Search Clinical Trials
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Sleep Spindles and Memory in Rolandic Epilepsy
Massachusetts General Hospital
Rolandic Epilepsy
Rolandic Epilepsy, Benign
Centrotemporal Epilepsy
Centrotemporal; EEG Spikes, Epilepsy of Childhood
Epilepsy; Seizure
The investigators are recruiting children with Rolandic epilepsy and children without
epilepsy (aged 4 years old and above) for a non-invasive brain imaging study using Magnetic
Resonance Imaging (MRI), Magnetoencephalography/Electroencephalography (MEG/EEG), and
experimental... expand
The investigators are recruiting children with Rolandic epilepsy and children without epilepsy (aged 4 years old and above) for a non-invasive brain imaging study using Magnetic Resonance Imaging (MRI), Magnetoencephalography/Electroencephalography (MEG/EEG), and experimental tasks. The investigators hope to determine the brain circuits and brain rhythms affected in these children and ultimately identify new treatment options for childhood epilepsy patients. Type: Interventional Start Date: Jan 2021 |
Abemaciclib + Letrozole +/- Metformin in Recurrent or Persistent Endometrial Cancer
Dana-Farber Cancer Institute
Endometrial Cancer
This research study is studying a combination of targeted therapies as a possible treatment
for estrogen-receptor positive (ER+) endometrial cancer.
The drugs involved in this study are:
- Abemaciclib (also known as Verzenio™)
- Letrozole (also known as... expand
This research study is studying a combination of targeted therapies as a possible treatment for estrogen-receptor positive (ER+) endometrial cancer. The drugs involved in this study are: - Abemaciclib (also known as Verzenio™) - Letrozole (also known as Femara®) - Metformin (also known as Glucophage®) Type: Interventional Start Date: Dec 2018 |
Turmeric for Patients With Basal Joint Arthritis
Massachusetts General Hospital
Thumb Osteoarthritis
The aim of this study is to assess whether the use of a commercially available nutraceutical,
turmeric, is an effective option to manage pain and stiffness in patients with basal joint
arthritis. To conduct a pilot Randomized Controlled Trial evaluating the impact of turmeric... expand
The aim of this study is to assess whether the use of a commercially available nutraceutical, turmeric, is an effective option to manage pain and stiffness in patients with basal joint arthritis. To conduct a pilot Randomized Controlled Trial evaluating the impact of turmeric on basal joint arthritis. Type: Interventional Start Date: Aug 2017 |
Remote Monitoring in Progressive Supranuclear Palsy (PSP)
Massachusetts General Hospital
Progressive Supranuclear Palsy
This is a single-arm, longitudinal, observational study on the use of wearable sensors and
digital health technology to measure fall frequency and motor, speech, and cognitive function
in patients with PSP over the course of approximately one year. Participants will perform... expand
This is a single-arm, longitudinal, observational study on the use of wearable sensors and digital health technology to measure fall frequency and motor, speech, and cognitive function in patients with PSP over the course of approximately one year. Participants will perform supervised remote assessments monthly and in-person assessments approximately every 6 months. Type: Observational Start Date: May 2021 |
Medically Intensive Nutrition Therapy Program for Obesity and Diabetes in a Low-income Population
Massachusetts General Hospital
Overweight
PreDiabetes
Diabetes Type 2
Obesity
This study is being done to better understand whether meal replacements can be an effective
tool for weight loss and treatment of elevated blood sugars in people with obesity/overweight
and diabetes/pre-diabetes who have a low income.
