Proton Beam Radiation Therapy in Treating Patients With Low Grade Gliomas
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01024907|
Recruitment Status : Unknown
Verified December 2015 by Abramson Cancer Center of the University of Pennsylvania.
Recruitment status was: Active, not recruiting
First Posted : December 3, 2009
Last Update Posted : December 15, 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 or disease||Intervention/treatment||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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Proton Radiation for Low Grade Gliomas|
|Study Start Date :||July 2009|
|Primary Completion Date :||February 2014|
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 radiationProcedure: quality-of-life assessment
Other Name: quality of life assessmentOther: questionnaire administration
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024907
|United States, Pennsylvania|
|Abramson Cancer Center of The University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Robert Lustig||Abramson Cancer Center of the University of Pennsylvania|