Cancer Treatment Clinical Trials | UF Health Proton Therapy Institute

We believe that, with clinical research, proton therapy will likely become the cancer treatment of choice for many patients. The future of proton therapy depends heavily on clinical research over the coming years. That’s why our primary mission is to conduct clinical research to improve the effectiveness and availability of proton therapy.

Most of the studies conducted at the UF Health Proton Therapy Institute are based on the expectation that at least one outcome of treatment will be significantly better than what can be achieved with traditional radiation therapy.

UF Health Proton Therapy Institute

Current clinical trials:

Proton therapy research focuses on a number of areas and types of cancer, including pediatric malignancies, lymphoma, eye malignancies and disorders, and cancers of the central nervous system, head and neck, breast, pancreas and urological and pulmonary systems – as well as sarcomas.

Breast Cancer

1st Study title:
UFPTI2105-BR05: Improving Breast Radiotherapy Setup and Delivery Using Mixed-Reality Visualization

Principal Investigator:
Perry Johnson, PhD

Why is this study being done?
The purpose of this study is to compare two methods for determining your initial position during your radiation treatment setup. We will compare the standard of care method (how you would be set up if not on this study) with a new method for patient setup. The standard of care method is to align surface marks (tattoos) with ceiling and wall mounted laser systems. The new method is mixed-reality guided radiotherapy (MixRT). With MixRT, we will create and use a hologram (a 3D representation of your body) to position you for treatment. The hypothesis is that the method using MixRT will lead to faster and potentially more accurate patient setups. You will be involved in the study through your first 10 fractions of treatment.

2nd Study title:
UFPTI2107- BR06: Prospective Pilot Cohort Study of Tracking Circulating Tumor DNA in Women Receiving Neoadjuvant Chemotherapy for Breast Cancer

Principal Investigator:
Dr. Raymond Mailhot, MD, MPH

Why is this study being done?
The purpose of this study is to measure changes in the level of circulating tumor DNA (ctDNA) in breast cancer patients at various time points before, during, and after treatment using ctDNA testing.

3rd Study title:
UFPTI2108-BR07: Prospective Trial of Regional Nodal Irradiation for Women with Residual Breast Disease after Neoadjuvant Chemotherapy

Principal Investigator:
Dr. Raymond Mailhot, MD, MPH

Why is this study being done?
The purpose of this study is to evaluate the benefit of receiving nodal radiation after treatment with chemotherapy and surgery for women with breast cancer.

Central Nervous System

There are no Central Nervous System clinical trials open for enrollment at this time.

Chordomas and/or Chondrosarcomas

There are no Chordomas and/or Chondrosarcomas clinical trials open for enrollment at this time.

Head and Neck Cancer

Study title:
UF-HN-004: Risk Adapted De-Intensification of Radio-Chemotherapy for Favorable Prognosis Oropharyngeal Squamous Cell Carcinoma based on HPV subtype and plasma circulating free HPV DNA Level and Clearance Rate.

Principal Investigator:
Roi Dagan, MD, MS

Why is this study being done?
Prior research shows that most people with HPV (Human papillomavirus) -related Oropharyngeal squamous cell carcinoma (OPSCC) have a substance called cell-free HPV DNA (cfHPV DNA) in their blood. In addition to the detectability of cfHPV, this study explores the notion that lower doses of radiation therapy may be as effective as the standard higher doses used presently. This could result in fewer side effects with apparent equal effectiveness against these types of head & neck cancer.

Lung Cancer

There are no lung cancer clinical trials open for enrollment at this time.

Lymphoma

There are no Lymphoma clinical trials open for enrollment at this time.

Outcome Tracking Project

Study title:

The University of Florida Health Proton Therapy Institute (UFHPTI) Radiation Oncology Outcome Tracking Project (RADTRAC-JAX)

Principal Investigator:

Nancy P. Mendenhall, MD

Why is this study being done?

The purpose of this study is to collect information from you and your medical records regarding your disease, your treatment, and your side effects to see what effects the radiation has on you and your disease.

Pancreatic Cancer

Study title:

PAN009-18 (PC04): A Phase II Trial of Escalated Dose Proton Radiotherapy with Elective Nodal Irradiation and Concomitant Chemotherapy for Patients with Unresectable, Borderline Resectable or Medically Inoperable Pancreatic Adenocarcinoma

Principal Investigator:

R. Charles Nichols, MD

Why is this study being done?

The purpose of this study is to find out what effects, good and/or bad, proton radiation combined with chemotherapy and surgery, if performed, has on you and your pancreatic cancer. The goal is improved disease free survival. This study will look at the side effects from the treatment and the quality of your life in relation to your treatment experience. It will also look at how the tumor responds to the combination of treatment with proton radiation.

Pediatric

1st Study title:

Proton and Photon Consortium Registry (PPCR)

Local Principal Investigator:

Daniel J. Indelicato, MD

Why is this study being done?

The purpose of this registry is to collect demographic information (like age, race, gender, zip code) and clinical data (such as diagnosis, treatments and side effects) of pediatric patients who receive proton therapy.

Prostate Cancer

1st Study title:

GU010-18 (PR06): Postoperative or Salvage Radiotherapy for Node Negative Prostate Cancer Following Radical Prostatectomy

Principal Investigator:

Randal H. Henderson, MD, MBA

Why is this study being done?

The purpose of this study is to evaluate the safety and effectiveness of proton radiation therapy for patients who have undergone radical prostatectomy.

2nd Study title:

UF1712-PR11: A Phase II Study of Dose-Escalated Proton-Based Radiation Therapy. Delivered with a Simultaneous Integrated Boost (SIB) to Intraprostatic Tumors (IPT) Visible on Pretreatment Magnetic Resonance Image

Principal Investigator:

Curtis Bryant, MD, MPH

Why is this study being done?

The purpose of this research study is to determine if dose-escalated proton radiation therapy will improve disease control for patients with high-risk prostate cancer while minimizing possible toxicity (side effects).

Previous studies have shown an advantage for delivering higher radiation doses for prostate cancer when looking at overall disease control outcomes. This study features hypofractionation (radiation delivered with a higher daily dose) and an extra boost of radiation to the prostate tumor seen on pretreatment imaging as a method of delivering higher radiation doses for high-risk prostate cancers.

3rd Study title:
RadTox II: Prospective Observational Exploratory Clinical Study to Determine the Assay Cut-Off for the RadTox Test in Prostate Cancer Patients to Predict Gastrointestinal Radiation Toxicity Using Circulating Cell Free DNA Directly from Plasma

Principal Investigator:
Randal H. Henderson, MD, MBA

Why is this study being done?
The purpose of this study is to see if the RadTox test can predict the degree of negative reaction or unwanted side effects a person will have from radiation treatment during the early course of radiation treatment and by comparing the degree of unwanted side effects.

Sarcoma

There are no Sarcoma clinical trials open for enrollment at this time.

Skin

There are no Skin clinical trials open for enrollment at this time.

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