Randomized study evaluating the impact of an innovative and cooperative pathway integrating oncogeriatric, pharmaceutical and pharmacological follow-up in elderly patients (>70 years old) presenting with cancer and treated with oral therapy_POG

Authors
Category Primary study
Registry of TrialsClinical Trials Information System
Year 2026
INTERVENTION: Product Name: ABEMACICLIB, Product Code:SUB171907, Pharmaceutical Form: FILM‐COATED TABLET, Other descriptive name: , Strength: , Product Name: PAZOPANIB, Product Code:SUB29175, Pharmaceutical Form: FILM COATED TABLETS, Other descriptive name: , Strength: , Product Name: CAPECITABINE, Product Code:SUB12474MIG, Pharmaceutical Form: FILM COATED TABLET, Other descriptive name: , Strength: , Product Name: AXITINIB, Product Code:SUB25427, Pharmaceutical Form: FILM‐COATED TABLET, Other descriptive name: , Strength: , Product Name: OLAPARIB, Product Code:SUB32234, Pharmaceutical Form: FILM‐COATED TABLET, Other descriptive name: , Strength: , Product Name: TIPIRACIL, Product Code:SUB174128, Pharmaceutical Form: FILM COATED TABLET, Other descriptive name: , Strength: , Product Name: TRIFLURIDINE, Product Code:SUB11291MIG, Pharmaceutical Form: FILM‐COATED TABLET, Other descriptive name: , Strength: , Product Name: OSIMERTINIB, Product Code:SUB176340, Pharmaceutical Form: FILM‐COATED TABLET, Other descriptive name: , Strength: , Product Name: ENZALUTAMIDE, Product Code:SUB77412, Pharmaceutical Form: CAPSULE, SOFT, Other descriptive name: , Strength: , Product Name: PALBOCICLIB, Product Code:SUB177204, Pharmaceutical Form: CAPSULE, HARD, Other descriptive name: , Strength: , Product Name: RIBOCICLIB, Product Code:SUB180246, Pharmaceutical Form: FILM‐COATED TABLET, Other descriptive name: , Strength: , Product Name: LENVATINIB, Product Code:SUB64419, Pharmaceutical Form: CAPSULE, HARD, Other descriptive name: , Strength: , Product Name: BRIGATINIB, Product Code:SUB184911, Pharmaceutical Form: FILM‐COATED TABLET, Other descriptive name: , Strength: , Product Name: EVEROLIMUS, Product Code:SUB02065MIG, Pharmaceutical Form: TABLET, Other descriptive name: , Strength: , Product Name: CABOZANTINIB, Product Code:SUB93452, Pharmaceutical Form: FILM‐COATED TABLET, Other descriptive name: , Strength: , Product Name: SUNITINIB, Product Code:SUB22321, Pharmaceutical Form: CAPSULE, HARD, Other descriptive name: , Strength: , Product Name: ALECTINIB HYDROCHLORIDE, Product Code:SUB177048, Pharmaceutical Form: CAPSULE, HARD, Other descriptive name: , Strength: , Product Name: ABIRATERONE ACETATE, Product Code:SUB31647, Pharmaceutical Form: FILM‐COATED TABLET, Other descriptive name: , Strength: , Product Name: REGORAFENIB, Product Code:SUB73090, Pharmaceutical Form: FILM‐COATED TABLET, Other descriptive name: , Strength: CONDITION: Elderly patients (>70 years old) presenting with cancer and treated with oral therapy in cohorts: • Breast cohort: Abemaciclib, Ribociclib, Palbociclib, Everolimus • Lung cohort: Alectinib, Brigatinib, Osimertinib • Prostate cohort: Abiraterone, Enzalutamide, Olaparib • Colon Cohort: Trifluridine+Tipiracil, Capecitabine • Kidney cohort: Axitinib, Cabozantinib, Lenvatinib • Sarcoma/ GIST cohort: Sunitinib, Regorafenib, Pazopanib Therapeutic area: Diseases [C] ‐ Immune System Diseases [C20] PRIMARY OUTCOME: Main Objective: To assess the impact of reinforced multi‐professional care pathway (oncologist, geriatrician, pharmacist, pharmacologist) in geriatric oncology on the occurrence of grade =3 non‐hematologic adverse event or grade =4 hematologic adverse event (according to (NCI‐CTCAE Version 6.0) over a maximum of 24 months in patients aged of at least 70 years and starting an oral anticancer treatment compared to usual care. Primary end point(s): Rate of subjects who had at least one grade =3 non‐hematologic or grade =4 hematologic adverse event assessed during oncologist consultations according to the National Cancer Institute Common Toxicity Scale Criteria for Adverse Events Version 6.0 (NCI‐CTCAE Version 6.0) on the duration of treatment with oral anticancer drug started at inclusion. The adverse events will be collected at M1, M3 then every 3 months. Secondary Objective: To evaluate the impact of the implementation of reinforced and multi‐professional care pathway (oncologist, geriatrician, pharmacist, pharmacologist) in