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

Neoplasms Clinical Trial

— EPODIG-G  

Official title:

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)

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
• 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
• 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

Related Conditions & MeSH terms

• Digestive System Disease
• Digestive System Diseases
• Gastrointestinal Diseases
• Neoplasms

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