Treatment Trials

204 Clinical Trials for Various Conditions

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SUSPENDED
Spine Radiosurgery for Symptomatic Metastatic Neoplasms
Description

The purpose of this study is to compare three types of radiation therapy for cancer that has spread to the spine. The two types of radiation therapy used in this trial are External Beam Radiation Therapy (EBRT) and Stereotactic Body Radiation Therapy (SBRT). EBRT delivers tightly targeted radiation beams from outside the body. SBRT is a specialized type of radiation therapy that allows high doses of radiation to small targets. This study will include standard dose SBRT and higher dose SBRT. Each participant will be randomly assigned to either EBRT, standard dose SBRT, or higher dose SBRT.

TERMINATED
Stereotactic Radiosurgery With Nivolumab and Valproate in Patients With Recurrent Glioblastoma
Description

The purpose of this study is to evaluate the safety and feasibility of the immunotherapeutic agent nivolumab given in combination with gamma knife therapy and valproate in patients with recurrent glioblastoma, a common and lethal type of brain cancer.

Conditions
TERMINATED
Methionine and PBR28-PET (Peripheral Benzodiazepine Receptors) in Brain Metastases Following Radiosurgery
Description

The goal of this protocol is to evaluate the potential of PET imaging of amino acid transport and microglial activation to improve the differentiation of tumor recurrence and radiation necrosis in patients with brain metastases after treatment with stereotactic radiosurgery (SRS) who have re-growing lesions. These state-of-the-art imaging tools will be used in combination with standard magnetic resonance imaging (MRI), MR spectroscopy (MRS) and FDG-PET (fluorodeoxyglucose).

COMPLETED
Border Zone Stereotactic Radiosurgery With Bevacizumab in Patients With Glioblastoma Multiforme
Description

This is a phase II study on the usage of stereotactic Gamma Knife radiosurgery as a boost to the tumor bed border zone in conjunction with the usage of bevacizumab.

RECRUITING
Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor
Description

The purpose of this study is to determine the changes in quality of life and degree of tremor for patients with essential tremor or Parkinsonian tremor who are treated by stereotactic radiosurgery (SRS). This is a questionnaire-based study. Please see Detailed Description below for more information.

COMPLETED
Phase I Trial of Stereotactic Radiosurgery Following Surgical Resection of Brain Metastases
Description

Brain metastases are the most common adult intracranial tumor, occurring in approximately 10% to 30% of adult cancer patients, and represent an important cause of morbidity and mortality in this population. The standard of care for solitary brain metastasis is surgery followed by whole brain radiation therapy (WBRT). Without WBRT, there are unacceptably high levels of local failure that occur. Local recurrence rates ranged from approximately 45% at 1 year to 60% at 2 years after resection alone. However, aside from improvements in intra-cranial control, it is well documented that WBRT is associated with serious long term side effects, including significant decline in short term recall by as early as 4 months after treatment. Many centers are now offering patients stereotactic radiosurgery (SRS) to the cavity after resection alone to improve local control while avoiding the negative effects of WBRT. There have been several retrospective studies on the use of SRS to the resection cavity alone, from which the 1 year actuarial local control rates range from 35% - 82%. The high rate of in-field local failure suggests that the current dosing regimen used may not be high enough for adequate local control. Currently, the highest local control rates are approximately 80%, but there may be room for improvement with increased dose without significantly increasing the risk of side effects. The investigators propose a trial for patients after surgical resection of solitary brain metastases. The purpose of this trial will be to determine the maximum tolerated dose for single fraction SRS to the resection cavity. There will be three groups based on the resection cavity size. Dose escalation enrollment will be done sequentially within each cohort. You will know which cohort and which specific dose level you are randomized to. After treatment, which will take one day, regardless of cohort, you will be followed closely for treatment outcome and possible side effects. You will be asked to complete three quick surveys at each follow-up appointment regarding quality of life and memory in addition to standard of care surveillance brain MRI and physical exam.

TERMINATED
Radiosurgery for Patients With Oligometastatic Disease at Initial Presentation
Description

This study will evaluate the feasibility of radiosurgery for all metastatic sites in patients presenting with oligometastatic disease, defined here as 5 or fewer sites of metastatic disease involving 3 or fewer organ systems.

