Carbon Ion Radiotherapy for Atypical Meningiomas

NCT01166321 | Active Not Recruiting DMC

• 2 other identifiers: MARCIE2009-016683-36
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Meningioma

Keywords

Atypical Meningioma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Progression-free survival at 3 years

Secondary Outcomes (1)

• Overall Survival

  Overall Survival at 3 years

Study Arms (1)

Carbon Ion Radiotherapy Boost

EXPERIMENTAL

Carbon Ion Boost to the Macroscopic Tumor visible on contrast-enhanced MR-Imaging

Radiation: Carbon Ion Radiotherapy

Interventions

Carbon Ion Radiotherapy RADIATION

Carbon Ion Boost 18 Gy E in single Fractions of 3 Gy E

Carbon Ion Radiotherapy Boost

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

University Hopsital Heidelberg

Heidelberg, 69120, Germany

Location

Related Publications (1)

• 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.

  PMID: 21062428 DERIVED

MeSH Terms

Conditions

Meningioma

Interventions

Heavy Ion Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Dr. Jürgen Debus

Study Record Dates

• First Submitted: July 20, 2010
• First Posted: July 21, 2010
• Study Start: June 1, 2012
• Primary Completion: July 1, 2020
• Study Completion: February 1, 2026
• Last Updated: January 5, 2024

Record last verified: 2024-01

Locations

DE (1)