Clinical Trials
Clinical trials are research studies in which patients may volunteer to take part. MD Anderson uses clinical trials to find better ways to prevent, diagnose and treat cancer. Doctors use treatment trials to learn more about how to fight cancer.
The current radiation oncology clinical trials are listed below. Find more information on clinical trials at MD Anderson.
To find other radiation oncology focused clinical trials, please visit:
- Breast Radiation Oncology clinical trials
- Central Nervous System Radiation Oncology clinical trials
- Gastrointestinal Radiation Oncology clinical trials
- Genitourinary Radiation Oncology clinical trials
- Thoracic Radiation Oncology clinical trials
Clinical trials glossary: 12 terms to know
New and better cancer treatments are discovered through clinical trials. By joining one, patients get access to the most cutting-edge treatments.
If you’re considering enrolling in a clinical trial, or if you’re trying to understand the results from one, you may be wondering what words, like Phase, mean. We spoke with Funda Meric-Bernstam, M.D., to learn what you should know to understand clinical trials.
What are clinical trial phases?
Clinical trials happen in four different phases:
- Phase I trials are the first time a drug is being used in humans. They may also explore different dosing schedules or new drug combinations. These trials are looking to determine a safe dosage of the drug, possible side effects and early signs of how well the therapy works. In the initial phase, a clinical trial enrolls about 20 to 50 patients. After a drug dose and schedule is determined, trials may also have expansion cohorts to treat additional patients with specific tumor types.
- Phase II clinical trials include about 20 to 100 patients. They’re studying if a treatment works in treating a specific type of cancer.
- Phase III clinical trials enroll hundreds of patients. They compare the experimental approach with the standard treatment approach to see if the new approach is better.
- Phase IV trials are looking at the long-term benefit of the new drugs as well as any lingering side effects.
Regardless of which Phase you’re considering joining, Meric-Bernstam says there are other terms used to discuss clinical trials. Here’s a glossary of more clinical trial terms you may need to know.
Adverse event – When an enrolled patient experiences a negative change in health, it’s known as an adverse event. It’s important to note that this change may or not be caused by the experimental treatment. Adverse events can be mild, such as skin irritation or fatigue, or they can be more severe, such developing diabetes.
Arm – To determine if a new treatment is more effective than current treatments, Phase II and Phase III clinical trials divide enrolled patients into different groups – called arms – for easy comparison.
Basket trial – Also sometimes called a bucket trial, these clinical trials test a treatment in patients who have different types of cancer but have a common genetic mutation or biomarker that’s determined through genomic profiling.
Eligibility criteria – To create the best conditions for an accurate and unbiased study, clinical trials have guidelines on which patients can and cannot enroll. The purpose of eligibility criteria is to remove the opportunity of chance, which could alter the study’s results. The criteria are different for each study, but they can include age, diagnosis and medical history.
Endpoint – An endpoint is a result of a clinical trial that can be evaluated objectively to show there’s benefit in the experimental treatment. There can be several endpoints in a study. One example is the trial’s response rate, which is the percentage of patients whose tumor shrank or disappeared because of the experimental therapy. Another endpoint is the overall survival rate, which is the percentage of patients who are still alive at a specific time, often five years out from treatment.
Genomic profiling – The goal of genomic profiling is to identify molecular characteristics of a tumor that are driving its growth that can potentially be targeted for treatment with targeted therapies or immunotherapy. Although not every tumor has a known genetic target, Phase I clinical trials are offering some patients this new option.
Performance status – In order to safely participate in a clinical trial, patients need to be healthy enough for everyday activities, such as walking, bathing and getting dressed. You’ll be evaluated on your ability to complete these tasks without someone’s help. This score is known as your performance status.
Placebo – A placebo is a substance that seems like a drug but has no medical benefit. Although they’re sometimes called sugar pills, placebos aren’t always in a pill form. Sometimes used in later-phase clinical trials, a placebo is most commonly combined with the standard treatment, known as the control arm. In the experimental arm, patients may receive an experimental treatment or the standard treatment plus the experimental drug.
