ElderlyPhase 4POGNCT07802847
Innovative and Cooperative Pathway Integrating Oncogeriatric, Pharmaceutical and Pharmacological Follow-up in Elderly Patients.
A Phase 4 study testing Experimental in people with Elderly and Breast Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Elderly, Breast Cancer, Lung Cancer
- What is being tested?
- Experimental
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 794 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2026to Sep 2031
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Gustave Roussy
Villejuif, 94805
Arnaud BAYLE, 01 42 11 53 89 ext. +33, arnaud.bayle@gustaveroussy.fr
About this study
Official 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.
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
- Elderly, Breast Cancer, Lung Cancer, Prostate Cancer, Colon Cancer, Kidney Cancer
- Being tested
- Experimental
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Prostatic Neoplasms, Colonic Neoplasms, Kidney Neoplasms, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | Initial oncogeriatric evaluation then standard follow-up according to the current practices of the center. |
| Interventional arm | Experimental | Initial oncogeriatric evaluation then Oncogeriatric, pharmaceutical and pharmacological follow-up. Receives: Other: Experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: over a maximum of 24 months after randomization
Secondary outcomes (4)
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.
Measured: over 24 months, after randomization
Overall Survival
To evaluate the impact of the implementation of reinforced and multi-professional care pathway (oncologist, geriatrician, pharmacist, pharmacologist) in geriatric oncology.
Measured: over 24 months, after randomization
Progression-Free Survival
To evaluate the impact of the implementation of reinforced and multi-professional care pathway (oncologist, geriatrician, pharmacist, pharmacologist) in geriatric oncology.
Measured: over 24 months, after randomization
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.
Measured: over 24 months, after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2031 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 794 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802847
- Sponsor's protocol ID
- 2025-523610-83-00
- Other IDs
- CSET number 2025 / 3840, 2025
- Acronym
- POG
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07802847
- Acronym / sponsor ID
- POG / 2025-523610-83-00
- Conditions
- Elderly, Breast Cancer, Lung Cancer, Prostate Cancer, Colon Cancer, Kidney Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 794 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2031 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –Initial oncogeriatric evaluation then standard follow-up according to the current practices of the center. |
| Interventional arm | Experimental | Other: ExperimentalInitial oncogeriatric evaluation then Oncogeriatric, pharmaceutical and pharmacological follow-up. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (16 listed)
- 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:
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExperimentalPharm-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). | Other | Interventional arm |
Primary outcome
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
4 secondary outcomes
Number of adverse events (NCI-CTCAE Version 6.0)
Time frame: over 24 months, after randomization
Overall Survival
Time frame: over 24 months, after randomization
Progression-Free Survival
Time frame: over 24 months, after randomization
Quality of life questionnaires
Time frame: over 24 months, after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Experimental in people with Elderly and Breast Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arnaud BAYLE (01 42 11 53 89 ext. +33, arnaud.bayle@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.