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Study on the Effectiveness of Denosumab with Chemotherapy (Cisplatin, Methotrexate, Doxorubicin) for Patients with Metastatic Osteosarcoma

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What is this trial about?

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

This clinical trial is focused on studying the treatment of metastatic osteosarcoma, a type of bone cancer that has spread to other parts of the body. The study will explore the effectiveness of a medication called denosumab when used in combination with standard chemotherapy drugs. The chemotherapy regimen includes cisplatin, methotrexate, and doxorubicin hydrochloride. These medications are commonly used to treat various types of cancer and are administered through intravenous infusion or injection.

The purpose of this study is to evaluate how well the combination of denosumab and standard chemotherapy works in treating patients with metastatic osteosarcoma. Participants in the study will be randomly assigned to receive either the standard chemotherapy regimen alone or the standard chemotherapy regimen combined with denosumab. The study will be conducted over a period of time, with regular monitoring to assess the treatment's effectiveness and any side effects experienced by the participants.

The trial aims to determine if the addition of denosumab can improve outcomes for patients with metastatic osteosarcoma. The primary focus is on measuring the 5-year event-free survival, which refers to the time patients remain free from cancer progression or recurrence. This study is an important step in finding more effective treatments for this aggressive form of cancer.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and performing necessary tests to ensure adequate bone marrow, liver, and kidney function.

    A pregnancy test is required for female patients of childbearing age. This test must be negative before starting each chemotherapy cycle.

  2. Step 2

    Treatment phase

    The treatment involves a combination of standard chemotherapy and the medication denosumab. The chemotherapy regimen includes cisplatin, methotrexate, and doxorubicin hydrochloride, all administered through intravenous infusion.

    The medication denosumab is also administered intravenously. The specific dosage and frequency of administration are determined by the study protocol and the patient's response to treatment.

  3. Step 3

    Monitoring and follow-up

    Regular monitoring is conducted to assess the effectiveness of the treatment and to manage any side effects. This includes routine blood tests and imaging studies.

    The primary goal is to evaluate the 5-year event-free survival, which refers to the absence of disease progression or recurrence.

  4. Step 4

    End of study

    The study is estimated to conclude by April 6, 2031. At the end of the study, a final assessment is conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who can join the trial?

15 criteria

  • The patient or their legal representative must be able to read and understand the informed consent form and must provide written consent before any trial-specific procedure.
  • The patient must have a confirmed diagnosis of high-grade **metastatic osteosarcoma** at the start. **Metastatic osteosarcoma** is a type of bone cancer that has spread to other parts of the body.
  • The patient must be between the ages of 12 and 40 years or have reached **skeletal maturity**, which means their bones have fully developed.
  • The patient must have an **ECOG Performance status** of 2 or less, or a **Lansky Score** of 40% or more. These are scales used to measure how well a patient can perform daily activities.
  • The patient must have adequate **bone marrow function**, which means:
    • White blood cells greater than 3.0 x 109/L
    • Absolute neutrophil count greater than 1.5 x 109/L
    • Platelets greater than 100 x 109/L
    • Hemoglobin greater than 9 g/dL
    • The patient must have adequate **liver and kidney function**, which means:
      • Total bilirubin less than 2 times the upper limit of normal
      • AST (SGOT) and ALT (SGPT) less than 3 times the upper limit of normal
      • GGT less than 2.5 times the upper limit of normal
      • Blood calcium between 8.0 mg/dL and 11.5 mg/dL
      • Creatinine levels below 1.5 mg/mL or a creatinine clearance of 60 mL/min/1.73m2 for those with higher creatinine levels
      • The patient must have a **Left Ventricular Ejection Fraction** greater than 50%. This is a measure of how well the heart is pumping blood.
      • Female patients of childbearing age must have a negative pregnancy test within 7 days before starting each chemotherapy cycle. Post-menopausal women must not have had a period for at least 12 months to be considered potentially infertile. Both male and female patients who can have children must agree to use an effective method of birth control during the study.

Who cannot join the trial?

3 criteria

  • Patients who do not have metastatic osteosarcoma. This means the cancer has spread from the bone to other parts of the body.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Denosumab

    is a medication used in this trial to evaluate its effectiveness when combined with standard chemotherapy for treating patients with metastatic osteosarcoma. It works by targeting a specific protein involved in bone destruction, potentially helping to prevent the spread of cancer to the bones.

  • MAP Chemotherapy

    is a standard treatment regimen for osteosarcoma that includes a combination of three chemotherapy drugs: methotrexate, doxorubicin, and cisplatin. This combination is used to kill cancer cells and shrink tumors, aiming to improve patient outcomes in those with metastatic osteosarcoma.

What is already known about the treatment

Denosumab – This medication is administered via injection under the skin. It is currently being studied in clinical trials for its effectiveness in treating metastatic osteosarcoma, a type of bone cancer. Denosumab works by targeting and inhibiting a protein involved in bone breakdown, which may help in reducing bone complications associated with cancer. It is classified as a monoclonal antibody, specifically designed to interfere with the activity of certain cells that break down bone tissue.

Investigated diseases

Metastatic Osteosarcoma – This is a type of bone cancer that has spread from its original site to other parts of the body, such as the lungs or other bones. It typically begins in the cells that form bones and is most common in teenagers and young adults. The disease progresses as cancer cells travel through the bloodstream or lymphatic system to establish new tumors in distant organs. Symptoms may include bone pain, swelling, and fractures. As the disease advances, it can lead to decreased mobility and other complications depending on the areas affected by metastasis.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518167-35-01Protocol codeAIEOP-ISG OsM+Estimated enrolment88 patientsSponsorAssociazione Italiana Ematologia Oncologia Pediatrica

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