Randomization/randomized –The process of randomly assigning patients to different arms of treatment is called randomization. This removes the opportunity for bias or chance. A randomized clinical trial can be blind, which is when patients don’t know to which arm they’ve been assigned, or trials can be double-blind, which is when neither the patients nor the doctors know.
Research biopsy – A biopsy is when a sample of tissue is removed from a tumor for testing. They help with initial diagnosis, but some clinical trials have additional biopsies that are done throughout treatment to better understand how the experimental drug works.
Umbrella trial – The opposite of a basket trial, these trials study patients who have the same type of cancer but with different gene mutations or biomarkers. They’re offered different treatments based on their tumors’ molecular characteristics.
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Radiation Oncology Clinical Trials
Gynecologic Studies
2018-0846
Short Course Adjuvant Vaginal Cuff Brachytherapy (VCB) in Early Endometrial Cancer Compared to Standard of Care (SAVE)
The goal of this clinical research study is to learn if giving higher doses of vaginal cuff brachytherapy (VCB) over a shorter period of time can help to improve the quality of life and symptoms in patients with endometrial cancer. The current standard care is to give lower doses of VCB over a longer period of time.
Researchers think that giving radiation fewer times at a slightly higher dose will help improve patient satisfaction with less side effects, while still helping to control the cancer from returning. This also may be more cost effective.
2018-0899
Talazoparib and Radiation Therapy in Treating Patients With Locally Recurrent Gynecologic Cancers
This phase I trial studies the side effects and best dose of talazoparib in combination with radiation therapy and to see how well they work in treating patients with gynecologic cancers that have come back after previous treatment (recurrent). Talazoparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving talazoparib in combination with radiation therapy may work better in treating patients with gynecologic cancers.
2019-0629
Nelfinavir, Cisplatin, and External Beam Radiation Therapy for the Treatment of Locally Advanced Vulvar Cancer That Cannot Be Removed by Surgery
This phase I trial studies the side effects and best dose of nelfinavir when given together with cisplatin and external beam radiation therapy in treating patients with vulvar cancer that has spread to nearby tissue or lymph nodes (locally advanced) and cannot be removed by surgery. Nelfinavir is an antiviral drug normally used to treat human immunodeficiency virus (HIV). Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Giving nelfinavir, cisplatin, and external beam radiation therapy may work better than giving only cisplatin and external beam radiation therapy in treating patients with vulvar cancer.
2020-0517
Single Fraction or Multi-fraction Palliative Radiation Therapy for the Improvement of Quality of Life in Patients With Metastatic Gynecologic Cancers
This phase II trial studies if a single session of palliative radiation therapy can help improve symptoms of gynecologic cancers that have spread to other places in the body (metastatic) and that affect quality of life as well or more so than multiple sessions (which is the standard of care). Palliative radiation therapy may help patients with metastatic gynecologic cancers live more comfortably.
Researchers also want to learn how radiation affects the immune system and to compare the effects of giving one radiation treatment to giving multiple radiation treatments.
2021-0768
A Radiotracer ([18F]FluorThanatrace) by PET/CT for the Imaging of Breast Cancer
This phase II trial tests whether [18F]FluorThanatrace by positron emission tomography (PET)/computed tomography (CT) can improve imaging techniques in patients with breast cancer undergoing a standard of care biopsy or surgery. [18F]FluorThanatrace is a new radioactive tracer, which is a type of imaging agent that is labeled with a radioactive tag and injected into the body to help with imaging scans. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, [18F]FluorThanatrace. Because some cancers take up [18F]FluorThanatrace it can be seen with PET. CT utilizes x-rays that traverse body from the outside.
CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. [18F]FluorThanatrace by PET/CT may help detect the activity of a certain enzyme in the body that may be related to cancer growth in patients with breast cancer.
2022-0160
Novel Functional Anatomic and Biomarker Indices of Radiation-Induced Female Sexual Toxicities in a Multi-Center Cohort
The purpose of this research study is to understand how radiotherapy and other treatments impact sexual function in cancer patients with female sexual organs. This study may improve our ability to understand why sexual side effects occur after radiotherapy and develop predictive models of these and other side effects that may impact sexual function. The optional biological specimen and ultrasound substudies may enhance our ability to understand these side effects.
The results of this study may lead to improvements in the techniques used to deliver radiotherapy or the development of interventions that will prevent or reduce sexual side effects and improve quality of life for female patients with cancer.
2017-0319
Serial Imaging of the Novel Radiotracer [^18F] FLuorthanatrace ([^18F] FTT) by PET/CTF
This phase I trial studies how well fluorine F 18 fluorthanatrace positron emission tomography (PET)/computed tomography (CT) works in patients with solid tumors. Fluorine F 18 fluorthanatrace is a radioactive tracer, a type of imaging agent that is labeled with a radioactive tag and injected into the body to help with imaging scans. PET/CT uses a scanner to make detailed, computerized pictures of areas inside the body. PET/CT with Fluorine F 18 fluorthanatrace may allow more tumor cells to be found in patients with ovarian, fallopian tube, or primary peritoneal cancer.
Hematologic Malignancies Studies
2011-0283
Radiation Therapy and Rituximab in Treating Patients With Stage I-II Grade 1 or Grade 2 Follicular Lymphoma
This randomized phase I/II trial studies radiation therapy and rituximab in treating patients with stage I-II grade 1 or grade 2 follicular lymphoma. Radiation therapy uses high energy x-rays to kill cancer cells. Immunotherapy with monoclonal antibodies, such as rituximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving radiation therapy with rituximab may kill more cancer cells.
2013-0367
Concurrent Chemotherapy and Radiation Therapy for Newly Diagnosed Nasal NK Cell Lymphoma
The goal of this clinical research study is to learn if radiation therapy and chemotherapy can help control Stage 1 and/or 2 NK cell lymphoma. The safety of the radiation and chemotherapy combination will also be studied. This is an investigational study. Radiation and chemotherapy are FDA approved and commercially available for patients with Stage 1 and/or 2 NK cell lymphoma. The combination of these therapies given at the same time is investigational. Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.
2017-0276
Ultra Low Dose Radiation Therapy in Treating Patients With Mycosis Fungoides
This phase II trial studies how well ultra low dose radiation therapy works in treating patients with mycosis fungoides. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving ultra low doses of radiation may help control the disease and reduce side effects compared to treatment with higher doses.
2018-0348
Ultra Low Dose Radiation Delivered Before or After Chemotherapy-Free Targeted Therapy in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma
This phase II trial studies how well ultra low dose radiation works before or after chemotherapy-free targeted therapy in treating patients with mantle cell lymphoma that has come back or does not respond to treatment. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. Ultra low dose radiation is generally associated with a lower risk of side effects which may allow patients to be able to receive low-dose radiation therapy more often than high-dose radiation therapy. This trial may help doctors learn if giving ultra low dose radiation helps control mantle cell lymphoma and improves response to chemotherapy free targeted therapy.
2020-1150
Outcomes After Chimeric Antigen Receptor Therapy and Radiation Therapy for Hematologic Malignancies
This study collects information on outcomes after chimeric antigen receptor therapy and radiation therapy for hematologic malignancies. Collecting information from patients before, during, and after receiving chimeric antigen receptor therapy or radiation therapy may help doctors to optimize patient selection, dose, timing, and sequencing of these treatments.
2021-0037
Anti-Leukemia Immune Responses After Irradiation of Extramedullary Tumors
This clinical trial assesses how the immune system responds to leukemia tumors after low dose radiation delivered as part of standard of care. The information learned in this study may help them know if adding immunotherapy (a type of treatment that uses the immune system to fight cancer) can be helpful in future leukemia patients receiving radiation.
