Clinical Trials

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

There will be a number of areas targeted for proton therapy research - including pediatric malignancies, eye malignancies and disorders, central nervous system, head and neck, urological, pulmonary, sarcoma, and breast cancers. Each targeted area will have a team leader responsible for protocol development, patient entry and treatment on protocol, data monitoring, and reporting of results. To ensure that data are monitored regularly, a quarterly report will be required that includes the number of patients treated, plus ongoing analysis of whatever endpoints are pertinent, which will be given to the medical director who will summarize the experience for the Board of Directors of the UF Proton Therapy Institute.

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

Sarcoma
Prostate Cancer
Pituitary
Head and Neck Cancer
Lung Cancer
Pancreatic Cancer
Lymphoma
Chordomas and/or Chondrosarcomas
Outcome Tracking Project
Skin
Pediatric

Prostate Cancer

1st Study title:
UF Proton Therapy Institute 0702 - PR04: A Phase II Study of Hypofractionated Image Guided Proton Radiation Therapy for Low and Intermediate Risk Adenocarcinoma of the Prostate

Principal Investigator:
Randal Henderson, MD

Why is this study being done?
Our purpose in this trial is to give a shorter course (5 1/2 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 (total dose of radiation is divided into large doses - for a smaller 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 week course of hypofractionated image-guided proton radiation on you and your cancer.

2nd Study title:
UFPTI 0703-PR05: A Phase II Study of Proton Based Radiation Therapy with Elective Pelvic Nodal Irradiation, Concomitant Docetaxel, and Adjuvant Androgen Deprivation for High Risk Prostate Adenocarcinoma

Principal Investigator:
Nancy P. Mendenhall, MD

Why is this study being done?
The purpose of this study is to see what effects, good and/or bad, image guided proton based radiation combined with low dose chemotherapy and hormonal therapy has on you and your cancer.

3rd Study title:
UFPTI 0902-PR06: Postoperative or Salvage Radiotherapy for Node Negative Prostate Cancer Following Radical Prostatectomy

Principal Investigator:
Randal H. Henderson, MD

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.

Proton treatment will be given to the prostate bed area in patients at high risk of developing a local recurrence in the future and in patients who have already developed a local recurrence. This will include patients with a rising PSA and no evidence of spread of the cancer elsewhere in the body.

The pelvic lymph nodes will also be treated with conformal x-ray photon treatment in patients who have a high likelihood of cancer involving those nodes.

Some patients may also receive hormone therapy for 2 years, starting 2 months prior to radiation.

Pituitary

Study title:
UF Proton Therapy Institute 0701-PI01: Clinical Outcomes Study of Proton Radiation Therapy for Pituitary Adenoma

Principal Investigator:
Robert Malyapa, MD, PhD

Why is this study being done?
The purpose of this study is to collect and analyze the information pertaining to the tumor response and side effects from proton radiation treatment.

Pancreatic Cancer

1st Study title:
UF Proton Therapy Institute 0609-PC01: A Study Using Photon/Proton Beam Radiation Therapy and Chemotherapy for Unresectable Carcinoma of the Pancreas

Principal Investigator:
Bradford S. Hoppe, MD

Why is this study being done?
The purpose of this study is to find out what effects proton radiation and chemotherapy has on you and your pancreatic cancer.

2nd Study title:
UF Proton Therapy Institute 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.

Chordomas and/or Chondrosarcomas

Study title:
UF Proton Therapy Institute 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:
Robert Malyapa, MD, PhD

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 beam radiation has on you and your cancer.

Lymphoma

Study title:
UF Proton Therapy Institute 0806 – HL01: Improving the therapeutic ratio by using Proton Beam Radiation Therapy for patients with stage IA-IIIBX (bulky/non-bulky) Hodgkin lymphoma involving the mediastinum following standard chemotherapy

Principal Investigator:
Bradford S. Hoppe, MD

Why is this study being done?
The purpose of this study is to look at the role of proton therapy in reducing treatment related side effects.

Head and Neck Cancer

1st Study title:
UF Proton Therapy Institute 0605- NP01: A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Carcinoma of the Nasopharynx

Principal Investigator:
Robert Malyapa, MD, PhD

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 beam radiation has on you and your cancer.

2nd Study title:
UF Proton Therapy Institute 0601 - OP01: A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Oropharyngeal Cancers

Principal Investigator:
Robert Malyapa, MD, PhD

3rd Study title:
UF Proton Therapy Institute 0604 - SI01: A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Cancers of the Nasal Cavity and/or Paranasal Sinuses

Principal Investigator:
Robert Malyapa, MD, PhD

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.

Sarcoma

1st Study title:
UF Proton Therapy Institute 0803-SA02: A Pilot Study Investigating Neoadjuvant Temozolomide-based Proton Chemoradiotherapy for High-Risk Soft Tissue Sarcomas

Principal Investigator:
Daniel J. Indelicato, MD

Why is this study being done?
The goal of this study is to evaluate temozolomide and radiation combination treatment intended to increase the chance of curing your sarcoma and decrease the side effects of treatment.

This study will also look at the tumor tissue that was removed during your initial biopsy and your final surgery for information that may help to treat soft tissue sarcoma in the future. In addition we may analyze a sample of your blood drawn prior to starting treatment.

2nd Study title:
UF Proton Therapy Institute 0805-SA03: A Pilot Study Investigating Preoperative Proton Radiotherapy for Retroperitoneal Sarcoma

Principal Investigator:
Daniel J. Indelicato, MD

Why is this study being done?
The goal of this study is to evaluate radiation treatment intended to increase the chance of curing your sarcoma and decrease the side effects of treatment.

This study will also look at the tumor tissue that was removed during your initial biopsy and your final surgery for information that may help to treat retroperitoneal sarcoma in the future.

Skin

Study title:
UF Proton Therapy Institute 0606- SK01: A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Carcinoma of the Skin of the Head and Neck with Perineural Invasion

Principal Investigator:
Robert Malyapa, MD, PhD

Lung Cancer

1st Study title:
UF Proton Therapy Institute 0802-LU02: A Phase II Trial of 3 Dimensional Proton Radiotherapy with Concomitant Chemotherapy for Patients with Initially Unresectable Stage III Non-Small Cell Lung Cancer

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 at a higher tumor dose (and lower normal surrounding lung dose) combined with standard chemotherapy has on you and your lung cancer. The dose you receive to the tumor will be higher than the standard dose. This may be able to increase the control of your tumor. Due to the accuracy of radiation given with protons, the dose to the normal lung tissue that surrounds the tumor will be lower than standard. This may be able to reduce the frequency and severity of the usual radiation side effects.

2nd Study title:
UF Proton Therapy Institute 0901 - LU03: Hypofractionated, Image-Guided Radiation Therapy with Proton Therapy for Stage I Non-Small Cell Lung Cancer

Principal Investigator:
Bradford S. Hoppe, MD

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.

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 Proton Therapy Institute

Principal Investigator:
Daniel J. Indelicato, MD

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.

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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:
Robert B. Marcus, Jr., 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.