UNKNOWN
Multi-Institutional Registry for Prostate Cancer Radiosurgery
Description

To address pertinent questions regarding the utilization of stereotactic Body Radiotherapy (SBRT) to treat prostate cancer. The Florida Robotic Radiosurgery Association (FRRA) launched the first registry for prostate cancer patients treated with SBRT. The registry is designed to track surrogate treatment endpoints including prostate specific antigen (PSA), international prostate symptom score (IPSS),sexual health in men (SHIM), and visual analogue scale (VAS) scores, in addition to physical and survival data. Utilizing an independent vendor (Advertek, Inc.) experienced with the design and implementation of similar electronic registries, FRRA developed a data collection tool that staff members with a basic medical background can use to register and upload pertinent patient data, requiring no more than 20 to 30 minutes per patient. Participating patients will be monitored in follow-up for three years, with analysis and publication of the results semi-annually.

UNKNOWN
Stereotactic Hypofractionated Radiosurgery for Early Stage Prostate Cancer
Description

The purpose of this trial is to evaluate a short course of very focused (stereotactic) external beam radiation therapy for the treatment of early stage prostate cancer. The investigators will gather scientific information about the tolerance and side effects this type of radiation. The investigators will then compare these results with those of standard 8 week course of external beam radiation therapy to see if this study treatment is equally or more effective in treating prostate cancer.

Conditions
COMPLETED
Radiosurgery or Open Surgery for Epilepsy Trial
Description

This study will compare radiosurgery (focused radiation, Gamma Knife Radiosurgery) with temporal lobectomy (standard surgical care) as a treatment of temporal lobe epilepsy. Patients who have seizures that begin in their temporal lobe that are not controlled with medications into the trial will be offered entry. Patients with a high likelihood of having their seizures controlled with open surgery will have treatment randomized between the standard surgery and radiosurgery. A prior study has shown that focused radiation (radiosurgery) may also reduce or eliminate seizures arising from the temporal lobe. The main study hypothesis is that radiosurgery is as safe and effective as temporal lobectomy in treating patients with seizures arising from the medial temporal lobe.

Conditions
COMPLETED
CyberKnife Radiosurgery For Low & Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry
Description

The purpose of this study is to investigate the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer and to evaluate the effects of this treatment on the quality of life over time.

COMPLETED
Phase II Trial of Stereotactic Radiosurgery Boost Following Surgical Resection for Brain Metastases
Description

For patients who have one or two metastases in the brain, the tumor(s) can often be removed with surgery to relieve symptoms from the tumor(s) and to improve survival. However, about half of all patients who have the tumor(s) removed with surgery will develop regrowth (recurrence) of the tumor. To prevent this regrowth of tumor, some patients receive radiation to the entire brain (whole brain radiation) after surgery. This involves daily treatment for about two to three weeks, and may cause long-term neurological problems, such as memory loss. Stereotactic radiosurgery (SRS) is sometimes used instead of surgery to treat brain metastasis. This involves the use of a special head frame and sophisticated computer programs that enable us to deliver a high dose of radiation to a small focused area of the brain in only one treatment. Research has shown that the results of treatment with SRS are as good as surgical removal of the tumor. SRS and surgical resection are considered the standard options for the treatment of brain metastases. This Phase II clinical trial is studying the combination of these two techniques. The purpose of this study is to evaluate the use of SRS following surgical removal of brain metastases. The outcomes we will be looking at are tumor regrowth after treatment and side effects of treatment.

TERMINATED
Neural Stem Cell Preserving Brain Radiation Therapy & Stereotactic Radiosurgery in Patients With 1-6 Brain Metastases
Description

For patients with 1-6 intraparenchymal brain metastases from various primary histologies (except for melanoma), stereotactic radiosurgery (administered upfront or concurrently) or complete surgical resection with neural stem cell (NSC)-preserving whole-brain radiotherapy (WBRT) results in improved neurocognitive profile over standard WBRT. The goal of this study is to assess feasibility of this treatment approach.

COMPLETED
A Phase II Study of Spinal Radiosurgery
Description

Phase I of the study (motion and quality assurance \[QA\] study) is being used to determine intrafraction target motion and define quality assurance procedures for single fraction spinal radiosurgery. The Phase II portion of the study is being used to estimate the palliative response (pain or relief of neurologic symptoms) and local control for single fraction radiosurgery delivered with TomoTherapy and to assess the acute and late toxicity of spinal radiosurgery.

WITHDRAWN
A Pilot Study of CyberKnife Radiosurgery Delivered to the Partial Breast
Description

This pilot study will evaluate the technical feasibility and acute toxicity of Partial Breast Irradiation (PBI) with the CyberKnife in anticipation of a larger multi-institutional Phase II study. It will evaluate quality of life (QOL) issues as they relate to treatment related side effects, cosmetic result, and patient convenience. Radiosurgery is defined as the stereotactic delivery of ionizing radiation in 5 stages or less to a designated target with sub-millimeter accuracy. Radiosurgery in the context of this protocol will be given to the region of the tumor bed within 7 weeks of lumpectomy and sentinel/axillary node sampling over a period of five to ten days using the CyberKnife (CK). Subjects will receive CK before chemotherapy, if applicable.

