NCT01024907

Proton Beam Radiation Therapy in Treating Patients With Low Grade Gliomas

Proton Radiation for Low Grade Gliomas

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Specialized radiation therapy, such as proton beam radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This phase I/II trial is studying the best way to give proton beam radiation therapy and to see how well it works in treating patients with low grade gliomas.

Detailed description

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.

Conditions

• Adult Brain Tumor
• Adult Brain Stem Glioma
• Adult Diffuse Astrocytoma
• Adult Ependymoma
• Adult Grade II Meningioma
• Adult Melanocytic Lesion
• Adult Meningeal Hemangiopericytoma
• Adult Mixed Glioma
• Adult Oligodendroglioma
• Adult Pineal Gland Astrocytoma
• Adult Pineocytoma
• Recurrent Adult Brain Tumor

Interventions

Type	Name	Description
RADIATION	proton beam radiation therapy	Undergo radiation
PROCEDURE	quality-of-life assessment	Ancillary study
OTHER	questionnaire administration	Ancillary study

Timeline

• Start date: 2009-12-17
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2009-12-03
• Last updated: 2020-12-10

Locations

1 site across 1 country: United States