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 study about?

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.

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 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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Paris – Hôpital Cochin Paris France
Hôpital Européen Georges-Pompidou Paris France
Centre Hospitalier Universitaire De Lille Lille France
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Centr Georges Francois Leclerc Dijon France
Aix Marseille University Marseille France
Institut Curie – Site Paris Paris France

Other Sites

Site Name City Country Status
Hospices Civils de Lyon_ Hôpital Fréderic Dugoujon Caluire Et Cuire France
Hdkvlvl Taehl Paris France
Cil Ccbgq Raegmxtazls Lyon France
Gzlvczt Rwxrfo Chevilly-Larue France
Cwlgip Df Lyefr Cypxci Lm Czcodg Ezmebi Mgkxpig Rennes France
Hdfhyhfh Fedfv Mrwv Emibjd Bron France
Coucpt Hfdecqqkljw Ltch Sga Pierre Benite France
Hanqevhu Ufnpedakfkmvrx Sjghwpdivm &yqjrpr Hwjkyqh dc Hywixhrdjuo STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
01.06.2026

Trial locations

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.

TRIFLURIDINE works together with tipiracil; it gets incorporated into the DNA of cancer cells and prevents them from copying their genetic material, also used for colorectal cancer.

OSIMERTINIB is a tablet that targets a specific mutation in the EGFR gene, which is found in some lung cancers, helping to stop tumor growth.

ENZALUTAMIDE blocks the effect of male hormones on prostate cancer cells, slowing the growth of this type of cancer.

PALBOCICLIB is another CDK4/6 inhibitor taken by mouth that helps control the growth of certain breast cancers by stopping cell division.

RIBOCICLIB also blocks CDK4 and CDK6 proteins, working similarly to other drugs in this class to treat breast cancer.

LENVATINIB is a pill that blocks several proteins that help tumors grow and make new blood vessels. It is used for cancers such as thyroid, kidney, and liver cancer.

BRIGATINIB targets a gene change called ALK that can drive lung cancer, helping to keep the cancer from growing.

EVEROLIMUS is an oral medication that inhibits a pathway called mTOR, which cancer cells use to grow and survive. It is used in a variety of cancers.

CABOZANTINIB blocks multiple signaling proteins that tumors need to grow and spread, and it is used for kidney and liver cancers.

SUNITINIB is a tablet that stops several receptors involved in blood‑vessel formation, slowing the growth of kidney cancer.

ALECTINIB HYDROCHLORIDE is an ALK inhibitor taken by mouth that treats lung cancers with ALK gene changes.

ABIRATERONE ACETATE reduces the body’s production of male hormones that can feed prostate cancer, helping to control the disease.

REGORAFENIB blocks many kinases that tumors use to grow and spread, and it is used for colorectal cancer and other solid tumors.

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.
Advanced gastrointestinal stromal tumor – a rare tumor arising from the connective tissue of the digestive tract that has spread beyond its original location. Cells proliferate and can invade surrounding organs and travel to the liver or peritoneum. The disease advances as tumors become larger and more numerous. It is characterized by ongoing growth of the stromal cells.
Advanced soft‑tissue sarcoma – a group of cancers that develop in muscles, fat, nerves, or blood vessels and have extended beyond the original site. Tumor cells infiltrate nearby tissues and can disseminate to lungs or other organs. Progression is marked by growth of the primary mass and appearance of distant metastases. The disease continues to expand despite local control.

Trial ID:
2025-523610-83-00
Protocol code:
CSET 2025/3840
Trial Phase:
Therapeutic confirmatory (Phase III)

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