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临床试验/NCT00850200
NCT00850200已完成不适用

Improving the Therapeutic Ratio by Using Proton Beam Radiation Therapy for Patients With Stage IA-IIIBX (Bulky/Non-bulky) Hodgkin Lymphoma Involving the Mediastinum Following Standard Chemotherapy

University of Florida1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2009年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Comparison of Normal Tissue Exposed to Greater Than or Equal to 4 Gy/CGE With Use of Proton Therapy Compared to Both Intensity Modulated Radiotherapy (IMRT) and Conventional Therapy.

研究概览

简要总结

The purpose of this study is to reduce the risk of radiation related side effects and complications by treating with radiation (protons or photons) that exposes less of normal organs to low dose radiation.

详细描述

3 treatment plans will be created to deliver between a total of 21-39.6 Gray (Gy)/Centigray Equivalents (CGE) to the planning target volume (PTV).

  1. Proton Plan
  2. Conventional Plan
  3. Intensity Modulated Radiotherapy (IMRT) Plan

The patient will then receive the radiation modality with the lowest percentage of the body receiving 4 Gy (V4Gy/CGE)

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
6 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Confirmed "classic" Hodgkin lymphoma.
  • •Completed chemotherapy.

排除标准

  • •Prior radiotherapy.
  • •Prior or concurrent cancer other than non-melanomatous skin cancer.

研究组 & 干预措施

Proton Radiation Plan

Experimental

干预措施: Proton Radiation Plan (Radiation)

Conventional Photon Radiation Plan

Active Comparator

干预措施: Conventional Photon Radiation Plan (Radiation)

Intensity Modulated Radiation Plan

Active Comparator

干预措施: Intensity Modulated Radiation Plan (Radiation)

结局指标

主要结局

Comparison of Normal Tissue Exposed to Greater Than or Equal to 4 Gy/CGE With Use of Proton Therapy Compared to Both Intensity Modulated Radiotherapy (IMRT) and Conventional Therapy.

时间窗: Immediately proceeding completion of each of the three treatment plans

次要结局

  • Percentage of Participants Who Survived(4 years after beginning of radiation therapy)
  • Percentage of Participants Who Did Not Have Disease Progression(4 years after beginning of radiation therapy)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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