Clinical Trial Evaluating Metronomic Chemotherapy in Patients With Metastatic Osteosarcoma — GLATO2017  

Osteosarcoma Clinical Trial

Official title: A Study Multicenter Randomized to Assess the Efficacy and Toxicity of Adding Metronomic Therapy to the Standard Treatment of Patients With High Grade Malignant Osteosarcoma With Metastatic Lung Disease at Diagnosis and Primary Resectable Tumor: A Study by the Latin American Group for Treatment of Osteosarcoma

Status Recruiting

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). ;

Related Conditions & MeSH terms

• Osteosarcoma

• 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