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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-01442 |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients undergo proton beam radiation therapy for 6 weeks in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| proton beam radiation therapy | Radiation | Undergo radiation |
| |
| quality-of-life assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility (phase I) | ||
| Acute toxicity as assessed by NCI CTC version 3.0 (phases I and II) | 60 days (phase I) or 90 days (phase II) from completion of radiation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Pre-radiation, mid-treatment, and post-radiation; at 3, 6, 9, and 12 months post-radiation; and then every 6 months |
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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:
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
gliomatosis cerebrei, WHO III or IV gliomas
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| Name | Affiliation | Role |
|---|---|---|
| Robert Lustig | Abramson Cancer Center at Penn Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center of The University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23388559 | Derived | Maquilan G, Grover S, Alonso-Basanta M, Lustig RA. Acute toxicity profile of patients with low-grade gliomas and meningiomas receiving proton therapy. Am J Clin Oncol. 2014 Oct;37(5):438-43. doi: 10.1097/COC.0b013e31827de86b. |
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| Procedure |
Ancillary study |
|
| questionnaire administration | Other | Ancillary study |
|
| 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 |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D001254 | Astrocytoma |
| D004806 | Ependymoma |
| D005910 | Glioma |
| D009837 | Oligodendroglioma |
| D010871 | Pinealoma |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D061766 | Proton Therapy |
| ID | Term |
|---|---|
| D063193 | Heavy Ion Radiotherapy |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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