expand
This study is being done to better understand whether meal replacements can be an effective tool for weight loss and treatment of elevated blood sugars in people with obesity/overweight and diabetes/pre-diabetes who have a low income. Type: Observational Start Date: Apr 2023 |
Peripheral Neuroimmune Mechanisms of Hyperthermia
Massachusetts General Hospital
Hyperthermia
Major Depressive Disorder
Inflammation
The goal of this study is to examine how whole-body hyperthermia affects the
thermoinflammatory profile, which includes the combined immune and heat shock response, in
patients with depression and whether these changes correlate with decreased depression in
individuals with... expand
The goal of this study is to examine how whole-body hyperthermia affects the thermoinflammatory profile, which includes the combined immune and heat shock response, in patients with depression and whether these changes correlate with decreased depression in individuals with Major Depressive Disorder. Type: Interventional Start Date: Nov 2022 |
Biomechanical Precision Medicine Registry for Patients With and Without Heart Failure
Massachusetts General Hospital
Heart Failure With Normal Ejection Fraction
Heart Failure With Reduced Ejection Fraction
Heart Failure, Right Sided
Heart Failure With Mid Range Ejection Fraction
Cardiovascular Risk Factor
In this single-center, longitudinal observational study, we will comprehensively examine
clinical characteristics, proteomic, metabolomic, genomic and imaging data to better
understand how different heart failure types may develop and progress over time. We will
evaluate distinct... expand
In this single-center, longitudinal observational study, we will comprehensively examine clinical characteristics, proteomic, metabolomic, genomic and imaging data to better understand how different heart failure types may develop and progress over time. We will evaluate distinct sub-groups of heart failure (also known as heart failure phenotypes) and cardiomyopathies including amyloidosis with an ultimate goal of bringing the right medications and therapy to the right patients to optimize benefit and minimized side effects, an effort to improve precision medicine in heart failure. Type: Observational [Patient Registry] Start Date: Apr 2016 |
Endoscopic Ultrasound Shear Wave Elastography in Patients With Non-alcoholic Fatty Liver Disease
Brigham and Women's Hospital
Non-Alcoholic Fatty Liver Disease
Non-alcoholic Steatohepatitis
Obesity
The goal of this observation study is to assess whether endoscopic ultrasound shear wave
elastography (EUS-SWE) may be a useful tool for liver fibrosis screening in patients with
elevated body mass index and non alcoholic fatty liver disease as compared to other
non-invasive... expand
The goal of this observation study is to assess whether endoscopic ultrasound shear wave elastography (EUS-SWE) may be a useful tool for liver fibrosis screening in patients with elevated body mass index and non alcoholic fatty liver disease as compared to other non-invasive screening modalities, which have traditionally had less accurate results in this population. The main questions it aims to answer are: - Determine accuracy of EUS-SWE for liver fibrosis screening compared to other non-invasive scoring systems, such as the FIB-4 score and Fibroscan in patients with elevated body mass index - Establish optimal stiffness (kPa) cutoffs for liver fibrosis grading for EUS-SWE for this patient population in reference to the gold standard liver biopsy, as no standard cutoffs currently exist. Participants will undergo routine endoscopic ultrasound as part of their standard clinical care and indication. Participants are consented for the procedure and undergoing the shear wave elastography. In addition to their standard ultrasound test, it takes on average an extra 2-3 minutes to perform the shear wave elastography. The procedure itself adds no additional risk to the patient and does not expose them to radiation. Type: Observational [Patient Registry] Start Date: Jun 2021 |
An Anesthesia-Centered Bundle to Reduce Postoperative Pulmonary Complications: The PRIME-AIR Study
Columbia University
Postoperative Pulmonary Complications
Postoperative pulmonary complications (PPCs) are a major cause of morbidity and mortality in
surgical patients. National estimates suggest 1,062,000 PPCs per year, with 46,200 deaths,
and 4.8 million additional days of hospitalization. The objective of the study is to develop... expand
Postoperative pulmonary complications (PPCs) are a major cause of morbidity and mortality in surgical patients. National estimates suggest 1,062,000 PPCs per year, with 46,200 deaths, and 4.8 million additional days of hospitalization. The objective of the study is to develop and implement perioperative strategies to eliminate PPCs in abdominal surgery, the field with the largest absolute number of PPCs. We will conduct a randomized controlled pragmatic trial in 750 studied participants. The effectiveness of an individualized perioperative anesthesia-centered bundle will be compared to the usual anesthetic care in patients receiving open abdominal surgery. At the end of this project, the investigators expect to change clinical practice by establishing a new and clinically feasible anesthesia-centered strategy to reduce perioperative lung morbidity. The research will be conducted across 14 US academic centers, and will be funded by the National Institute of Health. Type: Interventional Start Date: Jan 2020 |
Enhancing Acupuncture Treatment Effect Through Non-invasive Neuromodulation
Massachusetts General Hospital
Chronic Pain
In this study, investigators will examine the brain mechanism behind the synergistic effects
of combining acupuncture and transcranial direct current stimulation (tDCS) treatments.
