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Clinical Trial Summary

Preclinical models show that a daily antiangiogenic regimen at low-dose may be effective against chemotherapy-resistant tumors. The aim of this study is to evaluate the efficacy of maintenance therapy with continuous oral cyclophosphamide and methotrexate in patients with high grade, operable, metastatic osteosarcoma (OST) of the extremities. The primary end point is event-free survival (EFS) from randomization


Clinical Trial Description

The study design includes backbone of 10 weeks of preoperative therapy using MAP (high-dose methotrexate, cisplatin, doxorubicin and dexrazoxane). Metastatic patients were randomized to high-dose chemotherapy for 31 weeks (arm 1) or concomitant metronomic therapy (MTX plus cyclophosphamide) such as 31 weeks of high-dose chemotherapy, followed by 73 weeks of metronomic therapy after completion of high-dose chemotherapy, totaling 104 weeks of metronomic therapy (arm 2). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03063983
Study type Interventional
Source Grupo de Apoio ao Adolescente e a Crianca com Cancer
Contact Antonio S Petrilli
Phone +55 (11) 5080-8400
Email sergiopetrilli@graacc.org.br
Status Recruiting
Phase Phase 2
Start date January 2, 2017
Completion date January 31, 2022

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