Radiation Oncology

Clinical Trials and Research

Appointment New Patient Appointment or 214-645-8525

As one of the top academic medical centers in the country and the only National Cancer Institute-designated cancer center in North Texas, we lead and participate in a number of clinical trials aimed at improving the outcomes of patients with cancer. The Department of Radiation Oncology enrolls approximately 200 new patients in clinical trials each year. 

Program Overview

Clinical trials are critical in developing new therapies for cancer and can mean having access to new medication, groundbreaking research, and additional clinical care. Our clinical trials team is comprised of radiation oncologists, radiation biologists, clinical research coordinators, quality assurance coordinators, and clinical data specialists. 

If you’re interested in a clinical trial, please talk to your doctor or call 214-645-8525.

Clinical Trials by Disease Site

Dr. Hannan - Research Lab

Therapeutic

STU 052018.052 (GammaPod Boost) Tumor Bed Boost Using a Breast-Specific Radiosurgery Device, the GammaPod: Registry Study and Evaluation of Quality of Life with Development of Sizing Nomogram. Learn about the GammaPod.

STU 2018.0236 (Tailor RT) A Randomized Trial of Regional Radiotherapy in Biomarker Low-Risk Node-Positive Breast Cancer.

STU-2024-0561 (RAPS) Precision Medicine in Action: Phase II Trial of Response Adaptive Ablative Pre-Operative SPBI (RAPS) and Non-Operative Microbubble-Ultrasound-Guided Sentinel Lymph Node Biopsy in Patients with Early-Stage ER+ Breast Cancer.

Therapeutic

STU 122016.064 (Neurocog. Decline) Phase I/II Trial to Determine the Neurocognitive Decline in Patients with Multiple (>6) Brain Metastases Treated with Distributed Stereotactic Radiosurgery.

Therapeutic

STU 2020.1394 (Rectal PULSAR) Phase I Trial of Ultra-Fractionated Adaptive Radiotherapy, Chemotherapy and Selective Omission of Surgery for Locally Advanced Rectal Cancer.

STU 2024-0601 (ULTRAS) Ultra-High-Dose Radiation for Liver Metastasis Using MR-Guided Treatment with Stereotactic Ablative Single-Fraction (ULTRAS): Phase III Randomized Controlled Trial.

Therapeutic

STU 2021.1091 (NRG-GU010) Parallel Phase III Randomized Trial of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensificiation and Intensification Clinical Trial Evaluation (GUIDANCE).

STU 2023.0566 (PULSAR PROPhET) Phase 1B Study of Personalized Ultrahypofractionated Stereotactic Ablative Radiotherapy of High-Risk PROstate Cancer Guided by PET PSMA (68Ga PMSA-11; Ilucix) Response.

STU 2024.0024 A Study of a Non-Significant Risk (NSR) Device: [68Ga]-PSMA-11 (Illuccix) as a BgRT BioGuide on the RefleXion X1 System in Patients Already Undergoing Diagnostic PET PSMA Imaging.

STU-2024-0919 (SPARK) STING Agonist and Personalized Ultra-Fractionated Stereotactic Adaptive Radiotherapy in Combination with Checkpoint Inhibition for Patients with Metastatic Kidney Cancer.

STU 2025-1220 (RANGER) Phase II Trial of PSA Response-based Androgen Deprivation Therapy and Nodal Coverage for Prostate Cancer Early Salvage Radiotherapy.

Therapeutic

STU 2021.0787 (Cervical PULSAR) A Safety Lead-in Single Arm Phase II Study for Image-Guided Ultrafractionated Radiation Therapy for Treatment of Metastatic Cervical Cancer.

STU 2021.0852 Daily Adaptive External Beam Radiation Therapy in the Treatment of Carcinoma of the Cervix: A Phase II Trial of an Individualized Approach for Intestinal Toxicity Reduction (ARTIA-Cervix).

Therapeutic

STU 2023.0715 (G-FORCE) Phase II Randomized Study of Glottic Larynx Hypofractionated Radiotherapy Versus Conventional Radiotherapy.

STU-2024-0603 (INVERT) Prospective Phase II Randomized Trial of Involved Nodal Versus Elective Neck RadioTherapy.

STU-2024-0171 (KEVLAR) A Randomized Placebo-Controlled Trial of Two Schedules of RRx-001 for the Attenuation of Severe Oral Mucositis in Patients Receiving Concomitant Chemoradiation for the Treatment of Locally Advanced Squamous Cell Carcinoma of the Oral Cavity or Oropharynx.

Therapeutic

STU 022015.069 (JoLT-Ca/STABLEMATES) A Randomized Phase III Study of Sublobar Resection (SR) versus Stereotactic Ablative Radiotherapy (SAbR) in High-Risk Patients with Stage I Non-Small Cell Lung Cancer (NSCLC), the STABLEMATES Trial. Learn more about the JoLT-CA/STABLEMATES trial.

STU-2024-1215 Feasibility Study of Personalized Ultra-fractionated Stereotactic Ablative Radiotherapy (PULSAR) for Cancers of the Central Lung.

