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

NCT03643133 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-19

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Mifamurtide

48 doses overall over 36 weeks

COMBINATION_PRODUCT

EI or M-API regimen depending on patient age

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

Sponsors & Collaborators

  • UNICANCER

    lead OTHER

Principal Investigators

  • Nathalie MD GASPAR, PhD · Gustave Roussy Cancer Campus

  • Sophie MD PIPERNO-NEUMANN, PhD · Institut Curie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-23
Primary Completion
2026-09-30
Completion
2033-10-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03643133 on ClinicalTrials.gov