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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age70+
SponsorGustave Roussy, Cancer Campus, Grand Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 70 years old

G8 score ≤ 14

ECOG PS ≤ 3

Follow-up for a locally advanced or metastatic solid tumor among the following: breast, lung, prostate, colon, kidney, sarcoma, GIST cohorts

Disqualifiers

Patient who has already been treated or is currently being treated with the oral therapy studied

Grade 3 or 4 toxicity contraindicating the implementation of oral treatment, according to the NCI-CTCAE version 6.0

Patient unable to follow treatment program

Mental or psychological illness that does not allow the patient to give informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Experimental

    Other intervention

    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).

Treatment groups

794 Participants
are divided into 2 treatment groups
Group A: Control armNo intervention 0 interventions
Group B: Interventional armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To assess the impact of reinforced multi-professional care pathway 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)

Time frame
over a maximum of 24 months after randomization

Secondary outcomes

1

Number of adverse events (NCI-CTCAE Version 6.0)

To evaluate the impact of the implementation of reinforced and multi-professional care pathway (oncologist, geriatrician, pharmacist, pharmacologist) in geriatric oncology.

Time frame
over 24 months, after randomization
2

Overall Survival

To evaluate the impact of the implementation of reinforced and multi-professional care pathway (oncologist, geriatrician, pharmacist, pharmacologist) in geriatric oncology.

Time frame
over 24 months, after randomization
3

Progression-Free Survival

To evaluate the impact of the implementation of reinforced and multi-professional care pathway (oncologist, geriatrician, pharmacist, pharmacologist) in geriatric oncology.

Time frame
over 24 months, after randomization
4

Quality of life questionnaires

To evaluate the impact of the implementation of reinforced and multi-professional care pathway (oncologist, geriatrician, pharmacist, pharmacologist) in geriatric oncology.

Time frame
over 24 months, after randomization

Other outcomes

Sponsors and contacts

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