A phase II single-arm trial of the treatment of patients with atypical meningiomas Simpson Grade 4 and 5 with a carbon ion boost in combination with post-operative photon radiotherapy

niversity Hospital of Heidelberg (Germany)0 个研究点目标入组 40 人开始时间: 2011年2月7日最近更新: 2019年5月5日

适应症

试验速览

•1. Histologically confirmed atypical meningioma
•2. Macroscopic tumour after biopsy or subtotal resection
•3. Simpson Grade 4 or 5
•4. Prior photon radiotherapy to the clinical target volume (CTV) of 48 - 52 Gy
•5. Beginning of study treatment no later than 12 weeks after surgery
•6. Aged greater than or equal to 18 years of age
•7. Karnofsky Performance Score greater than or equal to 60
•8. For women with childbearing potential, adequate contraception
•9. Ability of subject to understand character and individual consequences of the clinical trial
•10. Written informed consent (must be available before enrolment in the trial)

•1. Refusal of the patients to take part in the study
•2. Previous radiotherapy of the brain
•3. Optic nerve sheath meningioma (ONSM)
•4. Time interval of greater than 12 weeks after primary diagnosis (neurosurgical intervention) and beginning of study treatment
•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

发起方

niversity Hospital of Heidelberg (Germany)