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
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Efficacy and toxicity of adding metronomic therapy in disease event-free survival.
研究概览
简要总结
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
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A newly diagnosed patient, previously untreated, with a high degree of malignancy, confirmed by biopsy. Participant with OST as a neoplasm are also eligible
- •Participant with staging imaging studies performed less than four weeks. Otherwise, it should be re-staged
- •If pre-chemotherapy amputation is necessary, the participant will enter the study being excluded from the evaluation of tumor necrosis grade according to Huvos, but eligible for survival analysis
- •Participant aged ≥ 16 years should have a Karnofsky performance score> 50 or WHO / ECOG ≥ 2 and patients <16 years should have a Lansky performance score>
- •Participant with a performance score impaired by the presence of a pathological fracture are eligible
- •Patients with normal organic function
- •Sexually active participant should agree to use contraceptive methods throughout the treatment
- •Female participant should have a negative pregnancy test
排除标准
- •If the participant or their legal guardian refuses to sign the informed consent form / consent term it will not be included in the study.
研究组 & 干预措施
Maintenance therapy
104 weeks of continuous oral low dose chemotherapy with cyclophosphamide (CPM) and methotrexate (MTX) following 31 weeks of MAP
干预措施: Cyclophosphamide (Drug)
Maintenance therapy
104 weeks of continuous oral low dose chemotherapy with cyclophosphamide (CPM) and methotrexate (MTX) following 31 weeks of MAP
干预措施: Methotrexate (Drug)
结局指标
主要结局
Efficacy and toxicity of adding metronomic therapy in disease event-free survival.
时间窗: 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.
次要结局
- Efficacy and toxicity of adding metronomic therapy in overall survival(Five years)
- Cardiotoxicity (occurrence of cardiotoxicity)(Five years)
- Immunohistochemistry (expression of VEGF)(Five years)
研究者
Antônio Sérgio Petrilli
Principal Investigator
Grupo de Apoio ao Adolescente e a Crianca com Cancer