Medical College of Wisconsin Radiation Oncology Clinical Trials

Study Short Title: SRS-GK-BRAIN-METAST
Study Design: This is a single-arm, single-center, pilot study in which 10 completed patients with one to four brain metastases diagnosed on brain MRI within the past 30 days will be evaluated for study eligibility and enrolled as appropriate.
Principal Investigator: Joseph Bovi, MD
Phase: Ongoing
Type of Study I: Treatment
Type of Study II: Interventional
Oncology Treatment Group: Central Nervous System

Study Short Title: ONCO-RT
Study Design: This will be a phase II, single-arm, multi-center, pilot study assessing the feasibility and impact of substituting PRDR for standard radiation therapy in the upfront treatment of brain metastases on neurocognitive decline as compared to historical controls. This study will enroll 53 patients with radiographically confirmed solid tumor brain metastases.
Principal Investigator: Lindsay Puckett, MD
Phase: II
Type of Study I: Treatment
Type of Study II: Interventional
Oncology Treatment Group: Central Nervous System

Study Short Title: PRORADGLIO
Study Design: This is a single-arm, single-center phase II study designed to assess the efficacy of pulsed reduced dose-rate radiotherapy in the initial treatment of maximally safely resected glioblastoma. The primary endpoint will be progression-free survival at six months and the study is powered to detect improved PFS of 72% at six months compared with historical control of 50% at six months. Patients with pathologically confirmed GBM who are planned for six weeks of adjuvant chemoradiation followed by six to 12 cycles of adjuvant chemotherapy will be screened and enrolled after surgery. Intention to use TTF/Optune® will also be recorded.
Principal Investigator: Michael Straza, MD
Phase: II
Type of Study I: Treatment
Type of Study II: Interventional
Oncology Treatment Group: Central Nervous System

Study Short Title: SOFT-PRE-OP
Study Design: This study is a prospective, open-label, randomized, parallel, two-arm, phase II clinical trial. Patients meeting the eligibility criteria will be randomized after a minimum of one cycle of induction chemotherapy. These patients will be required to have no biopsy-proven distant disease on repeat staging studies before randomization. Patients who have radiologically equivocal evidence of distant metastatic disease (small lung nodules, or liver lesions that cannot be definitively characterized, etc.) are also eligible for enrollment. Patients with biopsy-proven metastatic disease are not eligible. The total number of patients planned for accrual is approximately 102 patients (51 patients per arm), with 14 additional patients enrolled to account for a roughly 15% drop out rate.
Principal Investigator: William Hall, MD
Phase: II
Study Type I: Treatment
Study Type II: Interventional
Oncology Treatment Group: Gastrointestinal

Study Short Title: Re-DIRICT
Study Design: For each serial OAR, we expect that 10% or less of reirradiated patients will have a Grade 3-5 toxicity. Under this assumption, 15 patients treated at a defined OAR will provide a 90% confidence interval (CI) for the Grade 3-5 OAR toxicity rate with a CI width no larger than 29%. A total of 120 treated patients (15 per OAR) are needed to provide this level of precision for toxicity rates within all 8 OARs (spinal cord, brachial plexus, named vessels, esophagus, duodenum, rectum, proximal bronchus/trachea, liver). For each OAR, the numbers of patients reirradiated and Grade 3-5 toxicities among them will be tabulated. The Grade 3-5 toxicity rate among treated patients will be estimated separately for each OAR using the sample proportion and a 90% Wilson score confidence interval. Only patients who initiate re-irradiation therapy will be included in this analysis.
Principal Investigator: Elizabeth Gore, MD
Phase: II
Study Type I: Treatment
Study Type II: Interventional
Oncology Treatment Group: Multiple Diseases

Study Short Title: MRL-STIM
Study Design: Study Rationale: On each MR acquired on the MR-linac, a series of contours, including the tumor and organs at risk (OAR), will be populated from the planning image to each of these weekly image sets, using an integrated autosegmentation software tool (MIM Software Inc., Cleveland, OH) based on image registration. The contours generated will be edited manually, if necessary. To quantify the intra- and interfractional organ deformation and volume change for each organ, various quantities, including maximum overlap ratio (MOR), dice similarity coefficient (DSC) and the distance of centers of mass (DCOM) will be determined. An adaptive plan will then be generated, using planning software (e.g., Monaco) and delivered to a testing device to verify the dose calculation. This process will be used to determine the clinical feasibility of adapting radiation therapy plans on the MR-LINAC. It is not clear if this process is feasible and achievable on a large scale, and in a variety of tumor sites. Determining this feasibility will be a central task of this proposal. Such understanding will be essential for developing MRI-guided treatment strategies for clinical trials to be executed on the MR-Linac in the future.
Principal Investigator: William Hall, MD
Phase: Ongoing
Type of Study I: Epidemiologic/Observational
Type of Study II: Observational
Oncology Treatment Group: Multiple Diseases