Specifically, chronic low back pain (cLBP) patients will be recruited and randomized to one... expand
In this study, investigators will examine the brain mechanism behind the synergistic effects of combining acupuncture and transcranial direct current stimulation (tDCS) treatments. Specifically, chronic low back pain (cLBP) patients will be recruited and randomized to one of four groups (30 per group, one month of treatment): 1) verum acupuncture + real tDCS, 2) sham acupuncture + real tDCS, 3) verum acupuncture + sham tDCS, and 4) sham acupuncture + sham tDCS. Investigators will study 1) the longitudinal (one-month) effects of different treatments as indicated by changes in resting state functional connectivity (rsFC), cerebral blood flow (CBF), clinical outcomes of low back pain, and quantitative sensory test (QST) and 2) the association between these changes. Type: Interventional Start Date: Nov 2020 |
Randomized Control Trial of CO2 Laser to Treat Hypertrophic Burn Scar
Massachusetts General Hospital
Burns
Hypertrophic Scar
Laser treatment of hypertrophic burn scars has become increasingly popular for improving
scarring in burn survivors. Despite its common use, there a gap in knowledge regrading
randomized control trials that demonstrate whether the laser is beneficial. Such a trial is
important... expand
Laser treatment of hypertrophic burn scars has become increasingly popular for improving scarring in burn survivors. Despite its common use, there a gap in knowledge regrading randomized control trials that demonstrate whether the laser is beneficial. Such a trial is important because if it shows the laser does work, it would provide the evidence to make such treatments more accessible to all patients. Furthermore, there is no knowledge whether the burn injury used to remove tissue is beneficial or not. This study aims to evaluate the laser treatment, removal of similar tissue amounts with 0.5mm punch biopsies, to controls to fill this knowledge gap. The hypothesis is the laser is beneficial at improving patient's burn scars. Also the punch biopsies work better at improving scars by removing tissue without burning and injuring the surrounding tissue as the laser does. To evaluate these treatments (laser, punch biopsies, and no treatment), 3 small areas will be chosen in a study scar area that meets specific criteria to receive . Patients will still be able to receive laser and burn reconstruction procedures in all other areas not involving the study scar area that are clinically indicated. In the study, the scar will be evaluated with photographs, surveys, and tissue samples taken either while under anesthesia except for one set taken with numbing medicine. The tissue samples will be looked at under a microscope to see how the treatments change the scar tissue. The tissue will also have tests done to evaluate how the laser impacts genes from cells in the scar tissue. Lastly, to understand how reconstructive procedures (laser and surgical treatments) change a patient's quality of life, patients will be asked a limited set of questions to learn more how these procedures improve their lives. Type: Interventional Start Date: Mar 2019 |
Long-Term Maintenance With Ketamine and Esketamine for Reduction of Suicide in High-Risk Patients With...
Massachusetts General Hospital
Major Depressive Disorder
The study will consist of a 24-week-long trial examining outcomes in patients with Major
Depressive Disorder and suicidal ideation who will receive intravenous (IV) ketamine and
intranasal (IN) esketamine, compared to a large sample of matched historical controls.
Patients... expand
The study will consist of a 24-week-long trial examining outcomes in patients with Major Depressive Disorder and suicidal ideation who will receive intravenous (IV) ketamine and intranasal (IN) esketamine, compared to a large sample of matched historical controls. Patients will be recruited from an inpatient psychiatric unit. Eligible patients who provided informed consent will be enrolled in the study that will include a eight IV ketamine treatments, 13 esketamine treatment visits, seven long assessment visits, five short assessment visits, and daily surveys. The study will examine the feasibility, tolerability, and efficacy of repeated IV ketamine followed by esketamine, as well as predictors of treatment response. Type: Interventional Start Date: Oct 2022 |
Effectiveness of an Integrated Treatment to Address Smoking Cessation and Anxiety/ Depression in People...
