Clinical Trial: Carbon Ion Radiotherapy for Atypical Meningiomas
Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional
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
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 Summary:
Sponsor: University Hospital Heidelberg
Current Primary Outcome: Progression-free survival [ Time Frame: Progression-free survival at 3 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Overall Survival [ Time Frame: Overall Survival at 3 years ]
Original Secondary Outcome: Same as current
Information By: University Hospital Heidelberg
Dates:
Date Received: July 20, 2010
Date Started: August 2010
Date Completion:
Last Updated: July 30, 2010
Last Verified: July 2010
