NCT02273583

Prospective Clinical Trial Evaluating Metronomic Chemotherapy in Patients With High-grade, Operable, Non-metastatic Osteosarcoma of the Extremity

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 738 (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, non-metastatic osteosarcoma (OST) of the extremities. The primary end point is event-free survival (EFS) from randomization.

Detailed description

The study design includes a backbone of 10 weeks of preoperative therapy using MAP (High-dose methotrexate, cisplatin, and doxorubicin). Following surgery, non-metastatic patients were randomized by blocks to complete 31 weeks of MAP or to receive 73 weeks of maintenance therapy following MAP; while metastatic patients received maintenance therapy in combination with MAP since the beginning of treatment.

Conditions

• High Grade Osteosarcoma

Interventions

Type	Name	Description
DRUG	continuous oral cyclophosphamide and methotrexate

Timeline

• Start date: 2006-05-01
• Primary completion: 2013-06-01
• First posted: 2014-10-24
• Last updated: 2016-02-11

Locations

1 site across 1 country: Brazil