Whole Lung IMRT in Children and Adults With Synovial Sarcoma and Lung Metastases
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 9
- 主要终点
- Number of Participants Evaluated for Toxicity
研究概览
简要总结
The purpose of this study is to find out what effects, good and/or bad, radiation has on the lungs has on the patient and on synovial sarcoma which has spread to the lungs. The standard treatment for synovial sarcoma which has spread to the lungs is chemotherapy with or without surgery to remove the tumors in the lungs. However, tumors often come back in the lungs after chemotherapy and/or surgery. Since synovial sarcoma is known to be sensitive to radiation, this study is looking at whether radiation therapy which is targeted to the entire lung can further reduce the chances of the cancer returning. This type of radiation is commonly used in other types of sarcoma to treat the cancer once it has spread to the lungs and it may be very useful in synovial sarcoma as well.
In this study, a special type of radiation will be used, called Intensity Modulated Radiation Therapy (IMRT). With IMRT the radiation beams are more customized to focus more radiation on the tumor cells while delivering less radiation to areas like the heart. The goal of this study is also to measure pulmonary toxicity and see if IMRT is feasible and has less toxicity.
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
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with synovial sarcoma confirmed by MSKCC pathological review
- •Patients with single or multiple lung metastases at diagnosis or that develop over the course of treatment. After completion of all chemotherapy, lung metastases or must be ≤ 2cm.
- •Age ≥12 months of age
- •Karnofsky performance status (KPS) must be ≥ 70 for patients ≥ 16 years of age and Lansky performance status must be ≥ 70 for patients < 16 years of age.
- •Normal cardiac function
- •No active coronary artery disease;
- •No New York Heart Association class II, III or IV disease;
- •No arrhythmia requiring treatment.
- •Baseline echocardiogram with a shortening fraction of ≥27% or an ejection fraction ≥ 50%.
- •Female patients of childbearing potential must have a negative pregnancy test within 14 days of radiation start.
- •Female patients who are lactating must agree to stop breast-feeding.
- •Sexually active patients of childbearing potential must agree to use effective contraception.
排除标准
- •Patients with a history of prior radiation therapy to the thorax.
- •Patients requiring a field size >40 cm as IMRT cannot be performed at extended SSDs.
- •Patients with any concurrent medical or psychiatric condition or disease which, in the investigator's judgment, would make them inappropriate candidates for entry into this study.
结局指标
主要结局
Number of Participants Evaluated for Toxicity
时间窗: within 3 months of the completion of treatment or 3 months following the completion of treatment.
The CTCAE version 4.0 scale will be used. The radiation oncologist will score toxicity at each visit.
次要结局
- Pulmonary Failure-free Survival(pre-treatment, 3 and 6 months (+/- 3 weeks) and at 12, 18, and 24 months (+/- 6 weeks) post-treatment)
- Rates of Overall Survival (OS)(two-year follow-up)