Comparison of Proton and Carbon Ion Radiotherapy With Advanced Photon Radiotherapy in Skull Base Meningiomas: The PINOCCHIO Trial.
- Conditions
- Skull Base Meningioma
- Registration Number
- NCT01795300
- Lead Sponsor
- University Hospital Heidelberg
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Toxicity graded according to CTCAE Version 4.1 after 1 year 1 year Toxicity graded according to CTCAE Version 4.1 after 1 year
- Secondary Outcome Measures
Name Time Method Quality of Life 3 years Progression-free survival 3 years Progression-free survival
Overall survival 3 years Overall survival
Trial Locations
- Locations (1)
University Hospital of Heidelberg, Radiation Oncology
🇩🇪Heidelberg, Germany
University Hospital of Heidelberg, Radiation Oncology🇩🇪Heidelberg, Germany