Clinical Trials at the University of Florida Health Proton Therapy Institute

Confidence Through Clinical Research

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.

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.

Current clinical trials: 

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

 


Breast Cancer

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.

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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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Macular Degeneration

Study title:
UFPTI 1206-EY01: A Pilot Study to Assess the Safety of Proton Therapy for Subfoveal Neovascularization Associated With Age-Related Macular Degeneration

Principal Investigator:
Roi Dagan, MD

Why is this study being done?
The purpose of this study is to determine if Radiation Therapy using Protons can provide effective and safe treatment for subfoveal neovascularization membrane, a condition that causes severe loss of vision in patients with age-related macular degeneration.

Contact us for additional Information on this trial.

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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

1st Study title:
UFPTI 0704-PC02: A Pilot Study Using Neoadjuvant Proton Beam Radiation Therapy and Chemotherapy for Marginally Resectable Carcinoma of the Pancreas

Principal Investigator:
R. Charles Nichols, MD

Why is this study being done?
The purpose of this study is to find out what effects proton radiation combined with chemotherapy and surgery has on you and your pancreatic cancer. This study will look at the side effects from the treatment and the quality of your life in relation to pain. It will also look at how the tumor responds to the combination of treatment with radiation, chemotherapy and surgery.

Contact us for additional Information on this trial.

 

2nd Study title:
UFPTI 1013-PC03: A Phase II Trial of Postoperative Proton Radiotherapy with Concomitant Chemotherapy for Patients with Resected Pancreatic Adenocarcinoma

Principal Investigator:
R. Charles Nichols, MD

Why is this study being done?
To find out what effects, good and/or bad, proton radiation combined with chemotherapy (Gemzar®) has on you and your resected pancreatic cancer.

Contact us for additional Information on this trial.

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Pediatric

1st Study title:
Risk-Adapted Therapy For Children Less Than 3 Years Of Age With Embryonal Brain Tumors, High-Grade Glioma, Choroid Plexus Carcinoma Or Ependymoma (Sjyc07 Protocol)

A joint study conducted by St. Jude Children's Research Hospital and UF Health Proton Therapy Institute

Principal Investigator:
Daniel J. Indelicato, MD – local PI

Why is this study being done?
Radiation therapy is an important part of treatment for brain tumors in children younger than 3 years of age. Past attempts to delay or avoid using radiation therapy in very young children with brain tumors have not been successful. When radiation therapy is not given, the tumor is likely to come back within a year from diagnosis. The goal of delaying radiation therapy was to avoid side effects. Side effects were considered severe in children with medulloblastoma, PNET, ATRT, and similar tumors when the entire brain and spine was treated (craniospinal irradiation). Side effects were of great concern in children with ependymoma and similar tumors even though treatment of only the tumor bed has been the standard. Our recent research protocols suggest that using radiation therapy soon after initial surgery results in better cure rates and that the anticipated side effects are less because newer methods of radiation therapy have been developed.

>> View Extended Description

Contact Annemarie McClellan 901-495-2734 at St Jude Children's Research Hospital for additional Information on this trial

 

2nd Study title:
UFPTI 0903-CN01: A Study of Late Effects After Proton Radiotherapy for Pediatric Tumors of the Brain, Head, and Neck

Principal Investigator:
Daniel J. Indelicato, MD

Why is this study being done?
The purpose of this study is to show a relation between the dose of radiation to normal brain tissue in the child’s brain with late endocrine (pituitary, thyroid, and adrenal glands) effects, auditory (hearing) effects, alopecia (hair loss), and in addition, monitor the quality of life after proton radiation therapy.

Contact us for additional Information on this trial.

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3rd Study title:
RT2CR: A Phase II Trial of Limited Surgery and Proton Therapy for Craniopharyngioma and Observation for Craniopharyngioma after Radical Resection

A joint study conducted by St. Jude Children's Research Hospital and UF Health Proton Therapy Institute

Principal Investigator:
Daniel J. Indelicato, MD – local PI

Why is this study being done?
The main goal of this study is to learn if proton radiation therapy will effectively treat patients with craniopharyngioma brain tumors and reduce side effects compared to more traditional forms of radiation therapy.

This study also has several other goals:

  1. Evaluate and compare the side effects of surgery with proton therapy.
  2. Study problems with sleep after surgery and/or proton therapy.
  3. Learn more about physical performance problems in patients with craniopharyngioma.
  4. Investigate the role of MRI in evaluating the response of the tumor and normal tissue to treatment.
  5. Determine if PET scans will predict which tumors are more likely to grow back after treatment.
  6. Evaluate the ability of PET to confirm the limit of proton therapy dose in normal brain tissue. 
  7. Study the changes in cytokines in blood, markers of inflammation and tumor response after treatment.
  8. Learn more about craniopharyngioma and how it responds to treatment by evaluating tumor tissue and blood.

Contact us for additional Information on this trial.

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4th Study title:
Pediatric Proton Consortium Registry (PPCR): Multi-Center Registry of Pediatric Patients treated with Proton Radiation Therapy

Principal Investigator:
Daniel J. Indelicato, MD 

Why is this study being done?
This research study collects information about pediatric patients with cancer who have been treated with proton radiation therapy. The goal of the Pediatric Proton Registry is to enroll patients 21 years old or younger treated with proton radiation in the United States in order to describe the population that currently receives protons and better evaluate its benefits over other therapies. The information collected from this study will help us and other researchers learn more about proton radiation therapy and allow for collaborative research.
 

Contact us for additional Information on this trial.

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5th Study title:
RMS12: Risk Adapted Focal Proton Beam Radiation and/or Surgery in Participants with Low and Intermediate 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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6th Study title:

ESFT13: Therapeutic Trial for Patients with Ewing Sarcoma Family of Tumor and Desmoplastic Small Round Cell Tumors.

Local Principal Investigator:
Daniel J. Indelicato, MD

Why is this study being done?

One goal of this study is to find out if the treatments on this study will benefit children and young adults with ESFT and DSRCT. We also want to find out what effects (good or bad) two new chemotherapy treatment regimens will have on participants with high risk ESFT and DSRCT. 

This study also has several other goals:

Learn about the effects of this treatment on the heart, lung (if tumor is in the chest), thyroid function, fertility (future ability to have children), body function, and quality of life during and after treatment.

To find out how to better diagnose and treat ESFT and DSRCT by using advanced imaging methods.

To learn more about the side effects of chemotherapy drugs.

To study the effect of this treatment on tumor blood flow.

Contact Information: Dana Hawkins, Dana.hawkins@stjude.org, 901-595-4616

Contact us for additional Information on this trial.

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7th 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.

 

2nd Study title:
UFPTI 1103-PR07: An Expanded Phase II Study of Hypofractionated Dose Intense Image Guided Proton Radiation Therapy for Low and Intermediate Risk Adenocarcinoma of the Prostate

Principal Investigator:
Randal Henderson, MD, MBA

Why is this study being done?
Our purpose in this trial is to give a shorter course (5 ½-6 weeks) of radiation that has as little side effects on normal bladder and rectal tissues as the usual longer course (8 weeks) of radiation, without decreasing the chance of killing prostate cancer cells.

Multiple studies have shown an advantage to higher doses of radiation in the treatment of prostate cancer. Some studies show that a shorter, hypofractionated, course of radiation (radiation delivered with a larger daily dose to a lower total dose) can be used to safely deliver an equivalent killing effect on prostate cancer cells. This study will see the effects (good and/or bad) of a 5 ½-6 week course of hypofractionated image-guided proton radiation on you and your cancer.

Contact us for additional Information on this trial.

 

3rd Study title:
UFPTI 1301-OL01: Phase II Stereotactic Body Radiotherapy (SBRT) and Stereotactic Hypofractionated Radiotherapy (SHRT) for Oligometastatic Prostate Cancer

Principal Investigator:
Roi Dagan, MD, MS

Why is this study being done?
The purpose of this study is to evaluate the outcomes of patients treated with an investigational radiation regimen using Stereotactic Body Radiotherapy (SBRT) or Stereotactic Hypofractionated Radiotherapy (SHRT) for oligometastatic prostate cancer and to establish SBRT/SHRT efficacy (producing a desired result or effect) and safety in this setting.

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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