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Proton Beam Radiation Therapy in Treating Patients With Low Grade Gliomas

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania Identifier:
First received: December 2, 2009
Last updated: December 14, 2015
Last verified: December 2015

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 Intervention 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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Proton Radiation for Low Grade Gliomas

Resource links provided by NLM:

Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • Feasibility (phase I)
  • Acute toxicity as assessed by NCI CTC version 3.0 (phases I and II) [ Time Frame: 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) [ Time Frame: 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

Estimated Enrollment: 50
Study Start Date: July 2009
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: quality of life assessment
Other: questionnaire administration
Ancillary study

Detailed Description:


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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01024907

United States, Pennsylvania
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Principal Investigator: Robert Lustig Abramson Cancer Center of the University of Pennsylvania
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Abramson Cancer Center of the University of Pennsylvania Identifier: NCT01024907     History of Changes
Other Study ID Numbers: UPCC 08309
Study First Received: December 2, 2009
Last Updated: December 14, 2015

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplasms, Vascular Tissue
Meningeal Neoplasms processed this record on May 22, 2017