Clinical trial · Interventional
Multidisciplinary Evaluation of Elderly Patients With Digestive Cancer (EPODIG-G)
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)
NCT05066139CI-TRIAL-00100081EPODIG-GrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Digestive System Disease | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EPODIG-G program (coordination of supportive care) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Arm A Standard of care
- description
- 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.
- type
- EXPERIMENTAL
- label
- Arm B Multidisciplinary EPODIG program
- description
- Patients will undergo the same geriatric assessment as in Arm A plus EPODIG-G program before treatment initiation.
- interventionNames
- Other: EPODIG-G program (coordination of supportive care)
Primary outcomes (1)
- measure
- Impact of EPODIG-G program on treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.