2021-1139
Phase II Study of Salvage Radiation Treatment After B-cell Maturation Antigen Chimeric Antigen Receptor T-cell Therapy for Relapsed Refractory Multiple Myeloma
This study is a Phase II study to determine the preliminary safety and efficacy of salvage radiation treatment after BCMA CAR-T therapy in subjects with RRMM. The study population will consist of subjects with RRMM previously treated with SOC BCMA CAR-T cell therapy with active disease on the D30+ PET or other imaging scan after CAR-T infusion. Patients who are planned for salvage chemotherapy less than 14 days after completion of radiation treatment will be excluded. Radiation treatment will be to bony or soft tissue plasmacytomas in up to five radiation treatment fields to 10-20Gy (or equivalent dose in 2Gy fractions of 10-21Gy). Final dose, target, and technique are per treating radiation physician discretion within these guidelines. Thirty patients will be enrolled. The co-primary endpoints are objective response rate (ORR) at 6 months and duration of response (DOR) among responders.
2021-0500
Effectiveness of Concurrent Ultra-Low-Dose Total-Skin Electron Beam Therapy and Brentuximab Vedotin Given Quarterly Over 12 Months for Patients With Mycosis Fungoides
To learn if a form of radiation therapy (called ultra-low-dose - total skin electron beam therapy [ULD-TSEBT]) in combination with brentuximab vedotin can help to control mycosis fungoides
2023-0237
A Study of Response Adapted Ultra Low Dose 4 Gy Radiation for Definitive Therapy of Marginal Zone Lymphoma
To learn if response-adapted, ultra-low dose radiation therapy can help to control MZL. This means participates first receive lower does of radiation therapy and then, based on how the disease responds, may receive higher doses after that.
2023-0087
A Phase II Study of Axicabtagene Ciloleucel, an Anti-CD19 Chimeric Antigen Receptor (CAR) T cell Therapy, in Combination With Radiotherapy (RT) in Relapsed/Refractory Follicular Lymphoma
To learn about the safety of a drug called axicabtagene ciloleucel given in combination with radiation therapy to patients with relapsed/refractory FL.
PA18-0791
Neurocognitive Outcomes After Whole Brain Radiation Therapy for Hematologic Malignancies
This study assesses neurocognitive outcomes after receiving radiation therapy to the brain (whole brain radiation therapy) in patients with blood cancers (hematologic malignancies). This may help researchers learn more about the effects of whole brain radiation therapy on memory and thinking in patients with blood cancer.
Melanoma / Sarcoma Studies
2020-0148
Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma (MelPORT)
This phase II trial seeks to determine the role of nodal radiation therapy after sentinel lymph node biopsy (SLNB) for patients with high risk sentinel lymph node positive melanoma who are planned for immunotherapy without completion lymph node dissection. Prior studies of patients with more advanced melanoma have shown nodal radiation therapy can decrease the risk of nodal recurrence but it is not known if this same benefit will be seen in patients with high risk sentinel lymph node positive disease who are planned for immunotherapy.
2021-0789
Hypofractionated Radiation Therapy for Merkel Cell Carcinoma
This phase II trial tests whether hypofractionated radiation works to treat patients with Merkel cell carcinoma. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a fewer number of days than tradition radiation therapy courses for Merkel cell carcinoma. This may be less suppressive of the immune response to tumors and should be helpful for patient convenience.
2022-0330
PRISM: Pre-Operative Radiotherapy and Immunotherapy for Sinonasal Melanoma
The goal of this clinical research study is to learn if pre-operative radiation therapy can help patients with sinonasal melanoma have better outcomes.
Head and Neck Studies
2023-0407- CCTG-HN11 SELECT
SPECT-CT guided elective contralateral neck treatment (SELECT) for patients with lateralized oropharyngeal cancer—A phase III randomized controlled trial.