Conditions
TERMINATED
Study of Motexafin Gadolinium With Whole Brain Radiation Therapy Followed by Stereotactic Radiosurgery Boost in the Treatment of Patients With Brain Metastases
Description

The primary purpose of the study is to evaluate if motexafin gadolinium with whole brain radiation therapy followed by a stereotactic radiosurgery boost is a safe and effective treatment.

COMPLETED
Surgery Versus Radiosurgery to Treat Metastatic Brain Tumors
Description

This study will compare the effectiveness of craniotomy to that of stereotactic surgery (SRS) for the treatment of metastatic brain tumors - tumors that first develop elsewhere in the body and then travel to the brain. Craniotomy is surgical removal of the tumors through an operation. SRS consists of highly focused radiation doses to the tumors. Neither treatment is experimental and both have shown benefits to patients with metastatic brain tumors. This study will determine whether one treatment is superior to the other in prolonging patient survival. Patients 21 years of age and older with one to three metastatic brain tumors may be eligible for this study. Participants will have a medical history and physical examination, blood and urine tests, an electrocardiogram, and chest x-ray. They will then be randomly assigned to undergo either surgery or SRS. Before either procedure, patients will have a magnetic resonance imaging (MRI) scan. MRI uses a strong magnetic field and radio waves to obtain images of the brain. Patients scheduled for SRS will have a computed tomography (CT) scan in addition to the MRI. CT uses X-rays to obtain images of the brain. During the CT, a contrast agent is injected through an IV tube placed in a vein to enhance the CT images. For both the MRI and CT tests, the patient lies on a table that slides into a cylindrical scanner. The MRI usually lasts between 45 and 90 minutes, while the CT scan lasts for about 30 to 60 minutes. Patients scheduled for surgery will have general anesthesia or local anesthesia with sedation. They will be in intensive care after the surgery until their condition is stable. Before being discharged home, they will have another MRI scan. The surgical sutures or staples will be removed 7 to 10 days after surgery. Patients scheduled for SRS will have their scalp numbed with medicine and their head will be placed in a head frame. A CT scan will be done on the morning of the procedure to plan the treatment. Around noon, the treatment, which consists of brief exposures to radiation, will be administered with the patient positioned comfortably on a treatment couch. The treatment will be completed in 1 to 2 hours, after which the head frame will be removed. After a brief period of observation, the patient will be discharged home. Patients will return to NIH for follow-up visits within 4 weeks after surgery or SRS and then every 3 months after that for a medical history, physical examination, and MRI scan, and to complete a quality of life questionnaire.

RECRUITING
Trial of Differential Margins in Single Isocenter Radiosurgery of Brain Metastases
Description

Radiosurgery is the use of a focal high dose of radiation therapy to ablate or kill a tumor. This trial will enroll patients with brain metastases 4 cm or less in greatest diameter and will compare 0mm margin to a 2mm margin for treatment.

RECRUITING
A Study of Stereotactic Radiosurgery (SRS) and Standard Treatment in People With Lung Cancer That Has Spread to the Brain
Description

The researchers are doing this study is to find out whether treating brain metastasis with SRS after 3 months of therapy with osimertinib is better than treating with osimertinib alone in people with NSCLC. The researchers will also look at how the study intervention impacts participants' quality of life. The researchers will measure quality of life by having participants complete questionnaires.

RECRUITING
EXCLAIM: Exploring Combined Local and Systemic Approaches In Brain Metastasis: a Multi-cohort Randomized Phase II Study Evaluating Initial Response to Systemic Therapy and Subsequent Integration of Stereotactic Radiosurgery in Patients With Low-risk Brain Metastases and Central Nervous System-active
Description

To learn if consolidative stereotactic radiosurgery (cSRS) can help to control central nervous system (CNS) disease in patients who have brain metastases and have a partial response or stable brain metastases after systemic therapy. To learn if using SRS to treat all brain metastases that do not respond to systemic therapy versus treating only metastases that are getting worse can help to control CNS disease in patients whose disease gets worse after systemic therapy.

RECRUITING
Loncastuximab Tesirine and Rituximab Following Stereotactic Radiosurgery (SRS) in Patients With Primary and Secondary Central Nervous System Lymphomas (Lonca-R After SRS in CNSL)
Description

The purpose of this clinical trial is to learn if drugs loncastuximab tesirine and rituximab (lonca-R) after stereotactic radiosurgery are safe and effective for treatment of central nervous system lymphomas.

