Clinical Trial: Proton Beam Radiation Therapy in Treating Patients With Low Grade Gliomas

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Proton Radiation for Low Grade Gliomas

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 Summary:

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.


Sponsor: Abramson Cancer Center of the University of Pennsylvania

Current Primary Outcome:

  • 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Abramson Cancer Center of the University of Pennsylvania

Dates:
Date Received: December 2, 2009
Date Started: July 2009
Date Completion:
Last Updated: December 14, 2015
Last Verified: December 2015