Proton Beam Radiation Therapy in Treating Patients With Low Grade Gliomas

Phase 1

Completed

Conditions: Adult Brain Stem Glioma
Adult Oligodendroglioma
Adult Pineal Gland Astrocytoma
Adult Grade II Meningioma
Adult Diffuse Astrocytoma
Adult Pineocytoma
Adult Brain Tumor
Adult Ependymoma
Adult Melanocytic Lesion
Adult Meningeal Hemangiopericytoma

Interventions: Radiation: proton beam radiation therapy
Procedure: quality-of-life assessment
Other: questionnaire administration

Registration Number: NCT01024907

Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 23

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I	questionnaire administration	Patients undergo proton beam radiation therapy for 6 weeks in the absence of disease progression or unacceptable toxicity.
Arm I	proton beam radiation therapy	Patients undergo proton beam radiation therapy for 6 weeks in the absence of disease progression or unacceptable toxicity.
Arm I	quality-of-life assessment	Patients undergo proton beam radiation therapy for 6 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Acute toxicity as assessed by NCI CTC version 3.0 (phases I and II)	60 days (phase I) or 90 days (phase II) from completion of radiation therapy
Feasibility (phase I)

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (phases I and II)
Adverse events as assessed by NCI CTCAE version 3.0
Cumulative total dose to normal brain tissue (phase II)
Late toxicity as graded according to the RTOG/EORTC late morbidity scoring system (phases I and II)
Fatigue as assessed by the Brief Fatigue Inventory (phases I and II)	Pre-radiation, mid-treatment, and post-radiation; at 3, 6, 9, and 12 months post-radiation; and then every 6 months
Overall survival (phases I and II)