Massachusetts General Hospital
Human Immunodeficiency Virus
Smoking Cessation
Smoking, Cigarette
Smoking
Anxiety
Smokers living with HIV represent a major health disparity population in the United States
and the world more generally. Major contributing factors to the maintenance and relapse of
smoking among smokers living with HIV include increased exposure to multiple stressors
associated... expand
Smokers living with HIV represent a major health disparity population in the United States and the world more generally. Major contributing factors to the maintenance and relapse of smoking among smokers living with HIV include increased exposure to multiple stressors associated with HIV, which often exacerbates anxiety/depression. In a previous project, the feasibility, acceptability, and initial efficacy of a 9-session, cognitive-behavioral-based intervention to address smoking cessation by reducing anxiety and depression via specific emotional vulnerabilities (anxiety sensitivity, distress tolerance, and anhedonia) was tested against an enhanced standard of care in a pilot randomized controlled trial (NCT01393301). It was found that when compared to a brief enhanced treatment as usual control, patients in the intervention achieved higher short-term and long-term smoking abstinence rates. In this project, the investigators seek to test this same intervention in a fully powered, 3-arm efficacy/effectiveness trial. The goal of this study is to randomize 180 smokers across three sites to test the efficacy/effectiveness of the intervention at increasing point prevalence abstinence by reducing anxiety and depression at a 1-month follow-up (the end of treatment timepoint/ approximately 1-month post quit day) and a 6-month follow-up (approximately 6-months post quit day). Type: Interventional Start Date: Dec 2019 |
Modulation Effects of Baduanjin Exercise on Subjective Cognitive Decline
Massachusetts General Hospital
Cognitive Decline
The aim of this study is to investigate the modulation effects of Baduanjin (BDJ), a simple
and innovative mind-body exercise, on cognitive function, resting state functional
connectivity, and brain morphometry in individuals with subjective cognitive decline (SCD).
The results... expand
The aim of this study is to investigate the modulation effects of Baduanjin (BDJ), a simple and innovative mind-body exercise, on cognitive function, resting state functional connectivity, and brain morphometry in individuals with subjective cognitive decline (SCD). The results obtained will provide novel insights for improving the prevention of age-related cognitive decline and Alzheimer's disease. Type: Interventional Start Date: Aug 2020 |
Effects of Nitric Oxide on the Endothelium During Hemolysis.
Massachusetts General Hospital
Endothelial Dysfunction
Hemolysis Intravascular
Cardiovascular Diseases
Cardiovascular Risk Factor
This study is an ancillary (add-on) study to the clinical trial entitled "Effect of Nitric
Oxide in Cardiac Surgery Patients With Endothelial Dysfunction", which has Clinical
Trials.gov identifier NCT02836899. NCT02836899 trial randomizes cardiac surgical patients to
receive... expand
This study is an ancillary (add-on) study to the clinical trial entitled "Effect of Nitric Oxide in Cardiac Surgery Patients With Endothelial Dysfunction", which has Clinical Trials.gov identifier NCT02836899. NCT02836899 trial randomizes cardiac surgical patients to receive either Nitric Oxide (NO) or a placebo during and after cardiac surgery. This ancillary study aims to assess the effects of Nitric Oxide on vascular responsiveness and on endothelial function during hemolysis in patients with pre-operative endothelial dysfunction undergoing cardiac surgery requiring prolonged cardiopulmonary bypass. Type: Interventional Start Date: Dec 2018 |
The Genomic Medicine at VA Study
Boston VA Research Institute, Inc.
Coronary Artery Disease
Atrial Fibrillation
Type 2 Diabetes
Colorectal Cancer
Breast Cancer
This trial will determine the clinical effectiveness of polygenic risk score testing among
patients at high genetic risk for at least one of six diseases (coronary artery disease,
atrial fibrillation, type 2 diabetes mellitus, colorectal cancer, breast cancer, or prostate... expand
This trial will determine the clinical effectiveness of polygenic risk score testing among patients at high genetic risk for at least one of six diseases (coronary artery disease, atrial fibrillation, type 2 diabetes mellitus, colorectal cancer, breast cancer, or prostate cancer), measured by time-to-diagnosis of prevalent or incident disease over 24 months. Type: Interventional Start Date: Jul 2020 |
Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary...
Massachusetts General Hospital
Hepatocellular Carcinoma
Biliary Tract Cancer
This research study is studying a combination of drugs as a possible treatment for
Hepatocellular Carcinoma or Biliary Tract Cancer.
The interventions involved in this study are:
- Durvalumab
- Tremelimumab
- Radiation Therapy
expand
This research study is studying a combination of drugs as a possible treatment for Hepatocellular Carcinoma or Biliary Tract Cancer. The interventions involved in this study are: - Durvalumab - Tremelimumab - Radiation Therapy Type: Interventional Start Date: May 2018 |
Lung-Resident Memory Th2 Cells in Asthma
Andrew D. Luster, M.D.,Ph.D.
