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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05066139
Other study ID # 2020-018
Secondary ID 2021-A00956-35
Status Recruiting
Phase N/A
First received
Last updated
Start date September 17, 2021
Est. completion date September 17, 2026

Study information

Verified date November 2022
Source Institut de cancérologie Strasbourg Europe
Contact Valérie SARTORI
Phone 368767223
Email v.sartori@icans.eu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 144
Est. completion date September 17, 2026
Est. primary completion date March 17, 2024
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility 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


Intervention

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)

Locations

Country Name City State
France Institut de cancérologie Strasbourg Europe Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
Institut de cancérologie Strasbourg Europe

Country where clinical trial is conducted

France, 

Outcome

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