Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07802847

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

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Elderly Breast Cancer Breast Diseases Breast Neoplasms Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Intestinal Diseases Intestinal Neoplasms Kidney Cancer Kidney Diseases Kidney Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Prostate Cancer Prostatic Diseases Prostatic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • With a decision to initiate treatment with oral therapy (Tyrosine Kinase Inhibitor, Hormone Therapy, chemotherapy) 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 agreed to use one barrier method of contraception, such as condom, plus an additional highly effective method of contraception during treatment on this trial an for up to 6 month after the last dose of study treatment
  • Sexually active males patients must agree to use condom during the clinical investigation and for at least 6 months after the study treatment. Also, it is recommended the childbearing potential female partner uses a highly effective method of contraception for the same duration
  • Written, dated and signed informed consent by the patient prior to any specific protocol procedure
  • Ability to comply with the protocol procedures
  • Patients must be affiliated to a social security system or beneficiary of the same

Exclusion criteria

  • 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
  • Patient who has already benefited from specialized oncogeriatric care in the last 12 months
  • Patient who has already benefited from a pharmacological dosage for the oral therapy studied
  • Presence of a pathology or condition that makes the patient's participation in the study inappropriate which includes serious unresolved or unstable toxicities from previous administration of another investigational treatment or any medical condition that could interfere with patient safety, obtaining consent, or compliance with study procedures
  • Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent

Treatment and study plan

Experimental

Other

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).

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)

    Time frame: over 24 months, after randomization

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

  2. Overall Survival

    Time frame: over 24 months, after randomization

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

  3. Progression-Free Survival

    Time frame: over 24 months, after randomization

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

  4. Quality of life questionnaires

    Time frame: over 24 months, after randomization

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

Study contacts

Contact information is provided by the study sponsor or research team.

Arnaud BAYLE

CONTACT

[email protected]

01 42 11 53 89 ext. +33

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Registry information

Official study title

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.

Acronym: POG

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.