Proton Beam Radiation Therapy in Treating Patients With Low Grade Gliomas
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Purpose
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: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Proton Radiation for Low Grade Gliomas |
- Feasibility (phase I) [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
- Late toxicity as graded according to the RTOG/EORTC late morbidity scoring system (phases I and II) [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- Cumulative total dose to normal brain tissue (phase II) [ Designated as safety issue: No ]
- Progression-free survival (phases I and II) [ Designated as safety issue: No ]
- Overall survival (phases I and II) [ Designated as safety issue: No ]
- Adverse events as assessed by NCI CTCAE version 3.0 [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2009 |
| Estimated Primary Completion Date: | July 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:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
- WBC >= 4000/mm^3
- 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
Contacts and Locations| Contact: Robert Lustig, MD | 855-216-0098 | PennCancerTrials@emergingmed.com |
| United States, Pennsylvania | |
| Abramson Cancer Center of The University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Robert Lustig 855-216-0098 PennCancerTrials@emergingmed.com | |
| Principal Investigator: Robert Lustig, MD | |
| Principal Investigator: | Robert Lustig | Abramson Cancer Center of the University of Pennsylvania |
More Information
No publications provided
| Responsible Party: | Lustig, Robert, Abramson Cancer Center of The University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT01024907 History of Changes |
| Other Study ID Numbers: | UPCC 08309, NCI-2009-01442 |
| Study First Received: | December 2, 2009 |
| Last Updated: | February 25, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Astrocytoma Brain Neoplasms Ependymoma Glioma Hemangiopericytoma Meningioma Oligodendroglioma Pinealoma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms 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 |
ClinicalTrials.gov processed this record on May 16, 2013