Proton Beam Radiation Therapy in Treating Patients With Low Grade Gliomas

Sponsor

Abramson Cancer Center of the University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT01024907

Collaborator

(none)

Enrollment

Location

Arm

49.5

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Radiation: proton beam radiation therapy Procedure: quality-of-life assessment Other: questionnaire administration	Phase 1/Phase 2

Detailed Description

PRIMARY OBJECTIVES:

To evaluate the feasibility of proton beam radiation therapy in patients with low grade gliomas. (Phase I)

SECONDARY OBJECTIVES:

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)
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.

Study Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Proton Radiation for Low Grade Gliomas

Actual Study Start Date :

Dec 17, 2009

Actual Primary Completion Date :

Feb 1, 2014

Actual Study Completion Date :

Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I Patients undergo proton beam radiation therapy for 6 weeks in the absence of disease progression or unacceptable toxicity.	Radiation: proton beam radiation therapy Undergo radiation Procedure: quality-of-life assessment Ancillary study Other: questionnaire administration Ancillary study

Arm

Intervention/Treatment

Experimental: Arm I

Patients undergo proton beam radiation therapy for 6 weeks in the absence of disease progression or unacceptable toxicity.

Radiation: proton beam radiation therapy

Undergo radiation

Procedure: quality-of-life assessment

Ancillary study

Other: questionnaire administration

Ancillary study

Outcome Measures

Primary Outcome Measures

Feasibility (phase I) []
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]

Secondary Outcome Measures

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]
Cumulative total dose to normal brain tissue (phase II) []
Progression-free survival (phases I and II) []
Overall survival (phases I and II) []
Adverse events as assessed by NCI CTCAE version 3.0 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion

Patients with histologically confirmed diagnosis of low grade glioma of the CNS
Patients with WHO grade II; may be symptomatic; including patients who are being followed and have radiographic expression
Patients must have a Karnofsky Performance Status of >= 60
Patients must be able to provide informed consent
Patients must have adequate bone marrow function:

WBC >= 4000/mm^3
platelets >= 100,000 mm^3

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

Patients who have had prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma)
Patients with the following histologies:

gliomatosis cerebrei, WHO III or IV gliomas

Patients who have had any prior Radiation treatment
Patients who have had any chemotherapy administered within 30 days of the planned radiation treatment start date
Pregnant women, women planning to become pregnant and women that are nursing
Patients who are actively being treated on any other therapeutic research study