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Effect of a multidisciplinary care pathway on safety of oral anticancer therapy in patients aged ≥70 with cancer (capecitabine and drug combination)

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study looks at older adults (age 70 and above) who have been diagnosed with cancer and are taking medicines that are swallowed as pills. In the breast group the oral medicines are Abemaciclib, Ribociclib, Palbociclib and Everolimus. The lung group uses Alectinib, Brigatinib and Osimertinib. The prostate group receives Abiraterone, Enzalutamide and Olaparib. For colon cancer the pills are Trifluridine together with Tipiracil, and also Capecitabine. Kidney‑related cancers are treated with Axitinib, Cabozantinib or Lenvatinib. Finally, the sarcoma/GIST group takes Sunitinib, Regorafenib or Pazopanib. All of these drugs are taken orally at home.

The purpose of the study is to see whether a coordinated care team made up of an oncologist, a geriatric doctor, a pharmacist and a pharmacologist can lower the number of serious side effects compared with usual care. Participants will start their oral medication and then have regular visits with the care team for up to two years. At each visit doctors will look for side effects, do blood tests, and ask about any problems that affect the blood (hematologic) or other parts of the body (non‑hematologic). A “grade ≥ 3” side effect means it is strong enough to need medical help, and a “grade ≥ 4” blood problem is very serious. The study also records any hospital stays, overall health, and quality‑of‑life questionnaires, while the pharmacist reviews all medicines to avoid unsafe combinations.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessment and start of oral medication

    After joining the study you will meet the oncologist, geriatrician, pharmacist and pharmacologist for an initial assessment.

    The team will confirm which oral anticancer drug is appropriate for your cancer type and will prescribe the medication at the dose shown below:

    breast cohort: abemaciclib 300 mg daily, ribociclib 600 mg daily, palbociclib 125 mg daily, everolimus 10 mg daily.

    lung cohort: alectinib 600 mg daily, brigatinib 180 mg daily, osimertinib 80 mg daily.

    prostate cohort: abiraterone acetate 1000 mg daily, enzalutamide 160 mg daily, olaparib 600 mg daily.

    colon cohort: capecitabine 5600 mg daily, trifluridine 160 mg daily together with tipiracil 160 mg daily.

    kidney cohort: axitinib 10 mg daily, cabozantinib 60 mg daily, lenvatinib 24 mg daily.

    sarcoma/gist cohort: sunitinib 50 mg daily, regorafenib 160 mg daily, pazopanib 800 mg daily.

    You will also complete the first quality‑of‑life questionnaire (eortc qlq‑c30 and euroqol eq5d‑5l) at this visit.

  2. Step 2

    Daily intake of the prescribed oral medication

    Take the assigned oral medication each day at the same time, unless your doctor tells you otherwise.

    Keep a list of all medicines you are using, including the cancer drug and any other prescriptions or over‑the‑counter products.

    If you miss a dose, follow the instructions given by the pharmacist on how to handle a missed dose.

  3. Step 3

    First oncologist visit at month 1

    One month after starting the medication you will have a scheduled visit with the oncologist.

    During this visit you will report any side effects, new symptoms, or hospital admissions that have occurred.

    The oncologist will assess for any grade ≥3 non‑hematologic adverse event or grade ≥4 hematologic adverse event using the national cancer toxicity criteria.

    The pharmacist may also review your medication list and suggest adjustments if needed.

  4. Step 4

    Regular follow‑up visits every three months

    Starting at month 3, you will attend oncologist appointments every three months (month 3, 6, 9, 12, 15, 18, 21, and 24).

    Each visit includes evaluation of side effects, recording of any adverse events, and discussion of treatment continuation.

    The team will also note any hospitalizations that occurred since the previous visit.

    If the oral medication needs to be stopped or changed, the decision will be made together with the oncologist.

  5. Step 5

    Quality‑of‑life questionnaires at scheduled times

    You will complete the eortc qlq‑c30 and euroqol eq5d‑5l questionnaires at baseline (month 0), month 1, month 3, month 6, month 12, and month 24.

