Skip to Content

Proton Therapy Clinical Trials

Clinical trials are research studies in which patients may volunteer to take part. MD Anderson uses clinical trials to find better ways to prevent, diagnose and treat cancer. Doctors use treatment trials to learn more about how to fight cancer.

Clinical trials are part of a long, careful process, which may take many years. First, doctors study a new treatment in the lab. Then they often study the treatment in animals. If a new treatment shows promise, doctors then test the treatment in people. Doctors do this in three to four steps, or phases. Your doctor may offer you a clinical trial as a treatment option.

Below are the current clinical trials offered by the Proton Therapy Center. For more information on clinical trials and how to join one, call toll-free: 1-866-632-4782.

Breast

2009-0818: Assessing the cosmesis & toxicity of partial breast irradiation using PBT
Principal Investigator: Eric A. Strom, M.D, F.A.C.R

The goal of this phase II clinical research study is to find out if receiving a 1-week course of partial breast irradiation (PBI) using proton therapy will cause fewer and/or less severe side effects (such as changes to the appearance of the breast) than a longer course of radiation treatment.

Central Nervous System/Pediatric

2004-0915: Phase II evaluation of proton beam therapy for skull base chondrosarcoma
Principal Investigator: David R. Grosshans, M.D.

The goal of this phase II clinical research study is to learn if proton beam therapy, with or without photon beam radiation therapy, is effective and safe in the treatment of skull base chondrosarcoma.

2010-0489: Phase II study of proton beam radiotherapy for medulloblastoma & pineoblastoma: an assessment of acute toxicity & long term neurocognitive, neuroendocrine & ototoxicity
Principal Investigator: Anita Mahajan, M.D.

The goal of this Phase II clinical research study is to learn about the safety of giving proton beam radiation therapy to the brain and spinal cord in patients 3-25 years old with medulloblastoma or pineoblastoma as well as if proton therapy has fewer short and long-term side effects than a more standard type of radiation therapy.

2013-0097: A prospective Phase II randomized trial to compare intensity modulated proton radiotherapy (IMPT) vs. intensity modulated radiotherapy (IMRT) for newly diagnosed glioblastoma (WHO Grade IV)
Principal Investigator: Paul Brown, M.D.

The goal of this clinical research study is to compare IMRT with IMPT in patients with glioblastoma. Researchers want to learn about cognitive side effects (mental status changes) that may occur, such as memory loss and impaired thinking.

2011-0172: Phase II study of high dose intensity modulated proton radiation treatment +/- surgical resection of sarcomas of the spine, sacrum & base of skull
Principal Investigator: Paul Brown, M.D.

The goal of this Phase II clinical research study is to learn if intensity modulated proton radiation therapy (IMPT) can help to control chordomas of the spine, sacrum, or base of the skull or chondrosarcomas of the spine or sacrum.

Gastrointestinal (GI)

2009-0556: Phase II study of proton beam irradiation for the treatment of unresectable hepatocellular cancer & cholangiocarcinoma
Principal Investigator: Christopher H. Crane, M.D.

The goal of this clinical research study is to learn if proton beam radiation therapy can shrink or slow the growth of the disease in patients with liver cancer. The safety of this treatment will also be studied.

Genitourinary (GU)

2012-1003: Phase II trial of hypo-fractionated proton beam therapy in men with localized prostate adenocarcinoma
Principal Investigator: Thomas Pugh, M.D.

The goal of this clinical research study is to learn if delivering proton therapy in higher doses per treatment may help control prostate cancer just as well as the standard of care treatment. The safety of this treatment will also be studied.

2013-0555: Phase III randomized clinical trial of proton therapy vs. IMRT for low or low-intermediate risk prostate cancer
Principal Investigator: Thomas Pugh, M.D.

The goal of this clinical research study is to study whether men being treated for prostate cancer have the same amount of side effects from either one of two different external radiation treatments: IMRT or PBT. With IMRT, a number of X-ray beams are used to shape the radiation to the prostate. PBT is precise like IMRT, but it uses proton beams instead of x-ray beams. In this research study, we are comparing IMRT to PBT to determine which therapy best minimizes the side effects of treatment.

Head and Neck

2012-0825: Phase III randomized trial of intensity-modulated proton beam therapy (IMPT) versus intensity-modulated photon therapy (IMRT) for the treatment of oropharyngeal cancer of the head and neck
Principal Investigator: Steven J. Frank, M.D.

The goal of this clinical research study is to compare the side effects of 2 radiation treatments for head and neck cancer: intensity modulated photon therapy (IMRT) and intensity modulated proton therapy (IMPT). Participants may also receive chemotherapy along with radiation therapy.

Thoracic

2011-0691: Randomized phase II study comparing stereotactic body radiotherapy (SBRT) with stereotactic body proton therapy (SBPT) for centrally located Stage I, selected stage II & recurrent NSCLC
Principal Investigator: Joe Y. Chang, M.D., Ph.D.

The goal of this clinical research study is to compare 2 types of radiotherapy, stereotactic body photon radiotherapy (SBRT) and stereotactic body proton radiotherapy (SBPT). Researchers would like to compare the side effects, quality of life, and cancer control.

2008-0133: Image guided adaptive conformal photon vs. proton with concurrent chemo for locally advanced NSCLC cancer-pneumonitis & loco-regional recurrence
Principal Investigator: Zhongxing Liao, M.D.

The goal of this phase II clinical research study is to learn if, compared with regular x-ray radiation, proton radiation reduces the risk of developing, treatment-related pneumonitis (TRP) or tumor recurrence (the tumor coming back in the irradiated area after treatment) in patients with lung cancer.

2011-1058: Phase I/II trial of image guided intensity modulated proton therapy (IMPT) & simultaneous integrated boost (SIB) dose escalation to the GTV & concurrent chemo in stage II/III NSCLC
Principal Investigator: Zhongxing Liao, M.D.

The goal of this clinical research study is to learn if the dose of radiation to the tumor but not the surrounding healthy tissue could be increased by using intensity-modulated photon therapy (IMRT) or intensity-modulated proton beam therapy (IMPT).

In Phase I of the study, researchers want to find the highest tolerable dose of IMPT or IMRT that can be given to the tumor. In Phase II, researchers want to learn if IMPT can help to control the disease compared with standard proton therapy when both are combined with standard chemotherapy. In this study, the tumor will receive a higher dose by adjusting the energy and scanning time of the protons or photons, called simultaneous integrated boost (SIB). This newer type of radiation is designed to give a higher than standard dose of treatment to the tumor.

2011-1036: Phase III randomized trial of PBT vs. IMRT for the treatment of esophageal cancer
Principal Investigator: Steven Lin, M.D.

The goal of this clinical research study is to learn how safe and effective proton-beam therapy (PBT) may be in comparison to intensity modulated radiation therapy (IMRT) in combination with chemotherapy in patients with esophageal cancer.

PBT and IMRT are both forms of radiation therapy that are designed to treat a specific area of the body while affecting as little of the surrounding normal tissue as possible. PBT is a newer technology that is designed to further reduce the amount of radiation that affects the surrounding normal tissue.

* Last updated 3/18/14

© 2014 The University of Texas MD Anderson Cancer Center