ISRCTN37428883已完成2 期
Randomised phase II study evaluating a carbon ion boost applied after combined radiochemotherapy with temozolomide versus a proton boost after radiochemotherapy with temozolomide in patients with primary glioblastoma
niversity Hospital of Heidelberg (Germany)0 个研究点目标入组 150 人开始时间: 2010年7月8日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
研究概览
简要总结
2010 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/20819220 results
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Histologically confirmed unifocal, supratentorial primary glioblastoma
- •2. Macroscopic tumour after biopsy or subtotal resection
- •3. Indication for combined radiochemotherapy with temozolomide
- •4. Prior photon irradiation of 50 Gy to the T2-hyperintense area, resection cavity, areas of contrast enhancement adding 2 - 3 cm safety margin
- •5. Registration prior to photon RT or within photon RT allowing the beginning of C12 greater than or equal to 4 days after completion of photon irradiation
- •6. Beginning of study treatment (proton or carbon ion RT) no later than 10 weeks after primary diagnosis
- •7. Aged greater than or equal to 18 years, either sex
- •8. Karnofsky Performance Score less than or equal to 60
- •9. Life expectancy greater than 12 weeks
- •10. For women with childbearing potential, (and men) adequate contraception
- •11. Ability of subject to understand character and individual consequences of the clinical trial
- •12. Written informed consent (must be available before enrolment in the trial)
排除标准
- •1. Refusal of the patients to take part in the study
- •2. Previous radiotherapy of the brain or chemotherapy with dacarbazine (DTIC) or TMZ
- •3. More than 50.4 Gy applied via photon-RT prior to carbon ion RT
- •4. Time interval of greater than 10 weeks after primary diagnosis and beginning of study treatment (proton or carbon ion RT)
- •5. Patients who have not yet recovered from acute toxicities of prior therapies
- •6. Clinically active kidney-liver or cardiac disease
- •7. 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
- •8. Human immunodeficiency virus (HIV)
- •9. Pregnant or lactating women
- •10. Participation in another clinical study or observation period of competing trials, respectively
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