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临床试验/NCT00188175
NCT00188175已完成2 期

A Phase II Study of Preoperative Intensity-Modulated Radiation Therapy For Lower Limb Soft Tissue Sarcoma

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2003年5月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
59
试验地点
2
主要终点
Major wound complications within 120 days following surgery

研究概览

简要总结

Intensity-modulated radiation therapy may make wound healing problems less likely by 1)precisely shaping the region of high radiation dose to the shape of the tissue which harbours tumour cells, and 2) precisely shaping the regions of low radiation dose to the shapes of the normal tissues which are more sensitive to radiation effects.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Histologically proven soft tissue sarcoma
  • Lesion lies between the iliac crest (hipbone) and the ankle
  • Lesion is newly diagnosed
  • Assessed by radiation oncologist and surgical oncologist

排除标准

  • Benign histologies
  • Histologies generally treated with chemotherapy
  • Prior or recurrent cancer, except nonmelanomatous skin cancer or carcinoma in-situ of the cervix

研究组 & 干预措施

IMRT for lower limb soft tissue sarcoma

Experimental

干预措施: Intensity Modulated Radiation Therapy (Radiation)

结局指标

主要结局

Major wound complications within 120 days following surgery

时间窗: 120 days post-op

次要结局

  • Assess acute and late radiation toxicity including limb edema(up to120 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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