Proton Radiation For Meningiomas and Hemangiopericytomas
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.
Patients With a Diagnosis of WHO Grade I-III Meningioma and Hemangiopericytoma With Adequate Bone Marrow Function
Radiation: Proton Radiation
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Feasibility and Phase II Study Using Proton Radiation For WHO Grade I-III Meningiomas and Hemangiopericytomas|
- Feasibility and Safety [ Designated as safety issue: Yes ]For proton to deemed feasible, no greater than 10% of patients should experience a) Patient cannot be given treatment because anatomy is such that a dosimetically satisfactory treatment plan cannot be devised, b) Patient is unable to tolerate 20% of treatments using proton therapy, and c) patient is unable to complete all treatments within 7 days of estimated date of treatment completion
- Late Toxicity [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]Late toxicity is defined as any grade 3 or higher toxicity, excluding seizures, observed later than 90 days from start of radiation therapy.
- Fatigue - Brief Fatigue Inventory (BFI) [ Designated as safety issue: No ]Fatigue will be scored by the Brief Fatigue Inventory (BFI), a validated instrument, which will be evaluated at the following time points: Pre-radiation, weekly during treatment, at 3, 6, 9, 12 months post-radiation and then every 6 months. It is expected that BFI score will increase (as fatigue worsens) in the first 6-9 months post-radiation and then the BFI score will decrease (as fatigue improves) at 12-24 months post-radiation. Proton radiotherapy is expected to improve fatigue as compared to photon radiotherapy.
- Health Related Quality of Life [ Designated as safety issue: No ]Health Related Quality of Life will be followed using the following: EQ-5D European Quality of Life Index, Fact-G Functional Assessment of Cancer Therapy-General (FACT-G), and Fact-BR Functional Assessment of Cancer Therapy-Brain. Fact-BR will be evaluated at the same time points as the BFI. EQ-5D and Fact-G will be evaluated at pre-radiation, at 3, 6, 9, 12 months postradiation and then every 6 months.
- Cumulative total dose (Gy) to normal brain tissue [ Designated as safety issue: No ]Cumulative total dose (Gy) to normal brain tissue will be estimated based on dosimetry plans for both proton and photon. Proton radiotherapy is expected to decrease exposure to normal brain tissues.
- Progression free survival (PFS) and overall survival (OS) [ Designated as safety issue: No ]PFS and OS are defined as the time from start of radiotherapy to first documented progression (event for PFS), death due to any cause or last patient contact alive.
|Study Start Date:||February 2010|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Radiation: Proton Radiation
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01117844
|Contact: Robert Lustig, MD||855-216-0098||PennCancerTrials@emergingmed.com|
|United States, Pennsylvania|
|Abramson Cancer Center of the Unviersity of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Robert Lustig, MD 855-216-0098 PennCancerTrials@emergingmed.com|