Carbon Ion Radiotherapy for Atypical Meningiomas - Full Text View

Sponsor:	University Hospital Heidelberg
Information provided by:	University Hospital Heidelberg
ClinicalTrials.gov Identifier:	NCT01166321

Purpose

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.

Condition	Intervention	Phase
Meningioma	Radiation: Carbon Ion Radiotherapy	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by University Hospital Heidelberg:

Primary Outcome Measures:

Progression-free survival [ Time Frame: Progression-free survival at 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall Survival [ Time Frame: Overall Survival at 3 years ]

Estimated Enrollment:	40
Study Start Date:	August 2010
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Carbon Ion Radiotherapy Boost Carbon Ion Boost to the Macroscopic Tumor visible on contrast-enhanced MR-Imaging	Radiation: Carbon Ion Radiotherapy Carbon Ion Boost 18 Gy E in single Fractions of 3 Gy E

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01166321

Contacts

Contact: Jürgen Debus, MD PhD	+49-6221-56- ext 8201	juergen.debus@med.uni-heidelberg.de
Contact: Stephanie E Combs, MD	+49-6221-56- ext 8202	stephanie.combs@med.uni-heidelberg.de

Locations

Germany
University Hospital of Heidelberg, Radiation Oncology
Heidelberg, Germany, 69120

Sponsors and Collaborators

University Hospital Heidelberg

More Information

No publications provided by University Hospital Heidelberg

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Combs SE, Edler L, Burkholder I, Rieken S, Habermehl D, Jäkel 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.

Responsible Party:	Prof. Dr. Dr. Jürgen Debus, Department of Radiation Oncology, University Hospital of Heidelberg
ClinicalTrials.gov Identifier:	NCT01166321 History of Changes
Other Study ID Numbers:	MARCIE, 2009-016683-36
Study First Received:	July 20, 2010
Last Updated:	July 30, 2010
Health Authority:	Germany: Federal Office for Radiation Protection

Keywords provided by University Hospital Heidelberg:

Atypical Meningioma

Additional relevant MeSH terms:

Meningioma
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue

Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2012