg Europe

Brief Summary

This is a monocentric, comparative, open-label, randomized parallel group study enrolling elderly subjects hospitalized in Strasbourg Europe Cancerology Institute (ICANS), starting chemotherapy or targeted therapy for the treatment of digestive cancer.

Detailed Description

At the ICANS an EPODIG-G program, consisting in a coordination of supportive care that are existing in the Institute, is proposed to elderly patients with digestive cancer. The purpose of this study is to evaluate the impact of this early multidisciplinary geriatric program (EPODIG-G), when it is initiated before therapeutic treatment.

Study Timeline

• Study Start: 2021-09-17
• Study First Submitted: 2021-09-23
• Study First Submitted QC: 2021-10-01
• Study First Posted: 2021-10-04
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-23
• Last Update Posted: 2022-11-25
• Primary Completion: 2024-03-17
• Study Completion: 2026-09-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

• Patients must be ≥ 75 years old
• Performance status 0, 1 or 2
• Diagnostic of digestive cancer, all stages (adjuvant or metastatic), with an indication for chemotherapy treatment or targeted therapy
• Patients previously treated with one or several lines of chemotherapy for this digestive cancer are eligible
• Estimated life expectancy ≥ 3 months
• Patients able to speak, read and understand French
• Signed informed consent from the patient
• Patients must have a social security coverage

Exclusion Criteria

• History of differentiated neuroendocrine tumors grade 1 or 2 (pancreas, small intestine)
• History of another treated cancer during the last five years
• History of major surgery and/or curative radiation therapy during the last 4 weeks before inclusion
• Patients unable to submit to medical follow-up for geographical, social or psychological reasons
• Patients placed under guardianship

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B Multidisciplinary EPODIG program	EPODIG-G program (coordination of supportive care)	Patients will undergo the same geriatric assessment as in Arm A plus EPODIG-G program before treatment initiation.

Primary Outcome Measures

Name	Time	Method
Impact of EPODIG-G program on treatment.	24 weeks after treatment initiation	Number of patients who benefit from all programmed treatment cycles at 24 weeks

Secondary Outcome Measures

Name	Time	Method
Overall survival	3 years after last inclusion
Dose-intensity evaluation. Cumulative doses and theoretical doses of chemotherapy or targeted therapy.	24 weeks after treatment initiation
Number of adverse events and serious adverse events according to CTCAE v5.0.	throughout treatment, at 8, 16 and 24 weeks after treatment initiation
Progression free survival	3 years after last inclusion

Trial Locations

Locations (1)

Institut de cancérologie Strasbourg Europe; 🇫🇷 Strasbourg, France