What are Clinical Trials?

Clinical trials are research studies with the goal of investigating new ways proton therapy can benefit patients. Each study answers a specific set of scientific questions and explores new treatment standards that may improve how we deliver care.

Clinical trials are conducted in a series of steps called phases. Each phase is designed to answer a separate research question. The phases are:

Phase II Trial

A study to test whether a new treatment has an anticancer effect (for example, whether it shrinks a tumor or improves blood test results) and whether it works against a certain type of cancer.

Phase II/III Trial

A trial to study response to a new treatment and the effectiveness of the treatment compared with the standard treatment regimen.

Phase III Trial

A study to compare the results of people undergoing a new treatment with the results of people undergoing the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into phase III only after a treatment seems to work in phases I and II. Phase III trials may include hundreds of people.

What are Protocols?

For every clinical trial, a protocol, or action plan, is prepared prior to conducting the trial. The protocol describes in detail what will be done in the study, how it will be conducted, and why each part of the study is necessary. Each study has its own rules about who can participate. For instance, some studies need patients with a certain condition, some need healthy people, some need just men or just women, etc.

Clinical Trials

Since the U.S. Food and Drug Administration approved proton therapy to treat patients in 1988, the medical community has conducted research on the use of protons in treating different types of cancer through clinical trials.

Over the years, many patients have volunteered to take part in these clinical trials to help find improvements in fighting cancer with proton therapy. Our site alone has enrolled over 1,200 patients in clinical research studies, and we are 1 of 3 centers that participate in a registry devoted to pediatric proton therapy research.

We offer approximately 14 active research protocols for adults and many more for children to help advance clinical standards for proton therapy.

Breast

  • BRE007-12 Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer: The purpose of this research study is to compare the effects (good and bad) on women and their cancer using proton radiation therapy.
    ClinicalTrials.gov Identifier: NCT01766297
  • UPCC 19115 Pragmatic Randomized Trial of Proton vs. Photon Therapy for Patients With Non-Metastatic Breast Cancer: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial: A pragmatic randomized clinical trial of patients with locally advanced breast cancer randomized to either proton or photon therapy and followed longitudinally for cardiovascular morbidity and mortality, health-related quality of life and cancer control outcomes. Quality of life is the outcome measure for the estimated primary completion date of November, 2020.
    ClinicalTrials.gov Identifier: NCT02603341

Brain/CNS

  • NRG BN001 Dose-Escalated Photon IMRT or Proton Beam Radiation Therapy Versus Standard-Dose Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma: This randomized phase II trial studies how well dose-escalated photon intensity-modulated radiation therapy (IMRT) or proton beam radiation therapy works compared with standard-dose radiation therapy when given with temozolomide in patients with newly diagnosed glioblastoma.
    ClinicalTrials.gov Identifier: NCT02179086
  • NRG BN005 A Phase II Randomized Trial of Proton vs. Photon Therapy (IMRT) for Cognitive Preservation in Patients With IDH Mutant, Low to Intermediate Grade Gliomas: This randomized phase II clinical trial studies the side effects and how well proton beam or intensity-modulated radiation therapy works in preserving brain function in patients with IDH mutant grade II or III glioma.
    ClinicalTrials.gov Identifier: NCT03180502
  • N0577 Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma: This study will be a randomized phase III for patients with newly diagnosed co-deleted 1p/19q anaplastic glioma or high risk low grade glioma. The primary goal is to determine whether patients who receive radiotherapy with concomitant temozolomide (TMZ) followed by adjuvant temozolomide (RT + TMZ --> TMZ) (Arm B) have a marginally better progression free survival (PFS) as compared with patients who receive radiotherapy followed by PCV chemotherapy (RT --> PCV)(Arm A).
    ClinicalTrials.gov: NCT00887146
  • NRG-BN003 Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed by Surgery: This randomized phase III trial studies how well radiation therapy works compared with observation in treating patients with newly diagnosed grade II meningioma that has been completely removed by surgery.
    ClinicalTrials.gov: NCT03180268
  • Pending/coming soon - CCTG CE.7 Stereotactic Radiosurgery Compared With Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5-15 Brain Metastases: The purpose of this research study is to compare the effects (good or bad) of receiving stereotactic radiosurgery (SRS) versus receiving hippocampal-avoidant whole brain radiotherapy (HA-WBRT) plus a drug called memantine, on brain metastases. Receiving SRS could control cancer that has spread to the brain.
    ClinicalTrials.gov: NCT03550391

