Clinical Trial Evaluating Metronomic Chemotherapy in Patients With Metastatic Osteosarcoma (GLATO2017)
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|ClinicalTrials.gov Identifier: NCT03063983|
Recruitment Status : Recruiting
First Posted : February 24, 2017
Last Update Posted : March 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Osteosarcoma||Drug: Cyclophosphamide Drug: Methotrexate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||158 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||January 2, 2017|
|Estimated Primary Completion Date :||January 2, 2019|
|Estimated Study Completion Date :||January 31, 2022|
Experimental: Maintenance therapy
104 weeks of continuous oral low dose chemotherapy with cyclophosphamide (CPM) and methotrexate (MTX) following 31 weeks of MAP
Continuous oral cyclophosphamide
Continuous oral methotrexate
No Intervention: Control
31 weeks of MAP
- Efficacy and toxicity of adding metronomic therapy in disease event-free survival. [ Time Frame: Five years ]To assess the impact of adding metronome therapy to the standard treatment of patients with resectable end-stage osteosarcoma and metastatic lung disease in event-free survival.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03063983
|Contact: Antonio S Petrilli||+55 (11) firstname.lastname@example.org|
|Contact: Andreza A Senerchia||+55 (11) email@example.com|
|Study Chair:||Cláudia F Fontes||Grupo de Apoio ao Adolescente e a Crianca com Cancer|