NCT05066139

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
55mo left

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Sep 2021Oct 2030

Study Start

First participant enrolled

September 17, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 4, 2021

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2030

Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

9.1 years

First QC Date

September 23, 2021

Last Update Submit

December 30, 2025

Conditions

NeoplasmsDigestive System Disease

Keywords

Digestive cancersupportive caregastrointestinal cancer

Outcome Measures

Primary Outcomes (1)

  • Impact of EPODIG-G program on treatment.

    Number of patients who benefit from all programmed treatment cycles at 24 weeks

    24 weeks after treatment initiation

Secondary Outcomes (4)

  • 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

  • Overall survival

    3 years after last inclusion

Study Arms (2)

Arm A Standard of care

NO INTERVENTION

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.

Arm B Multidisciplinary EPODIG program

EXPERIMENTAL

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)

Interventions

EPODIG-G program (coordination of supportive care)OTHER

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)

Arm B Multidisciplinary EPODIG program

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Patients unable to submit to medical follow-up for geographical, social or psychological reasons
  • Patients placed under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de cancérologie Strasbourg Europe

Strasbourg, 67033, France

RECRUITING

MeSH Terms

Conditions

Digestive System DiseasesNeoplasmsGastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteGastrointestinal Diseases

Central Study Contacts

Valérie SARTORI

CONTACT

368767223v.sartori@icans.eu

Manon VOEGELIN

CONTACT

368767360promotion-rc@icans.eu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2021

First Posted

October 4, 2021

Study Start

September 17, 2021

Primary Completion (Estimated)

October 17, 2030

Study Completion (Estimated)

October 17, 2030

Last Updated

January 5, 2026

Record last verified: 2025-12

Locations

FR(1)