    These questionnaires ask about physical function, symptoms, and overall health perception.

    The results help the study team understand how the treatment affects your daily life.

  6. Step 6

    Pharmacist and pharmacologist medication review

    At baseline and again at month 3 the pharmacist will perform a detailed review of all drugs you are taking.

    The review looks for potentially inappropriate prescriptions and assesses the overall complexity of your medication regimen using a standard scoring system.

    The pharmacologist may suggest changes to improve safety and reduce drug interactions.

  7. Step 7

    Study completion or early discontinuation

    The trial continues for up to 24 months from the day you start the oral medication.

    If you experience a severe adverse event, decide with your oncologist to stop the study drug, or reach a point where the medication is no longer effective, the study may end for you earlier.

    At the final visit you will have a last assessment of side effects, quality of life, and overall outcome.

Who can join the trial?

10 criteria

  • Age: You must be 70 years old or older.
  • Social security coverage: You need to be part of a social security system or receive its benefits.
  • G8 score of 14 or lower (the G8 is a short questionnaire that helps doctors see if an older person may need extra health checks).
  • Performance status of 3 or lower (this measures how well you can carry out daily activities; a lower number means you are more able).
  • You must have a locally advanced or metastatic solid tumor in one of these groups: breast, lung, prostate, colon, kidney, or sarcoma/GIST.
  • You must be planning to start an oral anticancer medicine (taken by mouth) such as the listed drugs for each cancer type.
  • If you are a woman who cannot become pregnant, or you have a negative pregnancy test taken within the past 14 days, you meet the requirement. If you can become pregnant, you must agree to use a condom plus another reliable birth‑control method during the study and for up to 6 months after the last dose.
  • If you are a sexually active man, you must agree to use a condom during the study and for at least 6 months after the last dose; your partner who can become pregnant should also use a reliable birth‑control method.
  • You must sign a written, dated and dated informed consent form before any study procedures are done.
  • You must be able to follow the study’s required visits and procedures.

Who cannot join the trial?

8 criteria

  • Patients who have already taken or are currently taking the oral therapy (medicine taken by mouth) being studied cannot join.
  • Patients who have severe side effects rated as grade 3 or 4 toxicity (serious adverse reactions according to a standard cancer grading system) that make the oral medication unsafe are excluded.
  • Patients who are unable to follow the treatment plan, such as taking the medication as directed, cannot participate.
  • Patients with a mental or psychological illness that prevents them from giving informed consent (understanding the study and agreeing to it) are not eligible.
  • Patients who have already received specialized oncogeriatric care (cancer care specially designed for older adults) within the past 12 months are excluded.
  • Patients who have already had a special pharmacological dosage (adjusted dose) for the oral medication being studied cannot join.
  • Patients with any other serious medical problem, unresolved side effects from a previous experimental treatment, or any condition that could make participation unsafe or affect study procedures are not allowed to enroll.
  • Patients who are under legal guardianship, are deprived of liberty by a court decision, or cannot give consent for any reason are excluded.
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Investigated drugs

  • ABEMACICLIB

    is a pill that blocks proteins called CDK4 and CDK6, which help cancer cells grow. By stopping these proteins, the drug slows the growth of certain breast cancers.

  • PAZOPANIB

    is an oral medicine that blocks signals that tell tumors to make new blood vessels. Without these vessels, the tumor has less blood supply and grows more slowly.

  • CAPECITABINE

    is a chemotherapy taken by mouth that is changed inside the body into a drug similar to 5‑fluorouracil. It interferes with the DNA of cancer cells, stopping them from dividing.

  • AXITINIB

    is a tablet that blocks a protein called VEGF receptor, which cancers use to grow new blood vessels. It is used mainly for kidney cancer.

  • OLAPARIB

    is a pill that stops cancer cells from repairing their DNA. It works best in cancers that have certain gene changes, such as some breast, ovarian, and prostate cancers.

  • TIPIRACIL

    is an oral drug that disrupts the building blocks of DNA in cancer cells, helping to stop their growth, especially in colorectal cancer.

