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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Patients With a Diagnosis of WHO Grade I-III Meningioma and Hemangiopericytoma With Adequate Bone Marrow Function

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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.


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.

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Feasibility and Safety

Outcome Description:

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

Safety Issue:

Yes

Authority:

United States: Institutional Review Board

Study ID:

UPCC 24309

NCT ID:

NCT01117844

Start Date:

February 2010

Completion Date:

Related Keywords:

  • Patients With a Diagnosis of WHO Grade I-III Meningioma and Hemangiopericytoma With Adequate Bone Marrow Function
  • Hemangiopericytoma
  • Meningioma

Name

Location

Abramson Cancer Center of the Unviersity of PennsylvaniaPhiladelphia, Pennsylvania  19104