The Therapeutic Effect of Single High-dose Brachytherapy for Locally Inoperable and Metastatic Giant Osteosarcoma Masses
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 16
- 主要终点
- progression-free survival
研究概览
简要总结
This study is a prospective, single-arm, phase II, single-center study. Patients with locally unresectable giant osteosarcoma masses who meet the criteria are enrolled in the experimental group, and all patients receive a single dose of 10Gy of implantable brachytherapy. Record treatment-related acute events during and after treatment. Follow up on survival and local control after treatment ends, marking the end of the trial treatment.
详细描述
Screening period: Local MRI or CT examination, blood routine and coagulation function test.
Selected treatment period: All enrolled patients received one dose of close range interstitial radiotherapy with a radiation dose of 10 Gy. The number of insertion needles depends on the size and location of the tumor. The instrument used for radiotherapy is the Medda high-dose rate brachytherapy machine, and the radiation source is 192 iridium. Record treatment related acute events such as bleeding during the treatment period.
Follow up: Follow up with local MRI or CT at 1 month, 3 months, 6 months, and 1 year after the end of radiotherapy treatment to evaluate the treatment effect; Simultaneously follow up with patients for survival and treatment related adverse reactions, such as dermatitis, infections, etc.
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
- 12 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathological diagnosis of osteosarcoma;
- •Age range 12-70 years old;
- •The primary or metastatic lesion cannot be surgically removed based on clinical evaluation, and treatment with internal medicine multi line chemotherapy, targeted therapy, immunotherapy, etc. is ineffective;
- •ECOG physical fitness status is 0-1 points;
- •According to RECIST version 1.1 standard, there must be at least one evaluable target lesion with a mass length diameter greater than 5cm;
- •Sign a written informed consent form before conducting any experimental activities;
- •Researchers determine that they are able to comply with the research protocol;
- •Patients who are willing and able to comply with visit arrangements, treatment plans, laboratory tests, and other research procedures.
排除标准
- •Local mass previously received radiation therapy;
- •Major surgery ≤ 4 weeks before enrollment;
- •Previous or concurrent malignant tumors (excluding malignant tumors that have been cured and have a cancer free survival of more than 5 years, such as basal cell carcinoma of the skin and papillary thyroid carcinoma);
- •Pregnant or lactating women;
- •Active pulmonary tuberculosis.
研究组 & 干预措施
brachytherapy
Patients with locally unresectable giant osteosarcoma masses who meet the criteria are enrolled in the experimental group, and all patients receive a single dose of 10Gy of implantable brachytherapy. Record treatment-related acute events during and after treatment. Follow up on survival and local control after treatment ends, marking the end of the trial treatment.
干预措施: brachytherapy (Radiation)
结局指标
主要结局
progression-free survival
时间窗: 6 months
6 months of progression-free survival
次要结局
- progression-free survival(12 months)
- OS(12 months)
- Adverse reactions related to radiotherapy(12 months)
研究者
Xiaojing Yang
Principal Investigator
Shanghai Jiao Tong University Affiliated Sixth People's Hospital