Can a coordinated care team reduce severe side effects in older cancer patients?

NCT ID NCT07802847

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This trial tests whether a coordinated care pathway, involving oncologists, geriatricians, pharmacists, and pharmacologists, can reduce severe side effects in adults over 70 with certain cancers who are starting oral therapy. Participants receive extra monitoring, including blood tests to check drug levels, medication reviews, and frailty assessments. The goal is to see if this approach improves treatment safety and quality of life compared to standard care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A coordinated care pathway combining oncogeriatric, pharmaceutical, and pharmacological follow-up, including blood tests to adjust drug doses, medication reviews, and frailty monitoring.
What this could lead to
If it works, this approach could reduce severe side effects and improve quality of life for older adults taking oral cancer drugs.
What could go wrong
The trial is large but still early in testing a care model, not a drug. Benefits may vary by cancer type, and the extra monitoring could be hard to roll out broadly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 794 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

70 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Gustave Roussy

    Villejuif, 94805, France

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