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A Randomized Phase III Trial Of Pre-Operative Compared To Post-Operative Stereotactic Radiosurgery In Patients With Resectable Brain Metastases
Jacksonville, FL
The purpose of this study is to compare the addition of stereotactic radiosurgery before or after surgery in treating patients with cancer that has spread to the brain (brain metastases).
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EF-32: Pivotal, Randomized, Open-Label Study Of Optune® (Tumor Treating Fields, 200kHz) Concomitant With Radiation Therapy And Temozolomide For The Treatment Of Newly Diagnosed Glioblastoma
Scottsdale/Phoenix, AZ
Jacksonville, FL
The purpose of this study is to test the effectiveness and safety of Optune® given concomitantly with radiation therapy (RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation therapy and temozolomide alone. In both arms, Optune® and maintenance temozolomide are continued following radiation therapy.
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Phase Ib Dose Finding Study Assessing Safety And Activity Of [177Lu]Lu-NeoB In Combination With Radiotherapy And Temozolomide In Subjects With Newly Diagnosed Glioblastoma And As A Single Agent In Recurrent Glioblastoma
Jacksonville, FL
This study will investigate different doses of [177Lu]Lu-NeoB in combination with RT and TMZ in participants with newly diagnosed glioblastoma, with methylated or unmethylated promoter, to assess the safety and efficacy of [177Lu]Lu-NeoB in combination with the SoC and in recurrent glioblastoma as single agent, to identify the recommended dose and to also explore the safety of the PET imaging agent [68Ga]Ga-NeoB and characterize its uptake in the tumor area.
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Phase II Study Of Dose-Reduced Consolidation Radiation Therapy In Patients With Diffuse Large B-cell Lymphoma
Scottsdale/Phoenix, AZ
Jacksonville, FL
Rochester, MN
The purpose of this study is to evaluate whether a reduction in the dose of consolidation radiation therapy (RT) in patients who achieve a negative post-chemotherapy PET-CT scan following 3 to 6 cycles of chemoimmunotherapy, will be associated with a low risk of in-field failure.
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Phase III Trial Of Salvage Stereotactic Radiosurgery (SRS) Or SRS + Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) For First Or Second Distant Brain Relapse After Upfront SRS With Brain Metastasis Velocity >/= 4 Brain Metastases/Year
Jacksonville, FL
The purpose of this study is to compare the effect of adding whole brain radiotherapy with hippocampal avoidance and memantine to stereotactic radiosurgery versus stereotactic radiosurgery alone in treating patients with cancer that has spread to the brain and come back in other areas of the brain after earlier stereotactic radiosurgery. Hippocampus avoidance during whole-brain radiation therapy decreases the amount of radiation that is delivered to the hippocampus, which is a brain structure that is important for memory.
The medicine memantine is also often given with whole brain radiation therapy because it may decrease the risk of side effects of radiation on thinking and memory. Stereotactic radiosurgery delivers a high dose of radiation only to the small areas of cancer in the brain and avoids the surrounding normal brain tissue. Adding whole brain radiotherapy with hippocampal avoidance and memantine to stereotactic radiosurgery may be effective in shrinking or stabilizing cancer that has spread to the brain and returned in other areas of the brain after receiving stereotactic radiosurgery.
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Protocol Title: Phase IIR Trial Of Single Fraction Stereotactic Radiosurgery (SRS) Compared With Fractionated SRS (FSRS) For Intact Metastatic Brain Disease (FRACTIONATE)
Albert Lea, MN
Scottsdale/Phoenix, AZ
Eau Claire, WI
Jacksonville, FL
La Crosse, WI
Mankato, MN
Rochester, MN
All lesions 4.0 cm to 6.0 cm will receive 32.5 Gy/5 fractions and will be analyzed separately. The portion of the trial is written as a phase II study without randomization noting the rarity of unresected brain metastasis of this size and the lack of comfort of treating radiation oncologist and neurosurgeons with single fraction SRS for tumors this large. However, noting the paucity of prospective data for this patient population enrolling patients on a clinical trial will provide a more accurate historical control for future trials. Although this cohort was enrolled on the prospective phase I trial from Emory and the fractionation of 32.5 Gy in 5 fraction appeared safe and efficacious, a larger cohort of patients is needed to better evaluate the therapeutic ratio of this regimen for this patient population.
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