This study is being done to answer the following question: Is the chance of cancer spreading or returning the same if radiotherapy to the neck is guided, by using a special imaging study called lymph node mapping (lymphatic mapping) Single Photon Emission Computed Tomography (SPECT-CT), compared to the usual treatment when radiotherapy is given to both sides of the neck?
This study is being conducted in order to find out if this approach is as good as the usual approach in controlling the cancer and has fewer side effects and better quality of life. The usual approach for patients who are not in a study is treatment which includes radiotherapy to the tumour and to both sides of the neck to decrease the risk of spread or recurrence of the cancer
2016-1065 (SOAR- HN)
Phase II Randomized Trial of Stereotactic Onco-Ablative Reirradiation versus Conventionally Fractionated Conformal Radiotherapy for Patients with Small Inoperable Head and Neck Tumors (SOAR-HN)
This phase II trial studies how well stereotactic body radiation therapy or intensity modulated radiation/proton therapy works in treating patients with head and neck cancer that has come back. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision.
This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Intensity modulated radiation/proton therapy uses high energy x-rays or protons to kill tumor cells and shrink tumors. It is not yet known whether stereotactic body radiation therapy or intensity modulated radiation/proton therapy may work better in treating patients with head and neck cancer.
2018-1060 VOCAL
Vocal-cord Only vs. Complete Laryngeal radiation (VOCAL): A Randomized Multicentric Bayesian Phase II Trial
This is a multicenter, randomized Bayesian Phase II trial for patients with early stage (T1N0) glottic squamous cell carcinoma treated with radical radiotherapy. The primary objective is to assess the non-inferiority of local control achieved with vocal-cord only radiotherapy (VC-RT) compared to complete larynx radiotherapy (CL-RT) in T1N0 glottic laryngeal squamous cell cancer, measured at 2-years after treatment. Secondary outcomes include overall survival, as well as voice impairment, dysphagia and quality of life, measured respectively by the voice handicap index -10 (VHI-10), the MD Anderson Dysphagia Inventory (MDADI) and the MD Anderson Symptom Inventory- Head and Neck module (MDASI-HN).
Patients will be randomized in a 1:3 ratio to CL-RT (39 patients) and VC-RT (116 patients) arms. There will be stratification by tumor stage (T1a/T1b) and by institution. An interim analysis is planned after the first 55 patients enrolled on the experimental arm have a 6-month follow-up.
2020-0541 NBTXR3
Phase II Study of NBTXR3 Activated by Radiation and Combined with Pembrolizumab for Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Limited PD-L1 Expression or Refractory to PD-1 Blockade
This phase II trial investigates the effect of NBTXR3, radiation therapy, and pembrolizumab in treating patients with head and neck squamous cancer that has come back (recurrent) or has spread to other places in the body (metastatic). NBTXR3 may cause cell destruction when activated by radiation. Radiation therapy, such as stereotactic body radiation therapy, uses special equipment to position a patient and deliver radiation to tumors with high precision.
This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. And 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. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving NBTXR3, radiation therapy, and pembrolizumab may kill more tumor cells.
2016-1023 HYDRA
A Phase I Trial of Stereotactic HYpofractionateD RadioAblative (HYDRA) Treatment of Laryngeal Cancer
To find the highest tolerable dose of stereotactic hypofractionated radioablation (HYDRA) radiation that can be given to patients with laryngeal cancer. The safety of this radiation will also be studied.
2022-0915 LONE-RANGR
Phase II randomized-registry embedded study of lymphoscintigraphy for Oropharyngeal Neoplasms to enable risk-adapted nodal guidance for robotic surgery and/or radiotherapy (LONE-RANGR2)
To test a new radiation treatment design based on where your cancer is located. Most participants with oropharyngeal cancer are treated with radiation to both sides of the neck. However, for participants with oropharyngeal cancer on one side of the neck, receiving radiation to both sides of the neck may result in increased side effects and radiation exposure.
This study is testing the safety and effectiveness of an approach that involves radiation to only one side of the neck in an effort to reduce the overall amount of radiation given and decrease the amount of side effects you may experience.