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Innovative and Cooperative Pathway Integrating Oncogeriatric, Pharmaceutical and Pharmacological Follow-up in Elderly Patients.

NCT07802847 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 794

Last updated 2026-09-03

No results posted yet for this study

Summary

The incidence of cancer among older adults is increasing as a result of longer life expectancy. Therapeutic advances have led oncologists to propose new available treatments for these patients, particularly oral therapies, whether targeted therapies or hormone therapies. However, these patients are more vulnerable and have an increased risk of treatment-related toxicity or inefficacy. Indeed, they more frequently suffer from comorbidities (renal, cardiac, hepatic insufficiency, etc.) and present risk factors (polypharmacy, cognitive disorders, etc.) known to reduce the effectiveness or increase the toxicity of oral therapies due to variations in plasma drug concentrations.

For several years, various international recommendations (ASCO, ESMO, etc.) have suggested that specialized geriatatric oncology care is indicated for these patients. Similarly, some studies have shown that pharmacist involvement may have an impact by reducing drug-drug interaction issues or non-adherence. Finally, the introduction of oral therapies in oncology has raised pharmacological challenges: regular pharmacokinetic monitoring could allow dose adjustments in cases of disease progression in undertreated patients or toxicity in overexposed patients.

Our hypothesis is that implementing an integrative care pathway in this population could demonstrate a benefit by improving quality of care, reducing toxicity, optimizing efficacy, and maintaining an acceptable cost. This approach could help prevent early treatment discontinuation due to disease progression related to insufficient drug concentrations, as well as certain toxicities related to overdosing (e.g., drug-drug interactions), leading to improved quality of life and a reduction in rehospitalization rates.

Conditions

Interventions

OTHER

Experimental

Pharm-Onco-Geriatric (POG) pathway which allows triple oncogeriatric, pharmaceutical and pharmacological follow-up. The main interventions according to the areas will be the following: Pharmacological (pharmacokinetic assays with a 5mL blood sampling (samples to be collected at trough (pre-dose), dosage adjustment in the event of underexposure or overexposure), Pharmaceutical (understanding of oral anticancer therapy, co-medications, tolerance assessment, adherence assessment) and Geriatric (oncogeriatric Follow-up, monitoring of the appearance of frailty criteria during treatment by the G-CODE tool, collection of hospitalizations data, admission in emergency rooms, incidents, modification of the living address).

Sponsors & Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2031-09-30
Completion
2031-09-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07802847 on ClinicalTrials.gov