Asthma, Allergic
Determining how memory T helper type 2 (Th2) initiate recall responses to aeroallergens has
the potential to change the therapeutic approach to allergic asthma, the most common asthma
subtype. ~5-10% of effector Th2 cells recruited into the lung give rise to long-lived tissue... expand
Determining how memory T helper type 2 (Th2) initiate recall responses to aeroallergens has the potential to change the therapeutic approach to allergic asthma, the most common asthma subtype. ~5-10% of effector Th2 cells recruited into the lung give rise to long-lived tissue resident memory cells that are poised to respond upon allergen re-exposure.Consequently, targeting memory Th2 cell activation is an attractive therapeutic strategy. However, it is not well understood how allergen inhalation initiates a memory Th2 cell response in the lung. The focus of this new study on the role of lung-resident memory Th2 cells in orchestrating the recall response to allergen in the lung, including the recruitment and activation of circulating Th2 cells, is a natural, timely and exciting extension of the investigators' ongoing Allergen Challenge Protocol. Type: Interventional Start Date: May 2019 |
Phenotyping Asthma for Bronchial Thermoplasty
Massachusetts General Hospital
Severe Asthma
This study will evaluate a new imaging technology, called optical coherence tomography (OCT)
to examine the asthmatic airways before and after bronchial thermoplasty, which is a new
treatment option for severe asthmatic patients. The aim of this study is to learn more about... expand
This study will evaluate a new imaging technology, called optical coherence tomography (OCT) to examine the asthmatic airways before and after bronchial thermoplasty, which is a new treatment option for severe asthmatic patients. The aim of this study is to learn more about how airways respond to this new treatment. In the future the investigators hope OCT will aid clinicians in the initial assessment, management and long-term follow up of patients receiving bronchial thermoplasty. Type: Observational Start Date: May 2021 |
Nivolumab and Ipilimumab and Radiation Therapy in MSS and MSI High Colorectal and Pancreatic Cancer
Massachusetts General Hospital
Microsatellite Stable Colorectal Cancer
Pancreatic Cancer
MSI High Colorectal Cancer
This research study is studying a combination of drugs with radiation therapy as a possible
treatment for Microsatellite Stable Colorectal Cancer, Pancreatic Cancer, or MSI High
Colorectal Cancer.
The interventions involved in this study are:
- Nivolumab... expand
This research study is studying a combination of drugs with radiation therapy as a possible treatment for Microsatellite Stable Colorectal Cancer, Pancreatic Cancer, or MSI High Colorectal Cancer. The interventions involved in this study are: - Nivolumab - Ipilimumab - Radiation Therapy Type: Interventional Start Date: May 2017 |
Phase 1 Study of RBN-2397, an Oral PARP7 Inhibitor, in Patients With Solid Tumors
Ribon Therapeutics, Inc.
Solid Tumor, Adult
RBN-2397 inhibits PARP7, an enzyme that is switched on by cancer stresses, such as the toxins
in cigarette smoke. Cancer cells use PARP7 to hide from the immune system by stopping the
cell from sending a signal (Type 1 interferon) that tells the immune system that something is... expand
RBN-2397 inhibits PARP7, an enzyme that is switched on by cancer stresses, such as the toxins in cigarette smoke. Cancer cells use PARP7 to hide from the immune system by stopping the cell from sending a signal (Type 1 interferon) that tells the immune system that something is wrong and to kill the cell. RBN-2397 has been shown in animal studies to inhibit tumor growth and also shuts down the "don't kill me" signal the tumor is sending to evade the immune system. As a PARP7 inhibitor RBN-2397 is different from drugs inhibiting PARP1, PARP2 and PARP3 enzymes which are approved for the treatment of certain ovarian and breast cancers. The primary purpose of this study is to determine the maximum tolerated dose (MTD) of orally administered RBN-2397 in patients with advanced or metastatic solid tumors. This study will also evaluate the safety and tolerability of RBN-2397, examine the pharmacokinetics (PK) (measure how the body absorbs, breaks down and eliminates RBN-2397) and investigate whether it has antitumor activity in solid tumor cancers. Type: Interventional Start Date: Aug 2019 |
Translumbosacral Neuromodulation for FI
Augusta University
Fecal Incontinence
Fecal Incontinence (FI) affects 40 million Americans, predominantly women and elderly. It is
a major health care burden, significantly impairs quality of life and psychosocial function.
