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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A00956-35 | Other Identifier | [IDRCB] |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A Standard of care | No Intervention | 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. | |
| Arm B Multidisciplinary EPODIG program | Experimental | Patients will undergo the same geriatric assessment as in Arm A plus EPODIG-G program before treatment initiation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPODIG-G program (coordination of supportive care) | Other | 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) |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valérie SARTORI | Contact | 368767223 | 33 | v.sartori@icans.eu |
| Manon VOEGELIN | Contact | 368767360 | 33 | promotion-rc@icans.eu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de cancérologie Strasbourg Europe | Recruiting | Strasbourg | 67033 | France |
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| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D009369 | Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D005767 | Gastrointestinal Diseases |
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| Progression free survival | 3 years after last inclusion |
| Overall survival | 3 years after last inclusion |