A Phase 1/2 interventional study of proton beam radiation therapy and quality-of-life assessment in Adult Brain Tumor, Adult Brain Stem Glioma and Adult Diffuse Astrocytoma, sponsored by Abramson Cancer Center at Penn Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-10.
Sponsored by Abramson Cancer Center at Penn Medicine · Phase 1/2, Interventional, and Treatment
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.
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.
Patients must have adequate bone marrow function:
Exclusion
gliomatosis cerebrei, WHO III or IV gliomas
Patients undergo proton beam radiation therapy for 6 weeks in the absence of disease progression or unacceptable toxicity.
Radiation: proton beam radiation therapy · Procedure: quality-of-life assessment · Other: questionnaire administration
Undergo radiation
Ancillary study
Ancillary study
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
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
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Abramson Cancer Center at Penn Medicine