Randomized Comparison of Proton and Carbon Ion Radiotherapy With Advanced Photon Radiotherapy in Skull Base Meningiomas: The PINOCCHIO Trial.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Toxicity graded according to CTCAE Version 4.1 after 1 year
研究概览
简要总结
In PINOCCHIO-Triayl, carbon ion radiotherapy is compared to proton and advanced photon radiotherapy in patients with skull base meningiomas. There will be two treatment arms with photons, one arm with hypofractionated photon radiotherapy, and one arm with conventional fractionation. The study is designed as descriptive study on feasibility of the investigated therapies aiming at a comparison of toxicities. The study will serve as a basis for further larger randomized protocols comparing efficacy of the therapies, assuming toxicity is comparable in all four treatment arms. Primary endpoint is toxicity, secondary endpoints are overall survival, progression-free survival and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients meeting all of the following criteria will be considered for admission to the trial:
- •Histologically or imaging confirmed skull base meningioma
- •macroscopic tumor - Simpson Grade 4 or 5
- •age ≥ 18 years of age
- •Karnofsky Performance Score >=60
- •For women with childbearing potential, (and men) adequate contraception (sexual abstinence, estrogen- or gestagen containing contraceptive medication etc.)
- •Female participants: No pregnancy present (pregnancy test required)
- •Ability of subject to understand character and individual consequences of the clinical trial
- •Written informed consent (must be available before enrolment in the trial)
排除标准
- •Patients presenting with any of the following criteria will not be included in the trial:
- •refusal of the patients to take part in the study
- •previous radiotherapy of the brain
- •histologically confirmed atypical or anaplastic meningioma
- •optic nerve sheath meningioma (ONSM)
- •Patients who have not yet recovered from acute toxicities of prior therapies
- •Known carcinoma < 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
- •Pregnant or lactating women
- •Participation in another clinical study or observation period of competing trials, respectively.
研究组 & 干预措施
Carbon Ion Radiotherapy
Treatment Schedule Carbon Ion Radiation Total Dose 45 Gy E, 15 fractions, 3 Gy E single dose
干预措施: Carbon Ion Radiotherapy (Radiation)
Proton Therapy
Treatment Schedule Proton Radiation Total Dose 45 Gy E, 15 fractions, 3 Gy E single dose
干预措施: Proton Therapy (Radiation)
Hypofractionated Photon Therapy
Treatment Schedule Photon Radiation 3 Gy E Total Dose 45 Gy E, 15 fractions, 3 Gy E single dose
干预措施: Hypofractionated Photon Radiotherapy (Radiation)
Conventional Photon Radiotherapy
Treatment Schedule Photon Radiation 1.8 Gy E Total Dose 57.6 Gy Gy E, 32 fractions, 1.8 Gy E single dose
干预措施: Conventional Photon Radiotherapy (Radiation)
结局指标
主要结局
Toxicity graded according to CTCAE Version 4.1 after 1 year
时间窗: 1 year
Toxicity graded according to CTCAE Version 4.1 after 1 year
次要结局
- Progression-free survival(3 years)
- Overall survival(3 years)
- Quality of Life(3 years)
研究者
Juergen Debus
Prof. Dr. Dr. Jürgen Debus
University Hospital Heidelberg