Proton Radiation for Low Grade Gliomas
PRIMARY OBJECTIVES:
I. To evaluate the feasibility of proton beam radiation therapy in patients with low grade
gliomas. (Phase I)
SECONDARY OBJECTIVES:
I. To assess late complications from irradiation using proton beam therapy in place of
conventional photon beam therapy for the treatment of low grade gliomas. (Phase II) II. To
assess acute side effects from irradiation using proton beam therapy in place of
conventional photon beam therapy for the treatment of low grade gliomas. (Phase II) III. To
compare the dose distribution to tumor and surrounding normal structures using DVH's (Dose
Volume Histograms) generated from the proton plan used to treat the patient and the photon
plan generated for comparison purposes. (Phase II) IV. To monitor the rates of local
control, overall and disease specific survival using proton radiotherapy. (Phase II) V. To
evaluate the time to progression of low grade gliomas treated with protons. (Phase II) VI.
To evaluate the incidence and severity of fatigue in low grade glioma treated with protons.
(Phase II) VII. To evaluate the effect of proton beam radiation on neurocognitive outcome in
patients with low grade glioma. (Phase II) VIII. To evaluate the quality of life in patients
treated for low grade glioma. (Phase II)
OUTLINE: Patients undergo proton beam radiation therapy for 6 weeks in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 5 years.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility (phase I)
No
Robert Lustig
Principal Investigator
Abramson Cancer Center of the University of Pennsylvania
United States: Institutional Review Board
UPCC 08309
NCT01024907
July 2009
Name | Location |
---|---|
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |