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

Trial Information

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

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.