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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Digestive System Disease, Neoplasms

Intervention / Treatment
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* Other: EPODIG-G program (coordination of supportive care)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Arm A Standard of care<br>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. | |
| Experimental: Arm B Multidisciplinary EPODIG program<br>Patients will undergo the same geriatric assessment as in Arm A plus EPODIG-G program before treatment initiation. | Other: EPODIG-G program (coordination of supportive care)<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digestive cancer, supportive care, gastrointestinal cancer