NCT03063983

Clinical Trial Evaluating Metronomic Chemotherapy in Patients With Metastatic Osteosarcoma

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: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 158 (estimated)
• Sponsor: Grupo de Apoio ao Adolescente e a Crianca com Cancer · Academic / Other
• Sex: All
• Age: 1 Day – 30 Years
• Healthy volunteers: Not accepted

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

Detailed 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).

Conditions

• Osteosarcoma

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Continuous oral cyclophosphamide
DRUG	Methotrexate	Continuous oral methotrexate

Timeline

• Start date: 2017-01-02
• Primary completion: 2019-01-02
• Completion: 2022-01-31
• First posted: 2017-02-24
• Last updated: 2017-03-13

Locations

1 site across 1 country: Brazil

Regulatory

• FDA-regulated drug study