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, led by Puneeth Iyengar, M.D., Ph.D., 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 214-645-7322.

Clinical Trials by Disease Site

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Breast

Therapeutic

STU 042018-083: GammaPod 5 fxn - Phase II Multi-Center Trial Evaluating 5 Fraction S-PBI (Stereotactic Partial Breast Irradiation) for Early Stage Breast Cancer Using the GammaPod. Learn about the GammaPod.

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 062015-085: SF CK Breast - Phase I Dose Escalation Trial of Single Fraction Adjuvant Stereotactic Body Partial Breast Irradiation (SB-PBI) for Early Stage Breast Cancer.

STU 2018-0236: Tailor RT - A Randomized Trial of Regional Radiotherapy in Biomarker Low-Risk Node-Positive Breast Cancer.

STU 2019-1099 28231 - Single Institution Pilot Study to Detect Radiation-Induced Cardiotoxicity in Left-Sided Breast Cancer Patients Using Hyperpolarized Carbon 13-Based Magnetic Resonance Spectroscopic Imaging.

STU 2019-1183 - A Phase I Dose-Escalation Study of Single Fraction Pre-Operative Partial Breast (S-PBI) for Early Stage Breast Cancer.

Central Nervous System

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.

STU 42011-075: Pituitary - Interstitial Radioactive Iodine Implants for the Treatment of Pan-Invasive Pituitary Macroadenomas.

STU 022015-106: SRS-Dose Escalation - A Phase I Dose-Escalation Study of Stereotactic Radiosurgery for Brain Metastasis without Whole Brain Radiation.

STU 2020-0176: Alliance A071801 Phase III Trial of Post-Surgical Single Fraction Stereotactic Radiosurgery (SRS) Compared with Fractionated SRS (FSRS) for Resected Metastatic Brain Disease.

Non-Therapeutic

STU 042018-100: AVM - Validation Study of Treating Arteriovenous Malformation with Stereotactic Radiosurgery Using CT Angiography for Treatment Planning.

Gastrointestinal

Therapeutic

STU 102014-018: Liver Mets Brachy - A Phase I Therapeutic Dose-Escalation Study Using Percutaneous Image-Guided Navigation for High-Dose Rate Brachyablation of Primary Liver Lesions.

STU 2019-1492: INNATE - Immunotherapy During Neoadjuvant Therapy for Rectal Cancer, a Phase II Randomized Multicenter Trial with and without APX005M, an Anti-CD40 Agonist.

STU 2020-0166: EA2182 - A Randomized Phase II Study of Deintensified Chemoradiation for Early Stage Anal Squamous Cell Carcinoma.

STU 2020-0217: EA2183 - A Phase III Study of Consolidative Radiotherapy in Patients with Oligometastatic HER2 Negative Esophageal and Gastric Adenocarcinoma (EGA).

Genitourinary

Therapeutic

STU 022017-032: NRG-GU002 - Phase II-III Trial of Adjuvant Radiotherapy and Androgen Deprivation Following Radical Prostatectomy with or without Adjuvant Docetaxel.

STU 042016-046: Oligometastatic Renal Cell - Phase II Trial of SAbR for Patients with Oligometastatic Renal Cell Carcinoma.

STU 122016-067: Salvenza - Phase II Randomized Placebo-Controlled Double-Blinded Study of Salvage Radiation Therapy (SRT) Plus Placebo Versus SRT Plus Enzalutamide in Men with High-Risk PSA-Recurrent Prostate Cancer after Radical Prostatectomy (SALV-ENZA).

STU 022015-058: IVC Thrombus - Safety Lead-In Phase II Trial of Neo-Adjuvant SABR for IVC Tumor Thrombus in Newly Diagnosed RCC.

STU 052018-001: Oligo-Progressive - A Phase II Trial of Stereotactic Ablative Radiation Therapy (SAbR) for Patients with Oligo-Progressive Renal Cancer (RCC).

STU 092017-018: POTEN-C - Prostate Oncologic Therapy While Ensuring Neurovascular Conservation (POTEN-C): A Phase II Randomized Controlled Trial of Stereotactic Ablative Body Radiotherapy (SAbR) with or without Neurovascular Sparing for Erectile Function Preservation in Localized Prostate Cancer. Learn more about the POTEN-C trial.

STU 2019-1065: RTOG-3506 - STEEL: A Randomized Phase II Trial of Salvage Radiotherapy with Standard vs Enhanced Androgen Deprivation Therapy (with Enzalutamide) in Patients with Post-Prostatectomy PSA Recurrences with Aggressive Disease Features.

STU 2019-1506: A Phase II Trial of Stereotactic Ablative Radiation (SAbR) for Urothelial Cancer Patients with Progression while on Anti-PD-1/PD-L1 Immunotherapy.

