Mifamurtide Combined With Post-operative Chemotherapy for Newly Diagnosed High Risk Osteosarcoma … (NCT03643133) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Mifamurtide Combined With Post-operative Chemotherapy for Newly Diagnosed High Risk Osteosarcoma Patients
France60 participantsStarted 2018-10-23
Plain-language summary
Trial evaluating the impact on efficacy of mifamurtide as add-on treatment to post-operative chemotherapy compared to post-operative chemotherapy alone in first-line treatment of patients with high-risk osteosarcoma (defined as metastatic osteosarcoma at diagnosis or localised osteosarcoma with poor histological response).
Who can participate
Age range50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patient with a histologically proven, confirmed by experts pathologists panel (before surgery at the latest), high-grade osteosarcoma
✓. Registered at diagnosis into the study
✓. Primary tumour resected after pre-operative chemotherapy
✓. Osteosarcoma classified as high risk because of at least one risk factor:
✓. presence of distant metastases or skip metastases at diagnosis
✓. and/or poor histological response to pre-operative chemotherapy (\>10% residual viable cells on the analysis of the primary tumour surgical specimen)
✓. Pre-operative chemotherapy combining
✓. Methotrexate-Etoposide-Ifosfamide (M-EI regimen) for patients ≤25 years
Exclusion criteria
✕. Low grade osteosarcoma, parosteal or periosteal osteosarcoma
✕. Prior history of other malignancies other than study disease (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the patient has been free of the disease for at least 3 years.
✕. Osteosarcoma with multiple metastases for whom complete removal is not expected to be feasible even after shrinkage with chemotherapy
✕. Progressive disease at any site under initial chemotherapy, confirmed before randomisation time, and not totally resected during surgery
What they're measuring
1
Compare event-free survival in the treatment arms
Timeframe: Expected average duration of 3 years from randomization
✕. Any medical condition precluding treatment with protocol chemotherapy
✕. Fractional Shortening \<28% or left ventricular ejection fraction (LVEF) 50% before treatment (only for API post-operative chemotherapy) by echocardiogram or multigated acquisition (MUGA) scan
✕. Pregnancy or breast-feeding
✕. Hypersensitivity to the active substance or to any of the excipients