Badanie skuteczności cabozantinibu jako terapii podtrzymującej u pacjentów z osteosarcomą po pierwszej chemioterapii

Enrollment and consent

After joining the study you sign a consent form that explains the purpose and procedures.

The research team confirms that you meet the inclusion Criteria for osteosarcoma.

Baseline assessments

You undergo clinical examinations, blood tests, and imaging studies (such as X‑ray, CT, or MRI) to document the current status of the disease.

The collected information is used to plan the next steps of treatment.

Randomization

Based on a computer‑generated allocation you are assigned either to cabozantinib (the study medication) or to best supportive care (standard non‑drug management).

The assignment is made without your influence and is recorded in the study database.

Start of maintenance therapy – cabozantinib arm

If you are assigned to the cabozantinib Group you begin oral treatment with cabometyx 60 mg film‑coated tablets.

The tablet is taken once daily, preferably at the same time each day, with water and without regard to meals.

Treatment continues for up to three years, or until disease progression, unacceptable toxicity, or withdrawal of consent.

Start of maintenance therapy – best supportive care arm

If you are assigned to best supportive care you receive routine medical follow‑up, symptom management, and any necessary supportive medications, but no study drug.

Regular follow‑up visits

You attend study visits every four weeks for safety Assessment, which includes physical Examination, blood tests, and review of any side effects.

Imaging studies to evaluate the tumor are performed approximately every twelve weeks.

Monitoring and management of side effects

Any adverse event (new symptom or worsening of an existing symptom) is recorded.

For severe side effects (grade 3 or higher) the study protocol may require dose reduction, temporary interruption, or discontinuation of cabozantinib.

The medical team provides instructions on how to manage common side effects such as diarrhea, fatigue, or hypertension.

Dose adjustments (cabozantinib arm only)

If toxicity occurs the dose may be reduced to 40 mg daily, and later to 20 mg daily, following the study guidelines.

Dose reductions are documented and the next scheduled visit confirms tolerability.

Assessment of disease status

At each imaging time point the investigators evaluate whether the disease has progressed, remained stable, or entered remission.

The primary outcome of the study is event‑free survival, defined as the time from randomisation to the first occurrence of disease progression, relapse, a new cancer, or death.

Study completion or early discontinuation

The study ends for you after three years of treatment, if the disease progresses, if unacceptable toxicity forces discontinuation, or if you choose to withdraw consent.

A final Assessment records overall health status, survival, and quality‑of‑life questionnaires.