FI is characterized by multifactorial dysfunction including lumbosacral neuropathy, anorectal... expand
Fecal Incontinence (FI) affects 40 million Americans, predominantly women and elderly. It is a major health care burden, significantly impairs quality of life and psychosocial function. FI is characterized by multifactorial dysfunction including lumbosacral neuropathy, anorectal sensori-motor dysfunction, and abnormal pelvic floor-brain innervation. A critical barrier to progress in the treatment of FI is the lack of RCTs, absence of mechanistically based non-invasive therapies that modify disease, and a lack of understanding on how treatments affect pathophysiology of FI. Consequently, most current remedies remain ineffective. Our long-term goal is to address the problem of lack of effective treatments for FI by investigating treatments that modulate neuronal perturbations and thereby improve sensory and motor control, and to understand the neurobiologic basis of these treatments. Our central hypothesis is that a novel, non-invasive treatment consisting of Translumbosacral Neuromodulation Therapy (TNT), using repetitive magnetic stimulation, will significantly improve FI in the short-term and long-term, by enhancing neural excitability and inducing neuroplasticity. Our approach is based on compelling pilot study which showed that TNT at 1 Hz frequency, significantly improved FI, by enhancing bidirectional gut- brain signaling, anal sphincter strength and rectal sensation compared to 5 or 15 Hz. Our objectives are to 1) investigate the efficacy, safety and optimal dose of a new treatment, TNT, in a sham controlled, randomized dose-dependent study in 132 FI patients; 2) determine the mechanistic basis for TNT by assessing the efferent and afferent pelvic floor-brain signaling, and sensori-motor function; 3) identify the durability of treatment response and effects of TNT, and whether reinforcement TNT provides augmented improvement, by performing a long-term, sham controlled randomized trial. Our expected outcomes include the demonstration of TNT as a durable, efficacious, safe, mechanistically based, non-invasive, and low risk treatment for FI. The impact of our project includes a novel, disease modifying, non-invasive treatment, a scientific basis for this treatment, and improved understanding of the pathophysiology of FI and how TNT modifies bidirectional gut and brain axes and anorectal function. Ultimately, the knowledge generated by this project will provide new avenues for the development of innovative, evidence-based therapies for FI. Type: Interventional Start Date: Jun 2019 |
Effect of Theophylline in Pseudohypoparathyroidism
Massachusetts General Hospital
PHP Ia
PHP IB
Php1C
The study evaluates the effect of theophylline in 100 subjects with Pseudohypoparathyroidism.
expand
The study evaluates the effect of theophylline in 100 subjects with Pseudohypoparathyroidism. Type: Interventional Start Date: Nov 2019 |
Proton Craniospinal Irradiation With Bone Sparing to Decrease Growth Decrement From Radiation
Massachusetts General Hospital
Brain Tumor
This research study is studying proton radiation as a possible treatment for brain tumor that
requires radiation.
The radiation involved in this study is:
-Proton Radiation
expand
This research study is studying proton radiation as a possible treatment for brain tumor that requires radiation. The radiation involved in this study is: -Proton Radiation Type: Interventional Start Date: Jan 2018 |
Proton or Photon RT for Retroperitoneal Sarcomas
Massachusetts General Hospital
Retroperitoneal Sarcoma
This research study is a Phase I clinical trial. Phase I clinical trials test the safety of
an investigational intervention. Phase I studies also try to define the appropriate dose of
the investigational therapy to use for further studies. "Investigational" means that the... expand
This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational intervention. Phase I studies also try to define the appropriate dose of the investigational therapy to use for further studies. "Investigational" means that the intervention is still being studied and that research doctors are trying to find out more about it. Retroperitoneal sarcomas are soft tissue tumors located at the far back of the abdomen. Typically, patients with retroperitoneal sarcomas either have surgery for the removal of their tumors alone, or have their tumors removed, followed by standard radiation therapy, or have pre-operative radiation followed by surgery. When conventional radiation therapy is delivered after surgery, it can damage normal tissue. In this study, you will undergo proton beam radiation therapy or IMRT before undergoing surgery for the removal of your tumor. Proton radiation and IMRT are FDA approved radiation delivery systems. Protons are tiny particles with positive charge that can be controlled to travel a certain distance and stop inside the body. In theory, this allows better control of where the radiation dose is delivered as compared to photons. Since proton radiation is more targeted, it may help to reduce unwanted side effects from radiation. In this study, a standard dose of radiation will be given to the majority of the tumor, while a simultaneously integrated boost of additional radiation will be given to certain areas of the tumor identified as higher risk. This means that a higher radiation dose will be given to the higher risk areas of the tumor. The purpose of this study is to determine the highest dose of radiation therapy with protons or IMRT that can be delivered safely in patients with retroperitoneal sarcomas and the effectiveness of proton beam radiation therapy as an intervention for patients with retroperitoneal sarcomas. Type: Interventional Start Date: Dec 2012 |
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