Digestive System Disease, Neoplasms
Conditions
Keywords
Digestive cancer, supportive care, gastrointestinal cancer
Brief summary
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
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.
Interventions
OTHEREPODIG-G program (coordination of supportive care)
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)
Sponsors
Centre Paul Strauss
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of EPODIG-G program on treatment. | 24 weeks after treatment initiation | Number of patients who benefit from all programmed treatment cycles at 24 weeks |
Secondary
| Measure | 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 |
Countries
France
Contacts
Primary ContactValérie SARTORI
Backup ContactManon VOEGELIN
Outcome results
None listed