RECRUITING
Adjuvant Hypofractionated Stereotactic Radiosurgery for Intermediate-risk Meningioma
Description

This clinical trial tests the safety and effectiveness of hypofractionated stereotactic radiosurgery for treating patients who have undergone surgical resection for grade II meningiomas or grade I meningiomas that have come back after a period of improvement (recurrent). Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Stereotactic radiosurgery is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Hypofractionated stereotactic radiosurgery may be safe, tolerable, and effective in treating patients with grade II or recurrent grade I meningiomas after surgical resection.

NOT_YET_RECRUITING
Dose-escalation Study of Ultra-high Dose Ablative Radiosurgery With Immunotherapy for Bulky Metastatic Cancer Patients
Description

The purpose of this study is to determine whether cytoreduction of bulky metastatic disease using ultra high dose SBRT in combination with immunotherapy is tolerable and feasible In patients who have exhausted SoC treatment options.

Conditions
RECRUITING
Hypophysectomy by Stereotactic Radiosurgery for Cancer-Related Pain
Description

To learn if hypophysectomy (treatment of the pituitary gland) using a type of radiation treatment called stereotactic radiosurgery (SRS) can help to relieve cancer-related pain.

Conditions
RECRUITING
Risk Adapted Spinal Cord/Cauda Constraint Relaxation for High-risk Patients With Metastatic Epidural Spinal Cord Compression Undergoing Spine Stereotactic Radiosurgery
Description

To learn about the safety of a procedure called cord dose escalated spine stereotactic radiosurgery (CDE-SSRS) in patients with MESCC.

RECRUITING
Comparing SingLe- Vs Multi-Fraction Spine STereotActic Radiosurgery in Spinal Metastases
Description

The goal of this study is to determine whether fractionated Stereotactic radiosurgery (SRS) for spine metastases is associated with improved local tumor control compared to single-fraction SRS. Patients will be randomized to treatment with spine SRS using either 22 Gy in 1 fraction or 28 Gy in 2 fractions.

RECRUITING
Radiosurgery Treatment for Spasticity Associated With Stroke, SCI & Cerebral Palsy
Description

A scientific study is being done to test a special treatment for people who have spasticity or tight muscles. This treatment is called "stereotactic radiosurgery dorsal rhizotomy." It uses very accurate beams of radiation to target certain nerves in the back to help loosen up the muscles. In this study, people are put into two groups by chance: one group gets the real treatment, and the other group gets a "fake" treatment that doesn't do anything. This fake treatment is called a "sham." Doing this helps make sure the study is fair and the results are true. After the people in the study get their treatment, the researchers will watch and see how they do. They will check if their muscles are less stiff and if they have any side effects. By looking at the results from both groups, the researchers can find out if the special treatment really helps people with spasticity. Patients who got the "fake" treatment will be eligible to receive the "real" treatment after 6 months.

RECRUITING
18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery
Description

This is a pilot imaging study in participants treated with stereotactic radiosurgery (SRS) to treat brain metastasis. The purpose of this study is to see whether 18F-Fluciclovine positron emission tomography (PET) can be used as a biomarker to measure response or progression of brain metastasis after SRS.

RECRUITING
A Study of Stereotactic Radiosurgery (SRS) to Treat Pain in the Chest and/or Stomach Wall
Description

The researchers are doing this study to find out whether stereotactic radiosurgery (SRS) is a safe, practical (feasible), and effective treatment for people with chronic TAWP. The researchers will test different doses of SRS to find the highest dose that causes few or mild side effects.

SUSPENDED
A Study of Oral IRAK-4 Inhibitor CA-4948 in Combination With Pembrolizumab and Stereotactic Radiosurgery in Patients With Melanoma Brain Metastases
Description

This phase I/II trial will investigate the use of the novel oral IRAK-4 inhibitor CA-4948 in combination with pembrolizumab therapy following stereotactic radiosurgery (SRS) in patients with melanoma brain metastases (MBM). The investigators hypothesize that the addition of CA-4948 will reduce the rate of distant intracranial failure and reduce the need for subsequent radiation therapy. The investigators also propose that it will have a significant reduction in radiation necrosis and improve patient-reported symptoms and quality of life. This trial represents the first time an oral IRAK-4 inhibitor has been used in combination with aPD1 therapy in MBM and will yield valuable insight into its synergistic potential both in MBM and additional sites of metastases.