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Proton Radiation for Low Grade Gliomas

Phase 1/Phase 2
18 Years
Open (Enrolling)
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

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Trial Information

Proton Radiation for Low Grade Gliomas


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


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.

Inclusion Criteria


- 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:

1. WBC >= 4000/mm^3

2. 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


- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility (phase I)

Safety Issue:


Principal Investigator

Robert Lustig

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania


United States: Institutional Review Board

Study ID:

UPCC 08309



Start Date:

July 2009

Completion Date:

Related Keywords:

  • 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
  • Astrocytoma
  • Brain Neoplasms
  • Ependymoma
  • Glioma
  • Hemangiopericytoma
  • Meningioma
  • Oligodendroglioma
  • Pinealoma



Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283