Multidisciplinary Evaluation of Elderly Patients With Digestive Cancer (EPODIG-G)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age75+
SponsorCentre Paul Strauss
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
EPODIG-G program (coordination of supportive care)
Other interventionEPODIG-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)
Treatment groups
144 Participants
are divided into 2 treatment groupsGroup A: Arm A Standard of careNo intervention 0 interventions
Group B: Arm B Multidisciplinary EPODIG programExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Impact of EPODIG-G program on treatment.
Number of patients who benefit from all programmed treatment cycles at 24 weeks
Time frame
24 weeks after treatment initiationSecondary outcomes
1
Dose-intensity evaluation. Cumulative doses and theoretical doses of chemotherapy or targeted therapy.
Time frame
24 weeks after treatment initiation2
Number of adverse events and serious adverse events according to CTCAE v5.0.
Time frame
throughout treatment, at 8, 16 and 24 weeks after treatment initiation3
Progression free survival
Time frame
3 years after last inclusion4
Overall survival
Time frame
3 years after last inclusionSponsors and contacts
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Source ClinicalTrials.gov