A Phase II Trial of Proton RT for the Treatment of Pediatric Rhabdomyosarcoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 6
- 主要终点
- Cumulative Incidence (Estimated Percent of Participants) With Grade 3 or Higher Toxicity in Follow-up
研究概览
简要总结
The main purpose of this study is to see if using proton beam radiation therapy instead of photon beam radiation therapy can reduce side effects from radiation treatment for rhabdomyosarcoma. Photon beam radiation is the standard type of radiation for treating most rhabdomyosarcoma and many other types of cancer. Photon beam radiation enters the body and passes through healthy tissue, encounters the tumor, then leaves the body through healthy tissue. A beam of proton radiation enters the body and passes through healthy tissue, encounters tumor, but then stops. This means that less healthy tissue is affected by proton beam radiation than by photon beam radiation.
详细描述
- A special device is made for each participant to help them hold still during the treatment. This may be in the form of a mask or a custom made foam cradle depending on the area to be treated.
- Radiation treatments will be given once per day, 5 days a week for a total of 4 to 6 weeks, depending upon how much total dose the tumor requires.
- Participants will be seen once per week by their radiation doctor to monitor health and record any side effects from treatment.
- After the radiation treatments are completed, participants will be required to undergo further tests and evaluations for several years following treatment.
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 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with biopsy proven newly diagnosed rhabdomyosarcoma.
- •Patients less than or equal to 30 years of age.
- •Patients must be treated with a standardly accepted chemotherapy regimen.
- •May not have metastatic disease unless aged 2-10 with embryonal histology.
- •Must be willing to receive follow-up care for a minimum of five years after treatment at MGH and annual visits unless it is too difficult to return to MGH for follow-up care. In that event, they must be willing to have their outside medical information released to us to track the results.
- •Timing of radiation must be according to the IRB protocol upon which the patient is treated within either 35 days of last chemotherapy or surgery.
排除标准
- •Life expectancy of less than 2 years.
- •Co-morbidities that would make the use of radiation too toxic to deliver safely, such as serious local injury or collagen vascular disease.
- •Patients who are pregnant
- •Previous treatment with radiation therapy.
结局指标
主要结局
Cumulative Incidence (Estimated Percent of Participants) With Grade 3 or Higher Toxicity in Follow-up
时间窗: 5 years from the start of radiation treatment
Cumulative incidence of participants who experienced a toxicity defined as either grade 3, 4, or 5 after the completion of radiation therapy in pediatric patients with pediatric rhabdomyosarcomas. Late toxicity is scored on a yearly follow-up basis for at least five years. Late toxicities will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. Cumulative incidence is shown at 5 years follow-up.
次要结局
- Percentage of Participants Who Experienced an Acute Toxicity by Grade(3 months from radiation treatment)
- Dosimetric Comparison(4 years from the start of radiation treatment)
- Local Control(5 years from the start of radiation therapy)
研究者
Torunn Yock, MD
Director, Pediatric Radiation Oncology
Massachusetts General Hospital