STU 2020-0570: NRG-GU008 - Randomized Phase III Trial Incorporating Abiraterone Acetate with Prednisone and Apalutamide and Advanced Imaging Into Salvage Treatment for Patients with Node-Positive Prostate Cancer After Radical Prostatectomy.

Gynecologic

Therapeutic

STU 2018-0151: AZ Durva/Treme SAbR - Phase I Multi-Center Study of Stereotactic Ablative Radiotherapy (SAbR) in Combination with Durvalumab and Tremelimumab in Patients with Recurrent/Metastatic Advanced Cervical, Vaginal, or Vulvar Cancer.

Head and Neck

Therapeutic

STU 072014-041: NRG-HN001 - Randomized Phase II and Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA).

STU 122017-043: LT-SAbR - A Phase II Trial of Glottic Larynx Stereotactic Ablative Radiotherapy (LT-SAbR) for Early Stage Glottic Larynx Cancer.

STU 022011-213: RTOG-1008 - A Randomized Phase II/Phase III Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors.

STU 2019-0711: INRT-AIR - A Prospective Phase II Study of Involved Nodal Radiation Therapy using Artificial Intelligence-Based Radiomics for Head and Neck Squamous Cell Carcinoma.

STU 2019-0748: IPET - Pilot Study of Interim PET/CT in Patients Treated with Definitive Chemoradiotherapy for Head and Neck Cancer.

STU 2019-1316: RTOG 3507 - KEYSTROKE: A Randomized Phase II Study of Pembrolizumab (KEYTRUDA) Plus Stereotactic Re-Irradiation versus SBRT Alone for Locoregionally Recurrent or Second Primary Head and Neck Carcinoma.

STU 2020-0522: HYPORT-HN - A Randomized Non-Inferiority Phase II Study of Hypofractionated Post-Operative Radiation Therapy for Head and Neck Squamous Cell Carcinoma.

Lung

Therapeutic

STU 042017-024: NRG-LU002 - Maintenance Systemic Therapy Versus Consolidative Stereotactic Body Radiation Therapy (SBRT) plus Maintenance Systemic Therapy for Limited Metastatic Non-Small Cell Cancer (NSCLC): A Randomized Phase II/III Trial.

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 2018-0261: ADRIATIC - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients with Limited Stage Small-Cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy (ADRIATIC).

STU 2019-0858: PACIFIC 4/RTOG-3515 - A Phase III, Randomized, Placebo-Controlled, Double-Blind, Multi-Center, International Study of Durvalumab Following Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients with Stage I/II Non-Small Cell Lung Cancer (PACIFIC-4/RTOG-3515).

STU 2019-1082 - A Phase II Concurrent Durvalumab (MEDI4736) and Radiotherapy Followed by Consolidative Durvalumab (MEDI4736) for Stage III Non-Small Cell Lung Cancer (NSCLC).

Non-Therapeutic

STU 062016-073: Lung SAbR - Investigating Radiation-Induced Injury to Airways and Pulmonary Vasculature in Lung Stereotactic Ablative Body Radiotherapy (SAbR).

STU 022017-075: Vision RT - VisionRT-Based Deep Inspiration Breath-Hold (DIBH) Respiratory Motion Management Strategy, a Pilot Study for Thoracic and Abdominal Tumors Stereotactic Body Radiotherapy.

STU 2019-1390: Tissue Procurement and Outcome Collection for Cancer Patients With and Without Cachexia.

Pediatrics

Non-Therapeutic

STU 2019-1142: Video-based motion detection and prediction for pediatric radiotherapy.

Other

Non-Therapeutic

STU 072010-098: Tissue Procurement - Tissue Procurement and Outcome Collection for Radiotherapy-Treated Patients.

Frequently Asked Questions

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What is a clinical trial?

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.

Who is eligible for a clinical trial?

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.

How is a clinical trial developed?

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.

What is a randomized clinical trial?

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.

What is informed consent?

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.

What information do you need to decide whether or not to enroll in a trial?

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

What are the potential benefits of participating in a clinical trial?

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 

Does it cost money to join a clinical trial?

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. 

How does a patient know if they're receiving treatment or a placebo?

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. 

Are investigational treatments better than currently available ones? Are they safe?

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.

Can a patient quit a clinical trial at any time?

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

Is a patient's information kept private?

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.

How does someone sign up for a clinical trial?

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

What happens when the trial is over?

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.

For more information about our clinical trials and research, please call 214-645-8525 or fill out the form below. 

Enroll in Our Research Registry

Find out how to become a member of our volunteer database and be matched with a research study.

Learn More

From Our Research Department

We're constantly looking for evidence-based methods to improve the safety and efficacy of radiation treatment, as well as enhance the quality of our patients’ lives.

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Clinical Trials – Improving Outcomes

As an academic medical center, UT Southwestern offers clinical trials that give eligible patients access to the newest therapies for multiple conditions.

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