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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.
 
ClinicalTrials.gov Identifier: NCT01166321
Recruitment Status : Recruiting
First Posted : July 21, 2010
Last Update Posted : June 22, 2021
Sponsor:
Information provided by (Responsible Party):
Juergen Debus, University Hospital Heidelberg

Tracking Information
First Submitted Date  ICMJE July 20, 2010
First Posted Date  ICMJE July 21, 2010
Last Update Posted Date June 22, 2021
Actual Study Start Date  ICMJE June 2012
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2010)
Progression-free survival [ Time Frame: Progression-free survival at 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2010)
Overall Survival [ Time Frame: Overall Survival at 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Carbon Ion Radiotherapy for Atypical Meningiomas
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Meningioma
Intervention  ICMJE Radiation: Carbon Ion Radiotherapy
Carbon Ion Boost 18 Gy E in single Fractions of 3 Gy E
Study Arms  ICMJE Experimental: Carbon Ion Radiotherapy Boost
Carbon Ion Boost to the Macroscopic Tumor visible on contrast-enhanced MR-Imaging
Intervention: Radiation: Carbon Ion Radiotherapy
Publications * 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. doi: 10.1186/1471-2407-10-615.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 20, 2010)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2023
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jürgen Debus, MD PhD +49-6221-56- ext 8201 juergen.debus@med.uni-heidelberg.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01166321
Other Study ID Numbers  ICMJE MARCIE
2009-016683-36 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Juergen Debus, University Hospital Heidelberg
Study Sponsor  ICMJE University Hospital Heidelberg
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital Heidelberg
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP