We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01166321
Recruitment Status : Unknown
Verified July 2010 by University Hospital Heidelberg.
Recruitment status was:  Not yet recruiting
First Posted : July 21, 2010
Last Update Posted : August 2, 2010
Sponsor:
Information provided by:

Study Description
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 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
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
Study Start Date : August 2010
Estimated Primary Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 ( EudraCT Number )
First Posted: July 21, 2010    Key Record Dates
Last Update Posted: August 2, 2010
Last Verified: July 2010

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