geriatric oncology on: •Number of adverse events that appeared over 24 months (NCI‐CTCAE Version 6.0) •Overall survival, progression‐free survival, and time to discontinuation over 24 months •Quality of life questionnaires (EORTC QLQ‐C30 and EuroQol EQ5D‐5L questionnaires) at baseline (M0), M1, M3, M6, M12 and M24 •Numbers of hospitalizations, unscheduled hospitalizations, emergency room visits, care provided in hospitals (geriatric consultations, pharmaceutical interviews (hospital pharmacist), pharmacological dosing) and care provided in the community (consultations with general practitioners, specific pharmaceutical interviews for patients taking oral anticancer drugs (community pharmacist)) over 24 months •Medication compliance score measured at baseline (M0) and then every 3 months (Girerd questionnaire), To evaluate patients included in the interventional arm: •Pharmacokinetic parameters (plasma concentrations, number of off‐target patients, etc.) for dosed oral anticancer drugs and changes in anticancer treatment related to the pharmacological dosage at M1, M3 and M6 (or anticipated if progression, toxicity, or hospitalization) after the first administration of treatment •Evolution of weight, BMI and autonomy (ADL and IADL) every 3 months, the different items of the Geriatric Core DatasET (G‐CODE) at baseline (M0), M6, M12 and M24, and the different domains of intrinsic capacity (ICOPE) at baseline (M0), M3 and at the end of the study •Number and rate of acceptance of pharmaceutical interventions, the proportion of potentially inappropriate drug prescriptions, the number of drugs, the complexity of the prescription, the number of patients having benefited from a pharmaceutical interview at the pharmacy for patients under oral anticancer treatments, To evaluate caregivers (optional): Primary caregiver burden at baseline (M0), M6, M12 and M24 (Zarit questionnaire), To conduct an economic evaluation of the study intervention (cost‐effectiveness analysis) from the healthcare system perspective, and with the duration of the study as a time horizon., To assess patient satisfaction at M6, M12 and M24; and, optionally, healthcare professional satisfaction at the end of the study. SECONDARY OUTCOME: Secondary end point(s):For all patients : •Number of adverse events •Averall survival • Progression‐free survival •Time to discontinuation of oral anticancer treatment • Rate of subjects having had at least one hospitalization in the 24 months following inclusion.• The incremental net monetary benefit (INMB) and incremental cost‐effectiveness ratio (ICER) (cost‐effectiveness analysis).• Quality of life questionnaires (EORTC QLQ‐C30 and EuroQol EQ5D‐5L questionnaires) at baseline (M0), M1, M3, M6, M12 and M24 Secondary end point(s):For patients in the interventional arm: • The average number of pharmaceutical interventions performed for the oncologist and the general practitioner • The proportion of patients with at least one potentially inappropriate drug prescription before and 3 months after pharmaceutical maintenance• The average number of medications prescribed per patient before and after the pharmaceutical interview • The complexity of the drug prescription assessed according to the MRCI score before and after INCLUSION CRITERIA: Age = 70 years old, Patients must be affiliated to a social security system or beneficiary of the same, G8 score =14, PS = 3, Follow‐up for a locally advanced or metastatic solid tumor among the following: • Breast Cohort • Lung Cohort • Prostate cohort • Colon Cohort • Kidney Cohort • Sarcoma/GIST cohort, With a decision to initiate treatment with oral therapy (Tyrosine Kinase Inhibitor, Hormone Therapy) from among the following: • Breast cohort: Abemaciclib, Ribociclib, Palbociclib, Everolimus • Lung cohort: Alectinib, Brigatinib, Osimertinib • Prostate cohort: Abiraterone, Enzalutamide, Olaparib • Colon cohort: Trifluridine + Tipiracil, Capecitabine • Kidney cohort: Axitinib, Cabozantinib, Lenvatinib • Sarcoma/ GIST cohort: Sunitinib, Regorafenib, Pazopanib, Female patients must either be of non‐reproductive potential or must have a negative serum pregnancy test within 14 days prior to the administration of study drug. Childbearing potential women must have agree
Epistemonikos ID: 4a49f6aca66c6d4754180e65c2b517bac5209001
First added on: Oct 08, 2026