Actively Recruiting
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)
Led by Centre Paul Strauss · Updated on 2026-01-05
144
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of an early multidisciplinary geriatric program (EPODIG-G) for elderly patients aged 75 and older who are starting chemotherapy or targeted therapy to treat digestive cancer. This study takes place at a single center, the Strasbourg Europe Cancerology Institute (ICANS), and compares standard care with the EPODIG-G program to see how it affects treatment outcomes in this population. The EPODIG-G program coordinates various supportive care services including nutritional evaluations with laboratory tests, medication reviews, and physical therapy like the Six Minute Walk Test. Participants are randomly assigned to either receive standard care, which includes a comprehensive geriatric assessment, or the same assessment plus the EPODIG-G program before starting their cancer treatment. The study observes participants over a treatment period of at least 24 weeks. During the study, patients will undergo assessments such as cognitive and depression screening, nutritional status, physical function, and daily living activities. Researchers will monitor treatment impact, chemotherapy dose intensity, adverse events, and survival outcomes up to three years after enrollment. The study tracks safety and effectiveness indicators through scheduled evaluations at 8, 16, and 24 weeks following treatment start, with long-term follow-up continuing for several years.
CONDITIONS
Brief Title
Multidisciplinary Evaluation of Elderly Patients With Digestive Cancer (EPODIG-G)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be 75 years or older
- Performance status 0, 1, or 2
- Diagnosed with digestive cancer at any stage with indication for chemotherapy or targeted therapy lasting 24 weeks or more
- Patients previously treated with chemotherapy for this digestive cancer are eligible
- Estimated life expectancy of 3 months or more
- Able to speak, read, and understand French
- Signed informed consent
- Must have social security coverage
You will not qualify if you...
- History of differentiated neuroendocrine tumors grade 1 or 2 of pancreas or small intestine
- Currently treated for another cancer except hormone therapy
- Major surgery or curative radiation therapy within 4 weeks before enrollment
- Unable to attend medical follow-up due to geographic, social, or psychological reasons
- Patients under legal guardianship
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Before treatment initiation
Participants randomized to the intervention group undergo an early multidisciplinary geriatric program including nutritional evaluation, medication reconciliation, and physical therapy before starting chemotherapy.
1 visit (in-person)
Duration - Approximately 24 weeks
Participants receive chemotherapy or targeted therapy for digestive cancer, lasting approximately 24 weeks. Supportive care coordination is provided according to assigned group.
Visits at 8, 16, and 24 weeks after treatment initiation
Duration - Up to 3 years after last inclusion
Participants are monitored for progression-free and overall survival up to 3 years after last inclusion.
Visit schedule depends on clinical follow-up
Trial Site Locations
Total: 1 location
1
Institut de cancérologie Strasbourg Europe
Strasbourg, France, 67033
Actively Recruiting
Research Team
V
Valérie SARTORI
M
Manon VOEGELIN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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