Clinical trial NCT01117844: Proton Radiation For Meningiomas and Hemangiopericytomas
Official title: Feasibility and Phase II Study Using Proton Radiation For WHO Grade I-III Meningiomas and Hemangiopericytomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Meningioma
Hemangiopericytoma
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2010-05-06
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of WHO I-III meningiomas and hemangiopericytomas:

  1. WHO grade I :

     * Tumor that are newly diagnosed and tumors that are incompletely excised
     * Tumors that have recurred post resection
  2. WHO grade II:

     * Any tumor, either completely or incompletely excised
     * Any recurrent tumor
  3. WHO grade III and hemangiopericytoma:

     * Any tumor, either completely or incompletely excised
     * Any recurrent tumor
* Patients must have a Karnofsky Performance Status of 60. Age greater than 18 years Patients must be able to provide informed consent.
* Adequate bone marrow function: WBC greater than 4000/mm3, platelets greater than 100,000 mm3.
* Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc.). Hysterectomy or menopause must be clinically documented.

Exclusion Criteria:

* Prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma).
* Pregnant women, women planning to become pregnant and women that are nursing. Actively being treated on any other therapeutic research study.
* Prior radiation to the brain.

Primary outcomes:
measure: Feasibility and Safety
timeFrame: 90 days
Secondary outcomes:
measure: Late Toxicity
timeFrame: 90 days
measure: Fatigue - Brief Fatigue Inventory (BFI)
timeFrame: 5 Years
measure: Health Related Quality of Life
timeFrame: 5 Years
measure: Cumulative total dose (Gy) to normal brain tissue
timeFrame: 8 Weeks
measure: Progression free survival (PFS) and overall survival (OS)
timeFrame: 5 Years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the Unviersity of Pennsylvania
state: Pennsylvania
Study officials:
References: