Clinical Trials at the University of Florida 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.

 

Current clinical trials: 

Proton therapy research will focus 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.

Click on the below term to jump down to the correlating trial(s):

 


Breast Cancer

1st Study title:
UFPTI 1419-BR02: Prospective Pilot Study of Early Markers of Radiation-Induced Cardiac Injury in Patients with Left-Sided Breast Cancer Receiving Photon or Proton Therapy

Principal Investigator:
Julie Bradley, MD

Why is this study being done?
You are being asked to take part in this study because you have left-sided breast cancer, and you may have received chemotherapy and will now need radiation therapy. The purpose of this study is to determine if there are changes in heart function following completion of radiation therapy for breast cancer as measured by cardiac magnetic resonance imaging (cardiac MRI) scans.

Contact us for additional Information on this trial.

 

2nd Study title:
Pragmatic Phase III Randomized Trial of Proton vs. Photon Therapy for Patients with Non-Metastatic Breast Cancer Receiving Comprehensive Nodal Radiation: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial

Principal Investigator:
Julie Bradley, MD

Why is this study being done?
You are being asked to take part in this study because you have non-metastatic breast cancer (which means your breast cancer has not spread to other parts of your body), and you will be having radiation therapy as part of your cancer treatment. The purpose of this study is to compare two types of standard radiation therapy (photon radiation and proton radiation) to find out which type of radiation is best for treating your type of breast cancer. We will explore your overall health and quality of life, heart problems and other possible side effects of radiation therapy and healthcare use for the two types of radiation.

Contact us for additional Information on this trial.

 

3rd Study title:
Early Markers of Subclinical Pulmonary Vascular Radiation Toxicity in Breast Cancer

Principal Investigator:
Walter O'Dell, PhD / Julie Bradley, MD

Why is this study being done?
The purpose of this study is to better identify breast cancer patients at high risk for experiencing severe pulmonary toxicity requiring medical intervention, provide a means to identify toxicity early on, and tailor treatment and/or early intervention on a per-patient basis.

Contact us for additional Information on this trial.

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Central Nervous System

Study title:

NRG-BN001: Randomized Phase II Trial of Hypofractionated Dose-Escalated Photon IMRT or Proton Beam Therapy versus Conventional Photon Irradiation with Concomitant and Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma

Local Principal Investigator:
Ronny L. Rotondo, MD, CM, FRCPC

Why is this study being done?
The purpose of this study is to compare a higher radiation dose to the standard dose of radiation. Both groups will receive the standard chemotherapy, temozolomide (Temodar). This study will allow the researchers to better understand whether this higher dose/technique is better, the same, or worse than the standard approach.

Contact us for additional Information on this trial.

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Chordomas and/or Chondrosarcomas

Study title:
UFPTI 0607- CH01: A Clinical Outcomes Protocol of Proton Beam Radiation Therapy for Chordomas and/or Chondrosarcomas of the Base of Skull and/or Spine

Principal Investigator:
Ronny L. Rotondo, MD, CM, FRCPC

Why is this study being done?
The purpose of this study is to collect information from your medical records to see what effects the proton radiation has on you and your cancer.

Contact us for additional Information on this trial.

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Head and Neck Cancer

Study title:

UFPTI 0604 - SI01: A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Cancers of the Nasal Cavity and/or Paranasal Sinuses

Principal Investigator:
Roi Dagan, MD, MS

Why is this study being done?
The purpose of this study is to collect information from the questionnaire and your medical records to see what effects the proton radiation has on you and your cancer.

Contact us for additional Information on this trial.

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Lung Cancer

1st Study title:

UFPTI 0901 - LU03: Hypofractionated, Image-Guided Radiation Therapy with Proton Therapy for Stage I Non-Small Cell Lung Cancer

Principal Investigator:
Bradford S. Hoppe, MD, MPH

Why is this study being done?
The purpose of this research study is to determine if hypofractionated image guided radiation therapy (hypoIGRT) is a good way to treat lung tumors for patients who will not have surgery. HypoIGRT is a general term for a group of techniques that deliver higher daily doses of radiation over a shorter period of time compared with conventional radiation. This is thought to be better than conventional radiation, because it delivers a more lethal dose of radiation to the tumor, uses more precise set up that decreases the amount of your lung and heart exposed to radiotherapy, and is more convenient with treatment being completed within 2-3 weeks compared to the typical 7-8 week course of conventional radiotherapy.

Contact us for additional Information on this trial.

 

2nd Study title:
UFPTI 1116 – LUN005-12:  A Phase I/II Study of Hypofractionated Proton Therapy for Stage II-III Non-Small Cell Lung Cancer

Principal Investigator:
Bradford Hoppe, MD, MPH

Why is this study being done?
This study is being done to see if we can develop a more effective and shorter treatment approach for stage III non-small cell lung cancer.

Contact us for additional Information on this trial.

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Lymphoma

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

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Outcome Tracking Project

Study title:
The University of Florida Proton Therapy Institute (UF Proton Therapy Institute) Outcome Tracking Project (OTP) (The UF Proton Therapy Institute OTP)

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.

Contact us for additional Information on this trial.

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Pancreatic Cancer

Study title:
UFPTI 1510-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.

Contact us for additional Information on this trial.

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Pediatric

1st Study title:
RMS13: Risk Adapted Focal Proton Beam Radiation and/or Surgery in Participants with Low, Intermediate and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy

Local Principal Investigator:
Daniel J. Indelicato, MD 

Why is this study being done?

One goal of this study is to find the most effective treatment with the least amount of therapy that will still cure participants with low-risk rhabdomyosarcoma. We want to know this because although chemotherapy and radiation therapy can cure low-risk rhabdomyosarcoma, they can also cause side effects later in life (late effects). Late effects can include slowing of growth in children, inability to have children (sterility), and causing another cancer to develop. 

We also want to know if adding additional chemotherapy (maintenance chemotherapy) will benefit participants with intermediate risk tumors by delaying or preventing the tumor coming back.

This study also has several other goals:

• In some low-risk participants, find out if giving less chemotherapy and less radiation using protons instead of using traditional (photon) radiation will result in fewer late side effects, but still result in a high cure rate.

• Find out how many participants have their tumor come back (recurrence) and compare the recurrence to the original tumor.

• For some patients who receive surgery, find out if the standard procedure that is currently used to find how this cancer is spread (sentinel lymph node sampling) is effective.

• Learn more about RMS and how it responds to treatment by evaluating tumor tissue and blood.

• Learn more about the side effects of this treatment.

• Compare the ability of proton radiation to photon radiation to spare healthy tissue from receiving radiation.

Contact information: Meghan Brown, Meghan.brown@stjude.org, 901-595-2120

Contact us for additional Information on this trial.

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2nd Study title:
SJMB12: A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma

Local Principal Investigator:
Daniel J. Indelicato, MD 

Why is this study being done?

This research is designed to meet the following main goals:

•To find out if participants with certain types of medulloblastoma can be treated with a lower dose of radiation to the brain and spine.  

•To find out if participants can be treated with a lower dose of the chemotherapy drug cyclophosphamide.  We want to find out if there will be fewer side effects while still achieving the same survival rate as a prior St. Jude study.

•To find out if adding new chemotherapy agents to the standard chemotherapy will improve the survival for intermediate and high risk tumors.

•To find out if adding targeted chemotherapy after standard chemotherapy will benefit participants with higher risk tumors.

 

We also plan to meet a number of other research goals on this study:

•To compare survival of participants treated on this study with a prior St. Jude study.

•To learn more about the side effects of the treatment plans used on this study.

•To learn more about the biology and genetics of medulloblastomas by studying tumor samples in a research laboratory.

•To learn more about the side effects of this treatment on lung, heart, endocrine and brain function.

Contact Information: Kelley Booten, kelley.booten@stjude.org, 901-595-5922

Contact us for additional Information on this trial.

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Prostate Cancer

1st Study title:
UFPTI 0902-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.

Contact us for additional Information on this trial.

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Sarcoma

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

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Skin

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

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