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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Skull Base Meningioma

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Trial Information

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

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity graded according to CTCAE Version 4.1 after 1 year

Outcome Description:

Toxicity graded according to CTCAE Version 4.1 after 1 year

Outcome Time Frame:

1 year

Safety Issue:

Yes

Authority:

Germany: Ethics Commission

Study ID:

PINOCCHIO

NCT ID:

NCT01795300

Start Date:

March 2013

Completion Date:

February 2016

Related Keywords:

  • Skull Base Meningioma
  • Meningioma

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