Comparison of Proton and Carbon Ion Radiotherapy With Advanced Photon Radiotherapy in Skull Base Meningiomas: The PINOCCHIO Trial.

Not Applicable

Withdrawn

• Conditions: Skull Base Meningioma
• Interventions: Radiation: Carbon Ion Radiotherapy; Radiation: Hypofractionated Photon Radiotherapy; Radiation: Conventional Photon Radiotherapy; Radiation: Proton Therapy

• 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

Study Timeline

• Study First Submitted: 2013-02-18
• Study First Submitted QC: 2013-02-18
• Study First Posted: 2013-02-20
• Study Start: 2020-05-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-10-06
• Primary Completion: 2022-05
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carbon Ion Radiotherapy	Carbon Ion Radiotherapy	Treatment Schedule Carbon Ion Radiation Total Dose 45 Gy E, 15 fractions, 3 Gy E single dose
Hypofractionated Photon Therapy	Hypofractionated Photon Radiotherapy	Treatment Schedule Photon Radiation 3 Gy E Total Dose 45 Gy E, 15 fractions, 3 Gy E single dose
Conventional Photon Radiotherapy	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
Proton Therapy	Proton Therapy	Treatment Schedule Proton Radiation Total Dose 45 Gy E, 15 fractions, 3 Gy E single dose

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
Progression-free survival	3 years	Progression-free survival
Overall survival	3 years	Overall survival
Quality of Life	3 years

Trial Locations

Locations (1)

University Hospital of Heidelberg, Radiation Oncology; 🇩🇪 Heidelberg, Germany