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Clinical Trials & Registry Study

Through Winship, we are proud to offer clinical trials which provide our patients with access to cutting-edge care that is often not available elsewhere. We are dedicated to advancing cancer care through groundbreaking research in new ways to prevent, diagnose and treat diseases.

Clinical Trials

You may be eligible to participate in proton therapy clinical trials at the Emory Proton Therapy Center. Clinical trials are a form of research designed to help answer specific questions about your disease. Some trials allow patients access to novel treatments that are not yet available through standard clinical practice. Other trials compare new approaches to surgery, drug therapies, or radiation therapy. Many trials also evaluate the quality of life of patients with cancer.

During consultation, your physician will discuss any clinical trials that you may be eligible to participate in, and discuss the purpose, risks, and potential benefits of the trial.

Participation in proton therapy clinical trials is voluntary. Patients enrolled in clinical trials often receive extra care coordination and attention from the clinical trials staff. Participation in clinical trials can also help researchers find better treatments for others in the future, just as today’s patients benefit from the advancements in treatment that were made in past clinical trials.

For more information on participating in a proton therapy clinical trial, speak with your oncologist. All active proton therapy clinical trials can be found here. 

Registry Study

All patients are asked to participate in our multi-institutional registry study. Participation in the Emory proton registry study allows us to maintain periodic long-term contact after treatment ends, even if you are not able to return in person. Working with other proton therapy centers across the country, we can better understand the benefits of proton therapy in different diseases, develop additional evidence that supports the value of proton therapy in different conditions, and help us make better decisions about the type of treatments we use on future patients.

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Proton Therapy Clinical Trials

Randomized Clinical Trial Comparing Proton Beam Radiation Therapy with Transarterial Chemoembolization for Hepatocellular Carcinoma: Results of an Interim Analysis

This randomized clinical trial was conducted in patients with hepatocellular carcinoma who were candidates for liver transplantation. Patients were randomized (flip of a coin) to receive either proton therapy or transarterial chemoembolization (TACE) to control the tumor while waiting for transplant. While TACE was considered a standard treatment for patients with hepatocellular carcinomas, the trial was designed to determine whether non-invasive proton therapy may be superior. The trial is not yet complete, but this interim analysis showed a trend toward improved 2-year local tumor control (88% vs 45%) for proton therapy versus TACE. Patients treated with proton therapy were less likely to have an unplanned hospitalization after treatment.

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A Prospective Phase II Randomized Trial of Proton Radiotherapy vs. Intensity Modulated Radiotherapy for Patients with Newly Diagnosed Glioblastoma

In this small randomized phase II clinical trial, patients with glioblastoma were randomly (flip of the coin) assigned to receive either x-ray or proton radiation delivered together with the drug temozolomide. Compared to those assigned to x-rays, patients treated with proton therapy had a statistically lower rate of fatigue (24% vs. 58%) and on average had fewer toxicities during treatment. The study was not designed to evaluate and did not show a difference in outcome, and there was no significant difference in the average time until patients experienced a cognitive decline. This may be related to the unfortunate poor prognosis of glioblastoma, and suggests patients with more favorable types of glioma with longer survival time may be more likely to benefit from proton therapy.

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Phase II Study of Proton Beam Radiation Therapy for Patients With Breast Cancer Requiring Regional Nodal Irradiation

In this phase II clinical trial, 70 women with breast cancer who had undergone surgery and required radiation to the breast or chest wall and nearby (regional) lymph nodes were treated using proton therapy. Nearly all the women had left sided breast cancer, where it can be hard to protect the heart from unnecessary radiation when using x-ray based radiation techniques. Before and after proton therapy, women underwent a heart test called an echocardiogram as well as bloodwork to look at markers of heart strain to see if the proton radiation had any effect on the heart. The study found that 5-years after treatment, the chance of local breast cancer recurrence was less than 2%. There were no serious toxicities of lung inflammation and no changes in bloodwork or other tests to suggest any adverse effect on the heart.

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Clinical outcomes of image-guided proton therapy for histologically confirmed stage I non-small cell lung cancer

In this prospective phase II clinical trial, 55 patients with early- stage (Stage I, T1a or T1b) non-small cell lung cancer were treated with proton therapy. Thirty-four patients were candidates for removal by surgery but declined that option in favor of proton therapy as a non-invasive treatment. The remaining patients were not medically fit for surgery. At 3 years post-t treatment, the likelihood of treated tumor control after proton therapy was 96%. There were no serious (high grade) side effects noted during or after treatment.

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