What is already known about the treatment

  • Abemaciclib

    This drug is taken by mouth as a tablet. It is an approved cancer medicine that is widely described in clinical studies. It is mainly used for certain types of breast cancer. It works by blocking proteins called CDK4 and CDK6 that help cancer cells grow, and it is classified as a CDK4/6 inhibitor.

  • Pazopanib

    Pazopanib is an oral capsule taken daily. It is an approved therapy for kidney cancer and some soft‑tissue sarcomas and is well documented in the literature. It stops tumor growth by inhibiting several tyrosine‑kinase enzymes that signal blood‑vessel formation. It belongs to the class of tyrosine‑kinase inhibitors.

  • Capecitabine

    Capecitabine comes as an oral tablet that patients swallow. It is an approved chemotherapy drug used for colon and breast cancers and has extensive clinical data. Inside the body it is changed into 5‑fluorouracil, which interferes with DNA building blocks, stopping cancer cells from dividing. It is classified as an antimetabolite chemotherapy.

  • Axitinib

    Axitinib is taken as an oral tablet. It is an approved treatment for kidney cancer and is well studied in medical research. It blocks the VEGF receptor tyrosine‑kinases, which reduces blood‑vessel growth that feeds tumors. It is a vascular endothelial growth factor receptor (VEGFR) tyrosine‑kinase inhibitor.

  • Olaparib

    Olaparib is an oral capsule. It is an approved drug for certain prostate and ovarian cancers and is widely reported in trials. It works by blocking an enzyme called PARP that helps repair DNA, so cancer cells with faulty DNA repair die. It is classified as a PARP inhibitor.

  • Tipiracil

    Tipiracil is taken as an oral tablet, usually combined with trifluridine. It is an approved therapy for advanced colon cancer and has solid evidence in the literature. It prevents the breakdown of trifluridine, allowing more of the active drug to stay in the body and damage cancer DNA. It is part of a combination antimetabolite regimen.

Investigated diseases

  • Hormone receptor‑positive, HER2‑negative advanced breast cancer

    a type of breast cancer that grows in response to estrogen or progesterone and does not overexpress HER2. It spreads beyond the breast and may involve lymph nodes or distant sites. The tumor cells continue to divide, leading to gradual increase in size or new lesions. Disease can progress despite hormone therapy.

  • ALK‑positive non‑small cell lung cancer

    a subset of lung cancer where tumor cells contain an abnormal ALK gene that drives growth. It usually presents as a tumor in the lung that can spread to nearby lymph nodes and distant organs. The cancer cells divide rapidly, leading to enlargement of the primary lesion and appearance of metastases. Over time, the disease may become more widespread.

  • EGFR‑mutated non‑small cell lung cancer

    lung cancer driven by mutations in the EGFR gene. The tumor often starts in the airway lining and can extend into surrounding lung tissue and spread. Cancer cells proliferate, causing the tumor to grow and potentially form new sites in other organs. Disease progression is marked by increasing tumor burden.

  • Metastatic castration‑resistant prostate cancer

    prostate cancer that continues to grow despite lowering testosterone levels and has spread beyond the prostate. Cancer cells invade nearby tissues and distant sites such as bone. The disease advances as new lesions appear and existing ones enlarge. It is characterized by ongoing growth without hormonal control.

  • Metastatic colorectal cancer

    cancer that began in the colon or rectum and has spread to other parts of the body, often liver or lungs. Tumor cells detach, travel through blood or lymph, and form new tumors. The disease progresses as these secondary tumors increase in size and number. It reflects continuous spread of malignant cells.

  • Advanced renal cell carcinoma

    kidney cancer that has grown beyond the kidney and may involve blood vessels, lymph nodes, or distant organs. Tumor cells form new blood vessels to support growth, allowing the tumor to enlarge and spread. Disease progression is seen as larger kidney masses and new metastatic sites. It is a slow‑growing but invasive cancer.

Trial detailsLast updated 2 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2025-523610-83-00Protocol codeCSET 2025/3840Estimated enrolment794 patientsSponsorInstitut Gustave Roussy

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).