Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Osteosarcoma

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Sarcoma

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Etoposide

Doxorubicin

Liposomal doxorubicin

Methotrexate

Cisplatin

Ifosfamide

Etoposide phosphate

Isophosphamide mustard

Mifamurtide

Acetylmuramyl-Alanyl-Isoglutamine

Adjuvants, Immunologic

Immunologic Factors

Post-operative chemotherapy alone (EI or M-API regimen depending on patient age) :

M-API regimen (≤25 years) :

Doxorubicin 60 mg/m², Day 1 Ifosfamide 3 g/m² Day 1 and 2 Cisplatin 100 mg/m², Day 2

EI regimen (26-50 years) :

Etoposide 75 mg/m²/d, Day 1-4 Ifosfamide 3 g/m²/d, Day 1-4

Post-operative chemotherapy (EI or M-API regimen) combined with Mifamurtide 2 mg/m² twice weekly post-randomisation for 12 weeks then weekly for 24 weeks

M-API regimen:

One course of high-dose Methotrexate (optional) followed by 5 courses of API, every 21 days

EI regimen :

5 course of EI, every 21 days

EI or M-API regimen depending on patient age

Nathalie MD GASPAR, PhD

Sophie MD PIPERNO-NEUMANN, PhD

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).

Multicentre, randomised, open-label, phase II trial, with 2 parallel groups. After pre-operative chemotherapy and surgery of the primary tumour and lung metastases (if applicable), patients presenting high-risk osteosarcoma (defined as metastatic osteosarcoma at diagnosis or localised osteosarcoma with poor histological response) will be randomised between 2 arms:

* Control arm: post-operative chemotherapy alone (with regimens adapted to the age of patient)
* Experimental arm : post-operative chemotherapy combined with mifamurtide

This randomised trial is part of a study recruiting all patients ≤50 years old with a newly diagnosed high-grade osteosarcoma.

Mifamurtide Combined With Post-operative Chemotherapy for Newly Diagnosed High Risk Osteosarcoma Patients

Multicentre, Randomised, Phase 2 Trial of Mifamurtide Combined With Post-operative Chemotherapy for Newly Diagnosed High Risk Osteosarcoma Patients (Metastatic Osteosarcoma at Diagnosis or Localised Disease With Poor Histological Response)

Individual participant data will not be shared at an individual level, they will be part of the study database including all enrolled patients.

Event-free survival defined as the time duration from randomisation to time of first event (loco-regional or distant relapse or progression, second malignancy, death from any cause)

Overall survival defined as the time duration from randomisation to death, whatever the cause of death

Calculation of actual cumulative dose and dose intensity compared to the planned treatment administration schedule

Evaluation of toxicity (graded by NCI-CTCAE v4)

Spots Global Cancer Trial Database for neoplasm, bone tissue