NCT01117844

Proton Radiation For Meningiomas and Hemangiopericytomas

Feasibility and Phase II Study Using Proton Radiation For WHO Grade I-III Meningiomas and Hemangiopericytomas

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Feasibility/Phase II study for patients with a diagnosis of WHO Grade I - III Meningioma \& Hemangiopericytoma brain cancer to be given standard dose Proton radiotherapy. The study will be performed in two phases: first, feasibility with an enrollment of 12 patients and then Phase Page 8 of 20 II, with an enrollment of an additional 38 patients. All patients will also be given quality of life (QOL) instruments pretreatment, weekly during treatment, then q 3 months for year 1 post treatment, q6 months year 2 \& 3 and yearly for year 4 \& 5. Comparisons will be made between the enrolled subjects receiving proton therapy and the known literature on photon radiation. See section 2 for full objectives. The second phase will begin no earlier than 60 days after the last patient in the initial phase has completed treatment and once safety and feasibility has been verified. The secondary objectives will serve as the objectives for the second phase of the study.

Detailed description

Primary Objectives: The primary objectives of this study are feasibility and safety. The study will be deemed infeasible if greater than 10% of pts experience one of the following: * Patient cannot be given treatment because anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised. (95% of target volume covered by 95% of the dose) * Patient is unable to tolerate 20% of treatments (for any reason unable to set patient up within acceptable limits of tolerance, patient unable to tolerate treatment position or immobilization for duration of treatment) using proton radiotherapy (up to 80% of treatments could be delivered using photons). * Patient is unable to complete all of his/her treatments within 7 days of estimated date of treatment completion or requires a treatment break greater than 5 days. Toxicity will be deemed unacceptable if greater than 20% of patients experience acute toxicity, as defined in Section 7.12. Secondary Objectives: * To assess acute side effects from irradiation using proton beam therapy in place of conventional photon beam therapy for the treatment of meningiomas. * To assess quality of life outcomes, with a focus on the rate of severe fatigue at 6 and 12 months from end of treatment. * To assess late complications from irradiation using proton beam therapy in place of conventional photon beam therapy for the treatment of meningiomas. * To compare the dose distribution to tumor and surrounding normal structures using DVHs (Dose Volume Histograms) generated from the proton plan used to treat the patient and the photon plan generated for comparison purposes. * To determine 1-yr local control and progression-free and overall survival using proton radiotherapy.

Conditions

• Meningioma
• Hemangiopericytoma

Interventions

Type	Name	Description
RADIATION	Proton Radiation	Protons have been demonstrated for medulloblastoma and prostate cancer, and comparative treatment planning using protons versus photons have shown a clear advantage to protons in terms of dose distribution.

Timeline

• Start date: 2010-02-04
• Primary completion: 2023-03-31
• Completion: 2023-03-31
• First posted: 2010-05-06
• Last updated: 2024-11-07

Locations

1 site across 1 country: United States