Clinical Trial: Proton Radiation For Meningiomas and Hemangiopericytomas

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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 Summary:

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
  Sponsor: Abramson Cancer Center of the University of Pennsylvania
  

  Current Primary Outcome: Feasibility and Safety

  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
  
  
  

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome:

  • Late Toxicity [ Time Frame: 90 days ]
    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)
    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
    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
    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)
    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.
  
  
  

  Original Secondary Outcome: Same as current
  
  Information By: Abramson Cancer Center of the University of Pennsylvania
  

  Dates:
  Date Received: April 28, 2010
  Date Started: February 2010
  Date Completion:
  Last Updated: September 23, 2016
  Last Verified: September 2016