Evaluation of a supportive care program for elderly patients with digestive cancer
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 study is testing whether a new supportive care program can help elderly patients with digestive cancer feel better during their chemotherapy or targeted therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 75 Years and up |
| Sex | All |
| Sponsor | Centre Paul Strauss Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT05066139 on ClinicalTrials.gov |
What this trial studies
This study involves elderly patients aged 75 and older who are hospitalized at the Strasbourg Europe Cancerology Institute and are starting chemotherapy or targeted therapy for digestive cancer. It aims to assess the impact of an early multidisciplinary supportive care program, known as EPODIG-G, which coordinates existing supportive care services at the institute. The study is designed as a monocentric, comparative, open-label, randomized parallel group trial to evaluate the benefits of this program when initiated prior to therapeutic treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly patients aged 75 and older diagnosed with any stage of digestive cancer who are about to begin chemotherapy or targeted therapy.
Not a fit: Patients with a history of differentiated neuroendocrine tumors or those unable to comply with medical follow-up may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could enhance the quality of care and improve treatment outcomes for elderly patients with digestive cancer.
How similar studies have performed: While similar supportive care programs have shown promise in improving outcomes for cancer patients, this specific approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Strasbourg
- Institut de cancérologie Strasbourg Europe — Strasbourg, France (Recruiting)
Study contacts
- Study coordinator: Valérie SARTORI
- Email: v.sartori@icans.eu
- Phone: 368767223
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.