ISRCTN01460925已完成不适用
Randomised phase I/II study to evaluate carbon ion radiotherapy versus fractionated stereotactic radiotherapy in patients with recurrent or progressive gliomas
niversity Hospital of Heidelberg (Germany)0 个研究点目标入组 436 人开始时间: 2011年2月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 436
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Unifocal, supratentorial recurrent glioma
- •2. Contrast enhancement on T1-weighted magnetic resonance imaging (MRI) and/or amino acid positron emission tomography (PET)-positive high-grade tumour areas
- •3. Indication re-irradiation
- •4. Aged greater than or equal to 18 years of age, either sex
- •5. Karnofsky Performance Score greater than or equal to 60
- •6. For women with childbearing potential, (and men) adequate contraception
- •7. Ability of subject to understand character and individual consequences of the clinical trial
- •8. Written informed consent (must be available before enrolment in the trial)
排除标准
- •1. Multifocal glioma or gliomatosis cerebri
- •2. Refusal of the patients to take part in the study
- •3. Previous re-irradiation or prior radiosurgery or prior treatment with interstitial radioactive seeds
- •4. Time interval of less than 6 months after primary radiotherapy
- •5. Patients who have not yet recovered from acute toxicities of prior therapies
- •6. Known carcinoma less than 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy
- •7. Pregnant or lactating women
- •8. Participation in another clinical study or observation period of competing trials, respectively
研究者
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