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Clinical Trial 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).


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03643133
Study type Interventional
Source UNICANCER
Contact
Status Active, not recruiting
Phase Phase 2
Start date October 23, 2018
Completion date October 2033

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