Multidisciplinary

Non-Therapeutic

STU2021.0529 Registry Study to Evaluate the Clinical and Dosimetric Outcomes of Cancer Patients' Adaptive Radiation Therapy (ART).

STU 072010.098 Tissue Procurement and Outcome Collection for Radiotherapy-Treated Patients.

STU 2021.0206 Volunteer Scanning for Testing, Evaluating, and Enhancing 1.5T MRI Systems Dedicated to Radiation Treatment Planning and MRI-Guided Radiation Therapy.

STU 2019.1390 Tissue Procurement and Outcome Collection for Cancer Patients with and without Cachexia.

Tissue Research and Outcomes Collection

Neil Desai, M.D., M.H.S., Associate Professor of Radiation Oncology and Director of Clinical Research; Brianna Moore, B.S., Research Assistant I; and Ryan Lee, B.S., Research Assistant I, discuss a study collecting radiation oncology patient biospecimens that are stored in an electronic database, allowing our team to explore genetic variations in cancers and patients with the ultimate goal of analyzing how they contribute to outcomes.

To learn more, visit clinicaltrials.gov. If you're interested in participating, please speak to your physician.

Frequently Asked Questions

Dr. Aguilera - Research Lab

A clinical trial is a research study that is conducted in a medical setting such as a clinic or hospital. It usually involves the testing of a new medication, treatment, or device that is not yet approved by the U.S. Food & Drug Administration (FDA) for routine use.

The purpose of a clinical trial is to find out if a new medical treatment is safe and effective. All medications and treatments in use today were first shown to be effective through clinical trials. New and better treatments for cancer will be discovered only through the continued support of patients who participate in clinical trials.

The Department of Radiation Oncology at UT Southwestern Medical Center is a leader in developing new therapies for patients through clinical trials. It is our priority to ensure scientific integrity, privacy, safety, and ethical conduct in all clinical trials.

Patients of the Department of Radiation Oncology may be eligible to participate in a clinical trial. A patient's particular health status and disease characteristics determines their eligibility. Patients who qualify for a clinical trial decide, with the advice of their physician, whether to participate in the study. How a treatment will work for a patient in a trial cannot be known ahead of time. Therefore, the patient should be aware of both the risks and benefits of clinical trials before deciding.

Patients are never placed in a clinical trial without their knowledge or permission. All qualified patients involved in clinical trials sign consent forms before the study begins.

Before a new treatment is tested with patients, it is carefully studied for several years in the laboratory and tested for safety. This research identifies the new methods most likely to succeed and, as much as possible, shows how to use them safely and effectively. Then, clinical trials undergo a rigorous approval process both by the FDA and by committees of UT Southwestern physicians.

One of these committees also includes patient advocates to ensure that patients are represented and that their rights are fully considered in each trial situation. Although there is always a possibility that a new treatment will be disappointing, the researchers and physicians who approve a study have reason to believe that it will be as good as, or better than, current treatments.

A randomized clinical trial involves dividing participants at random into separate groups. Each group receives a different treatment. Dividing groups at random means that groups will be more similar and the effects of treatment can be compared more fairly. It is not known which treatment is best at the beginning of the trial.

During informed consent, patients are given important information, including possible risks and benefits of the clinical trial. The clinical research coordinator or physician will explain the study, the procedures involved, and answer any questions patients may have, which will help them decide if they want to take part in the trial. 

In addition, the team will walk through a patient's full medical history and perform a physical exam and lab testing to ensure there are no contraindications for participation in the clinical trial. All clinical trials require a time commitment and study schedules vary depending on the individual study.

Patients should be informed about:

  • The purpose of the study
  • The length of the study and what procedures will be done as part of the research study
  • Potential risks or discomforts that may be associated with these procedures, including additional treatment costs, if any
  • What other treatments are available should a patient decide to not participate in the study

Participating in a clinical trial can have many potential benefits, including:

  • Receiving a new treatment before it’s openly available to others
  • Playing a more active role in care
  • Additional medical care and more frequent health check-ups
  • Helping others get better treatment for their health 

Most trials don’t cost anything for the patient. Each trial is different, but the costs are usually incurred by the trial sponsor and, in part, the patient's insurance company. 

Only a small percentage of our clinical trials use placebos. If the trial a patient is considering will be utilizing placebos, the patient will be informed ahead of time. 

Clinical trials are done with the hope that the new treatment will be as (or more) effective than currently available treatments, but this is not known. By definition, if we are doing a study, it is because we do not know if it is more effective, so there is a chance that it’s less effective than current treatment. Similarly, clinical trials are designed with safety in mind and any known risks are explained in the consent form. However, there may be risks that are not known at the time the study is started.

Yes, a patient can quit the trial at any time for any reason.

Any information obtained in a clinical trial remains confidential and is shared only with those involved in the study unless authorized by the participant. Just like any other medical record, a research record may be inspected by the FDA, other federal regulatory authorities, and other legally authorized parties.

Call our clinical trials information line at 214-645-7322.

Once the trial is over, the clinical trials team analyzes all the data collected. Depending on what they find, they might do more testing by moving onto the next phase of the trial or they may stop testing altogether.