Clinical Trial: Clinical Trial Evaluating Metronomic Chemotherapy in Patients With Metastatic Osteosarcoma
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
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
Brief 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 Summary: 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).
Sponsor: Grupo de Apoio ao Adolescente e a Crianca com Cancer
Current Primary Outcome: Efficacy and toxicity of adding metronomic therapy in disease event-free survival. [ Time Frame: Five years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Efficacy and toxicity of adding metronomic therapy in overall survival [ Time Frame: Five years ]To evaluate the impact of the addition of metronomic therapy to the standard treatment of patients with end-resectable osteosarcoma and metastatic lung disease in overall survival.
- Cardiotoxicity (occurrence of cardiotoxicity) [ Time Frame: Five years ]To compare the occurrence of cardiotoxicity with the addition of dexrazoxane since the first cycle of doxorubicin with the findings of the previous study (GLATO 2006).
- Immunohistochemistry (expression of VEGF) [ Time Frame: Five years ]Immunohistochemistry the expression of VEGF in the biopsy, primary tumor and metastases
Original Secondary Outcome: Same as current
Information By: Grupo de Apoio ao Adolescente e a Crianca com Cancer
Dates:
Date Received: January 27, 2017
Date Started: January 2, 2017
Date Completion: January 31, 2022
Last Updated: March 9, 2017
Last Verified: March 2017