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| Name | Class |
|---|---|
| Keep Punching Foundation | UNKNOWN |
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The purpose of this study is to evaluate the treatment regimen of using Laser Interstitial Thermal Therapy (LITT) and Hypo-fractionated Radiation Therapy to treat patients with newly diagnosed gliomas.
Radiation therapy is preferably used as an adjunct to surgery for patients with a newly diagnosed or recurrent glioblastoma. LITT offers an alternative to surgical resection, and due to its minimally invasive nature, does not delay initiating radiation therapy. Another advantage of LITT prior to radiation therapy is the ability to obtain a tissue diagnosis of the tumor prior to initiating radiation therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LITT with Hypofractionated RT | Experimental | Laser interstitial thermal therapy (LITT) followed by hypo-fractionated radiation therapy, 25Gy/10 fractions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LITT | Procedure | This procedure is done under MRI guidance and employs low-powered thermal energy to achieve tumor ablation through coagulation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | The ability to complete protocol treatment (i.e. LITT and radiation therapy) without undue treatment-related acute toxicity as defined below:
| 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival at 6 months | To describe progression-free survival rate in subjects with newly diagnosed high-grade gliomas treated with Laser Interstitial Thermal Therapy | 6 months |
| Median progression-free survival |
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Inclusion Criteria:
Exclusion Criteria:
Patients that are not surgical candidates for stereotactic biopsy or laser ablation
Patients with impaired cardiac function or clinically significant cardiac diseases, including any of the following:
Infratentorial tumor or evidence of leptomeningeal spread
Inability to undergo a MRI
Pregnant or breast-feeding women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark Mishra, MD | Contact | 410-328-6080 | mmishra@umm.edu | |
| Caitlin Eggleston, BS | Contact | 410-328-7586 | caitlineggleston@umm.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maryland Proton Treatment Center | Recruiting | Baltimore | Maryland | 21201 | United States |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| D005909 | Glioblastoma |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| Hypofractionated Radiation Therapy | Radiation | Treatments will be delivered once daily on consecutive treatment days (typically 5 fractions per week). Radiation therapy simulation is to be performed within 10 days of the LITT procedure. |
|
To describe median progression-free survival rate in subjects with newly diagnosed high-grade gliomas treated with Laser Interstitial Thermal Therapy followed by hypofractionated radiation therapy.
| 2 years |
| Median overall survival | To describe median progression-free survival rate in subjects with newly diagnosed high-grade gliomas treated with Laser Interstitial Thermal Therapy followed by hypofractionated radiation therapy. | 2 years |
| 1-year overall survival | To describe 1- year survival rate in subjects with newly diagnosed high-grade gliomas treated with Laser Interstitial Thermal Therapy followed by hypofractionated radiation therapy. | 1 year |
| Overall response rate | To describe overall response rate in subjects with newly diagnosed high-grade gliomas treated with Laser Interstitial Thermal Therapy followed by hypofractionated radiation therapy. | 2 years |
| Quality of Life assessed by M.D. Anderson Symptom Inventory | Patient reported quality of life impact from undergoing LITT followed by hypofractionated radiation therapy using the M.D. Anderson Symptom Inventory- Brain Tumor (MDASI-BT) questionnaire. | 2 years |
| University of Maryland Greenebaum Cancer Center | Recruiting | Baltimore | Maryland | 21201 | United States |
|
| UCH Kaufman Cancer Center | Recruiting | Bel Air | Maryland | 21014 | United States |
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| Central Maryland Radiation Oncology | Recruiting | Columbia | Maryland | 21044 | United States |
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| Baltimore Washington Medical Center | Recruiting | Glen Burnie | Maryland | 21061 | United States |
|
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001254 | Astrocytoma |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |