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

University Hospital Heidelberg

Status: Withdrawn

Conditions: Skull Base Meningioma

Treatments: Radiation: Proton Therapy; Radiation: Carbon Ion Radiotherapy; Radiation: Hypofractionated Photon Radiotherapy; Radiation: Conventional Photon Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01795300

PINOCCHIO

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

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)

Exclusion criteria:

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 4 patient groups

Carbon Ion Radiotherapy

Experimental group

Description:

Treatment Schedule Carbon Ion Radiation Total Dose 45 Gy E, 15 fractions, 3 Gy E single dose

Treatment:

Radiation: Carbon Ion Radiotherapy

Proton Therapy

Experimental group

Description:

Treatment Schedule Proton Radiation Total Dose 45 Gy E, 15 fractions, 3 Gy E single dose

Treatment:

Radiation: Proton Therapy

Hypofractionated Photon Therapy

Experimental group

Description:

Treatment Schedule Photon Radiation 3 Gy E Total Dose 45 Gy E, 15 fractions, 3 Gy E single dose

Treatment:

Radiation: Hypofractionated Photon Radiotherapy

Conventional Photon Radiotherapy

Active Comparator group

Description:

Treatment Schedule Photon Radiation 1.8 Gy E Total Dose 57.6 Gy Gy E, 32 fractions, 1.8 Gy E single dose

Treatment:

Radiation: Conventional Photon Radiotherapy