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

December 30, 2025 updated by: Centre Paul Strauss

Monocentric Randomized Study Evaluating the Impact of an Early Multidisciplinary Program in Elderly Subjects Starting a Chemotherapy for Digestive Cancer: Multidisciplinary Evaluation of Elderly Patients With Digestive Cancer (EPODIG-G)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Strasbourg, France, 67033
        • Recruiting
        • Institut de cancérologie Strasbourg Europe
        • Principal Investigator:
          • Meher BEN ABDELGHANI, MD
        • Sub-Investigator:
          • Damien HEITZ, MD
        • Sub-Investigator:
          • Virginie LEROY, MD
        • Contact:
        • Sub-Investigator:
          • Pascale CHIAPPA, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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 for a treatment period of 24 weeks or more
  • 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)
  • Cancer currently being treated (except for hormone therapy) other than current digestive cancer
  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Arm A Standard of care

Patients will receive standard care before treatment initiation (i.e. geriatric assessment only).

Geriatric assessment includes: Mini Mental State Examination ; mini-Geriatric Depression Scale (mini-GDS) ; Body Mass Index (BMI) calculation ; Mini Nutritional Assessment (MNA) ; Time up and Go ; Cumulative Illness Rating Scale - Geriatric (CIRS-G) ; Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) questionnaires.
Experimental: Arm B Multidisciplinary EPODIG program
Patients will undergo the same geriatric assessment as in Arm A plus EPODIG-G program before treatment initiation.
Other: EPODIG-G program (coordination of supportive care)
EPODIG-G program includes: a nutritional evaluation (laboratory tests: albumin, pre-albumin, C reactive protein and vitamin D dosage, nutritional status, Handgrip test, Simple Evaluation of Food Intake (SEFI), spontaneous food intake evaluation) ; a medication reconciliation ; physical therapy (Six Minute Walk Test)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of EPODIG-G program on treatment.
Time Frame: 24 weeks after treatment initiation
Number of patients who benefit from all programmed treatment cycles at 24 weeks
24 weeks after treatment initiation

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Paul Strauss

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2021

Primary Completion (Estimated)

October 17, 2030

Study Completion (Estimated)

October 17, 2030

Study Registration Dates

First Submitted

September 23, 2021

First Submitted That Met QC Criteria

October 1, 2021

First Posted (Actual)

October 4, 2021

Study Record Updates

Last Update Posted (Actual)

January 5, 2026

Last Update Submitted That Met QC Criteria

December 30, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-018
  • 2021-A00956-35 (Other Identifier: [IDRCB])

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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