Study Title: Assessment of Intra-and Inter-Fraction Changes in Radiation Therapy
Study Short Title: ELEKTA-MR-LINAC
Study Design: Aims: The goal of this project is to perform an analysis to quantify the intra-fraction, inter-fraction and post-treatment changes in anatomy and imaging features of tumor and surrounding normal organs in radiation therapy. Data in treatment charts including images (e.g., CT, MRI, PET, ultrasound, and x-rays, acquired in the standard radiation treatment) will be reviewed. Major tumor sites including brain, head and neck, thorax, breast, abdomen, pelvis and sarcoma will be studied to determine magnitude of the intra- and inter-fraction and post-treatment changes for each of these tumor sites/types. The dosimetric impacts of these changes will be evaluated using various treatment planning software tools. The CTV-to-PTV margin will be determined from the inter- and intra-fraction variations. The appropriate ART strategy and its theoretical advantages will be demonstrated from the dosimetric data based on adaptive replanning using treatment planning software tools. Methods to optimize imaging acquisition and post-processing for better organ delineation will be investigated.
Principal Investigator: Eric Paulson, PhD
Phase: Ongoing
Type of Study I: Epidemiologic/Observational
Type of Study II: Observational
Oncology Treatment Group: Multiple Diseases

Study Short Title: AR
Study Design: Purpose: This project is being done to develop methods and technologies to evaluate use of Augmented Reality (AR) in patients or physicians in Radiation Oncology. Testing on normal control subjects helps refine our method for patients.
Principal Investigator: Eric Paulson, PhD
Phase: Ongoing
Type of Study I: Other
Type of Study II: Not Applicable
Oncology Treatment Group: Multiple Diseases

Study Title: Recognition of Circulating Tumor DNA in Sarcoma
Study Short Title: CTDNA
Study Design: This is a nonrandomized pilot study to determine the feasibility of collecting and identifying ctDNA and correlating change in ctDNA presence after designated therapies at various time points.
Principal Investigator: Meena Bedi, MD
Phase: Ongoing
Type of Study I: Epidemiologic/Observational
Type of Study II: Observational
Oncology Treatment Group: Sarcoma

Study Title: Evaluating Pre-Treatment Vestibular Physical Therapy Rehab for Patients with Vestibular Schwannomas
Study Short Title: PREHAB-VS
Study Design: The study is a pilot feasibility study. We aim to estimate mean baseline and post-treatment balance scores among VS patients undergoing PREHAB or no PREHAB when managed with either surgery or radiosurgery. These data will be collected to design formally powered future prospective randomized trials.
Principal Investigator: Michael S. Harris, MD
Phase: Ongoing
Type of Study I: Supportive Care
Type of Study II: Interventional
Oncology Treatment Group: Central Nervous System

Study Short Title: MRI-ENHANCE
Study Design: Study Rationale: There are limited studies evaluating real-time adaptive radiation therapy for locally advanced (Stage I–III) rectal adenocarcinoma with the goal of accomplishing organ preservation. We are testing higher doses of radiation therapy, using a novel method of real-time adaptive MRI-based radiation therapy treatment.
Principal Investigator: William Hall, MD
Phase: I/II
Type of Study I: Treatment
Type of Study II: Interventional
Oncology Treatment Group: Gastrointestinal

Study Short Title: HART-HN
Study Design: We propose a pilot Phase I study using a Time-to-Event Continuous Reassessment Methodology (TITE-CRM) to estimate the minimum number of fractions of the HART-HN regimen that may be delivered safely. Patients with resected head and neck cancers found to have intermediate pathologic features warranting adjuvant radiation with no prior history of head and neck radiation and a life expectancy of at least 12 months will be enrolled. Baseline symptom evaluation will be obtained using validated surveys of head and neck cancer patients: the Functional Assessment of Cancer Therapy for the Head and Neck (FACT-HN) and the MD Anderson Dysphagia Inventory for Head and Neck (MDADI-HN). Patients will then undergo treatment using HART-HN and will then be followed for up to 1 year.
Principal Investigator: Musaddiq Awan, MD
Phase: I
Type of Study I: Treatment
Type of Study II: Interventional
Oncology Treatment Group: Head/Neck

Study Short Title: BODY-MRI
Study Design: Purpose: The goal of this pilot study is to develop methodologies to address the challenges facing acquisition of high fidelity MR images for RTP. Specifically, we intend to develop technologies to improve diffusion-weighted imaging (DWI) and dynamic contrast-enhanced (DCE) imaging. In addition, we aim to develop four-dimensional (4D) imaging methods from which estimates of tumor and adjacent OAR motions can be obtained without the use of ionizing radiation.
Principal Investigator: Eric Paulson, PhD
Phase: Ongoing
Type of Study I: Other
Type of Study II: Observational
Oncology Treatment Group: Multiple Diseases

Study Title: Development of Synthetic CT Images for MRI-based Radiotherapy
Study Short Title: SYNTHETIC-CT
Study Design: The purpose of this study is to improve the accuracy of radiation treatment planning and potentially eliminate the need for a CT Simulation exam for radiation treatment planning.
Principal Investigator: Eric Paulson, PhD
Phase: Ongoing
Type of Study I: Epidemiologic/Observational
Type of Study II: Observational
Oncology Treatment Group: Multiple Diseases

Short title: IIT-KERNS-BIOMARKERS-RT
Study Design: The goal of this project is to evaluate separate PRSs for GU and GI toxicity in individuals receiving a standard course of pelvic radiotherapy in which the bladder and/or rectum are organs at risk.
Principal Investigator: Sarah Kerns, PhD, MPH
Phase: N/A
Type of Study I: Basic Science
Type of Study II: Non-interventional longitudinal cohort study
Oncology Treatment Group: Multiple Diseases