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Carbon Ion Radiotherapy for Atypical Meningiomas (MARCIE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01166321
Recruitment Status : Recruiting
First Posted : July 21, 2010
Last Update Posted : June 22, 2021
Information provided by (Responsible Party):
Juergen Debus, University Hospital Heidelberg

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.

Condition or disease Intervention/treatment Phase
Meningioma Radiation: Carbon Ion Radiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : June 2012
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: Progression-free survival at 3 years ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Overall Survival at 3 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01166321

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Contact: Jürgen Debus, MD PhD +49-6221-56- ext 8201

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University Hopsital Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Jürgen Debus, MD PhD    +49 6221 56 ext 34093   
Sponsors and Collaborators
University Hospital Heidelberg
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Juergen Debus, Prof. Dr. Dr. Jürgen Debus, University Hospital Heidelberg Identifier: NCT01166321    
Other Study ID Numbers: MARCIE
2009-016683-36 ( EudraCT Number )
First Posted: July 21, 2010    Key Record Dates
Last Update Posted: June 22, 2021
Last Verified: June 2021
Keywords provided by Juergen Debus, University Hospital Heidelberg:
Atypical Meningioma
Additional relevant MeSH terms:
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Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases