Carbon Ion Radiotherapy for Atypical Meningiomas (MARCIE)

  • STATUS
    Recruiting
  • End date
    Aug 29, 2023
  • participants needed
    40
  • sponsor
    University Hospital Heidelberg
Updated on 3 March 2022
malignant meningioma
atypical meningioma

Summary

Treatment standard for patients with atypical or anaplastic meningioma is neurosurgical resection. With this approach, local control ranges between 50 and 70%, depending on resection status. A series or smaller studies has shown that postoperative radiotherapy in this patient population can increase progression-free survival, which translates into increased overall survival. However, meningiomas are known to be radioresistant tumors, and radiation doses of 60 Gy or higher have been shown to be necessary for tumor control.

Carbon ions offer physical and biological characteristics. Due to their inverted dose profile and the high local dose deposition within the Bragg peak precise dose application and sparing of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an increased relative biological effectiveness (RBE), which can be calculated between 2 and 5 depending on the cell line as well as the endpoint analyzed.

First data obtained within the Phase I/II trial performed at GSI in Darmstadt on carbon ion radiotherapy for patients with high-risk meningiomas has shown safety, and treatment results are promising.

Therefore, in the current Phase II-MARCIE-Study a carbon ion boost will be applied to the macroscopic tumor (gross tumor volume, GTV) in conjunction with photon radiotherapy to the clinical target volume (CTV) in patients with atypical meningiomas after incomplete resection or biopsy.

Primary endpoint is progression-free survival rate, secondary endpoints are overall survival, safety and toxicity.

Details
Condition Meningioma
Treatment Carbon Ion Radiotherapy
Clinical Study IdentifierNCT01166321
SponsorUniversity Hospital Heidelberg
Last Modified on3 March 2022

Eligibility

Yes No Not Sure

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
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