Clinical trial NCT01166321: Carbon Ion Radiotherapy for Atypical Meningiomas
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Meningioma
Keywords: Atypical Meningioma
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2010-07-21
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival
timeFrame: Progression-free survival at 3 years
Secondary outcomes:
measure: Overall Survival
timeFrame: Overall Survival at 3 years
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hopsital Heidelberg
Study officials:
References:
citation: Combs SE, Edler L, Burkholder I, Rieken S, Habermehl D, Jakel O, Haberer T, Unterberg A, Wick W, Debus J, Haselmann R. Treatment of patients with atypical meningiomas Simpson grade 4 and 5 with a carbon ion boost in combination with postoperative photon radiotherapy: the MARCIE trial. BMC Cancer. 2010 Nov 9;10:615. doi: 10.1186/1471-2407-10-615.