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Treatment of Patients With Atypical Meningiomas Simpson Grade 4 and 5 With a Carbon Ion Boost in Combination With Postoperative Photon Radiotherapy: A Phase II Trial


Phase 2
18 Years
N/A
Not Enrolling
Both
Meningioma

Thank you

Trial Information

Treatment of Patients With Atypical Meningiomas Simpson Grade 4 and 5 With a Carbon Ion Boost in Combination With Postoperative Photon Radiotherapy: A Phase II Trial


Inclusion Criteria:



- histologically confirmed atypical meningioma

- macroscopic tumor after biopsy or subtotal resection

- Simpson Grade 4 or 5

- prior photon radiotherapy to the clinical target volume (CTV) of 48-52 Gy

- beginning of study treatment no later than 12 weeks after surgery

- age ≥ 18 years of age

- Karnofsky Performance Score ≥ 60

- For women with childbearing potential, adequate contraception

- 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:

- refusal of the patients to take part in the study

- previous radiotherapy of the brain

- optic nerve sheath meningioma (ONSM)

- time interval of > 12 weeks after primary diagnosis (neurosurgical intervention) and
beginning of study treatment

- 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: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

Progression-free survival at 3 years

Safety Issue:

No

Authority:

Germany: Federal Office for Radiation Protection

Study ID:

MARCIE

NCT ID:

NCT01166321

Start Date:

August 2010

Completion Date:

Related Keywords:

  • Meningioma
  • Atypical Meningioma
  • Meningioma

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