Feasibility Study of Interval Compressed Regimen Using Four-drugs for Osteosarcoma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Toxicity determined according to CTCAE
研究概览
简要总结
The aim of the study is to test the feasibility of four-drug, interval-compressed regimen in osteosarcoma.
Primary objective is to explore the toxicity and mortality related to treatment. Secondary objectives are to examine tumor necrosis rates after neoadjuvant chemotherapy, and to evaluate the usefulness of circulating cell-free DNA, survivin, or transforming growth factor-beta1 levels as well as programmed cell death ligand 1 expression in tumor specimen as a predictive or prognostic biomarker in osteosarcoma patients.
详细描述
In this study, the investigators will investigate the feasibility of interval compressed regimen using four-drugs in newly-diagnosed osteosarcoma patients. Four drugs will be adriamycin, high-dose methotrexate, cisplatin, ifosfamide. All these drugs will be given preoperatively in an interval-compressed schedule, but postoperatively at a regular interval. Neoadjuvant therapy will be composed of two courses, and adjuvant therapy of two or three courses depending on necrosis rates following neoadjuvant therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed osteosarcoma patients under age 40 years.
排除标准
- •Patients who don't meet the organ function criteria as follows;
- •renal function : CCr or GFR or eGFR ≥ 70 mL/min/1.73 m2
- •liver function : AST/ALT ≤ 5 x upper limit, total bilirubin ≤ 1.5 x upper limit of normal for age
- •cardiac function : shortening fraction ≥ 24% or ejection fraction ≥ 50% (Echo)
- •lung function : No dyspnea on rest, If dyspnea exists, SpO2 95% or more in room air by pulse oximetry,
- •hematologic : ANC ≥ 750/uL and platelet ≥ 75,000/uL
研究组 & 干预措施
four-drug interval-compressed regimen
Interventions for 'four-drug interval-compressed regimen': Drug: methotrexate, cisplatin, doxorubicin, ifosfamide.
Newly diagnosed oseteosarcoma patients under 40 years are eligible. Neoadjuvant chemotherapy with four drugs in an interval-compressed schedule will be done as a single arm.
Duration of neoadjuvant chemotherapy will be 10 weeks like that of conventional three-drug regimen, although four-drugs are employed in the current protocol.
After tumor resection operation, participants will be divided to poor responder group and good responder group based on 90% necrosis rate of a tumor specimen.
Poor responder group and will be assigned to 'Poor responder group adjuvant chemotherapy' and good responder will be assigned to 'Good responder group adjuvant chemotherapy'.
干预措施: Poor responder group adjuvant chemotherapy (Drug)
four-drug interval-compressed regimen
Interventions for 'four-drug interval-compressed regimen': Drug: methotrexate, cisplatin, doxorubicin, ifosfamide.
Newly diagnosed oseteosarcoma patients under 40 years are eligible. Neoadjuvant chemotherapy with four drugs in an interval-compressed schedule will be done as a single arm.
Duration of neoadjuvant chemotherapy will be 10 weeks like that of conventional three-drug regimen, although four-drugs are employed in the current protocol.
After tumor resection operation, participants will be divided to poor responder group and good responder group based on 90% necrosis rate of a tumor specimen.
Poor responder group and will be assigned to 'Poor responder group adjuvant chemotherapy' and good responder will be assigned to 'Good responder group adjuvant chemotherapy'.
干预措施: Good responder group adjuvant chemotherapy (Drug)
结局指标
主要结局
Toxicity determined according to CTCAE
时间窗: Until study completion, an average of 3 years
treatment-related toxicity (organ dysfunction, neutropenic fever, infection, mortality, et al.)
次要结局
- tumor necrosis rate(Until study completion, an average of 3years)
- Predictive or prognostic biomarker(Until study completion, an average of 3 years)
研究者
Byung-Kiu Park
Prof.
National Cancer Center, Korea