NCT00592345已完成1 期
High-Dose Proton/Photon RT + Surgery of Sarcomas of the Thoracic, Lumbar Spine/Sacrum
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- To define the efficacy of high dose fractionated radiation alone or combined with surgery in this patient population.
研究概览
简要总结
The purpose of this study is to test the effectiveness of high dose radiation administered by both proton and photon therapy. Radiation is an effective treatment for many types of tumors and it is thought that radiation alone, when given in much higher doses over a shorter period of time, may be more effective in controlling recurrence of sarcoma.
详细描述
- In this study three types of radiation will be used: standard radiation (called photon); alternative form of radiation called proton beam therapy; and a localized radiation applicator plaque that can be applied to the surface of the dura (the fibrous outer envelope that surrounds the spinal cord and fluid surrounding the spinal cord) at time of surgical removal of the tumor.
- Radiation treatments (photon and proton) and possibly surgical removal of portions of the tumor with intraoperative radiation delivery to the surface dura with intraoperative radiation delivery will be performed over a period of 12 weeks. As part of the treatment planning process, participants will need two treatment planning CT scans and 2-3 treatment planning sessions.
- Participants will receive, in total, 39-43 photon/proton treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathological diagnosis of malignant mesenchymal tumor of the thoracic/lumbar/spine/sacrum or paraspinal soft tissues involving nerve roots or extending into spinal canal. Inter-osseous bone sarcomas are to be managed by wide resectional surgery for patients that are medically operable.
- •Patient tumor status: 1) post biopsy or post resection with gross residual disease 2) post grossly complete resection but with margins positive or very close or tumor spill or cut through
- •Lesion may be primary or recurrent after prior surgery
- •No clinical, radiographic or other evidence of distant metastasis
- •Fit for the exposure of the affected vertebral segment
- •Life expectancy of greater than 36 months
- •KPS equal to or greater than 70
- •18 years of age or older
- •Declines radical surgery
- •No prior radiation treatment to the affected spine region
排除标准
- •Pregnancy
- •Disease/conditions characterized by high radiation sensitivity. These include genetic diseases, such as ataxia telangiectasia. Major local conditions which are the local tolerance viz., multiple surgical procedures, serious local injuries.
- •No evident cord/cauda malfunction for causes other than effects of local tumor growth or due to metabolic effects of tumor
结局指标
主要结局
To define the efficacy of high dose fractionated radiation alone or combined with surgery in this patient population.
时间窗: 3 years
次要结局
- To evaluate the acute and later tolerance in 50 patients of high dose proton/photon radiation treatment.(3 years)
研究者
Tom DeLaney, MD
Attending Radiation Oncologist
Massachusetts General Hospital
研究点 (2)
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