View Clinical Trial (Medical Research Study)
Proton Radiation for Low Grade Gliomas
| City: |
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Philadelphia |
| State: |
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Pennsylvania |
| Zip Code: |
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19104 |
| Conditions: |
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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 Astr |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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:
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
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
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| NCT ID: |
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NCT01024907 |
| Primary Contact: |
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Principal Investigator
Robert Lustig
Abramson Cancer Center of the University of Pennsylvania
Robert Lustig, MD
Phone: 855-216-0098
Email: PennCancerTrials@emergingmed.com
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| Backup Contact: |
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N/A |
| Location Contact: |
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Philadelphia, Pennsylvania 19104
United States
Robert Lustig
Phone: 855-216-0098
Email: PennCancerTrials@emergingmed.com
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
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