Esophageal

  • GI006: Phase III Randomized Trial of Proton Beam Therapy (PBT) Versus Intensity Modulated Photon Radiotherapy (IMRT) for the Treatment of Esophageal Cancer: This trial studies how well proton beam radiation therapy compared with intensity modulated photon radiotherapy works in treating patients with stage I-IVA esophageal cancer. Proton beam radiation therapy uses a beam of protons (rather than x-rays) to send radiation inside the body to the tumor without damaging much of the healthy tissue around it. Intensity modulated photon radiotherapy uses high-energy x-rays to deliver radiation directly to the tumor without damaging much of the healthy tissue around it. It is not yet known whether proton beam therapy or intensity modulated photon radiotherapy will work better in treating patients with esophageal cancer.
    ClinicalTrials.gov Identifier: NCT03801876
  • EA2183 Testing the Addition of Radiotherapy to the Usual Treatment (Chemotherapy) for Patients With Esophageal and Gastric Cancer That Has Spread to a Limited Number of Other Places in the Body: This phase III trial studies how well the addition of radiotherapy to the usual treatment (chemotherapy) works compared to the usual treatment alone in treating patients with esophageal and gastric cancer that has spread to a limited number of other places in the body (oligometastatic disease).
    ClinicalTrials.gov: NCT04248452

Head/Neck

  • MDACC 2012-0825 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: The goal of this clinical research study is to compare the side effects of two radiation treatments for head and neck cancer. The two treatments are intensity modulated photon therapy (IMRT) and intensity modulated proton therapy (IMPT). Participants will also receive chemotherapy along with radiation therapy.
    ClinicalTrials.gov Identifier: NCT01893307

Hodgkin Lymphoma

  • S1826 Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma: This randomized phase III trial compares immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic Hodgkin lymphoma.
    ClinicalTrials.gov: NCT03907488

Liver

  • GI003 A Phase III Randomized Trial of Protons Versus Photons For Hepatocellular Carcinoma: The purpose of this study is to determine if overall survival (OS) is different for hepatocellular carcinoma patients treated with protons compared to photons.
    ClinicalTrials.gov Identifier: NCT03186898

Lung

  • RTOG 1308 Comparing Photon Therapy To Proton Therapy To Treat Patients With Lung Cancer: This randomized phase III trial studies proton chemoradiotherapy to see how well it works compared to photon chemoradiotherapy in treating patients with stage II-III non-small cell lung cancer that cannot be removed by surgery.
    ClinicalTrials.gov Identifier: NCT01993810

Pediatrics

  • PPCR 12-103 PPCR-Registry for Pedi Patients Treated With Proton RT: The goal of the Pediatric Proton Consortium Registry (PPCR) is to enroll children 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 data collected from this study will help facilitate research on proton beam radiation therapy and allow for collaborative research.
    ClinicalTrials.gov Identifier: NCT01696721

Prostate

  • GU002-10 Study of Hypo-fractionated Proton Radiation for Low Risk Prostate Cancer: The purpose of this study is to compare the effects (good and bad) on patients with prostate cancer by comparing the standard dose of radiation therapy (44 treatments over 8 1/2 to 9 weeks) with a higher daily dose of radiation (five treatments over 1 to 2 weeks) to see if the effects of the treatments are similar or better.
    ClinicalTrials.gov Identifier: NCT01230866
  • GU003-10 Hypo-fractionated Proton Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer: The purpose of this study is to compare the effects, good and/or bad, of two treatment methods on subjects and their cancer, namely the use of hypofractionated proton therapy (28 treatments) alone to proton therapy with androgen suppression therapy.
    ClinicalTrials.gov Identifier: NCT01492972
  • 11-497 Proton Therapy vs. IMRT for Low or Intermediate Risk Prostate Cancer (PARTIQoL): In this research study, we are comparing IMRT to proton beam therapy to determine which therapy best minimizes the side effects of treatment for men being treated for prostate cancer.
    ClinicalTrials.gov Identifier: NCT01617161
  • COMPPARE: A Prospective Comparative Study of Outcomes with Proton and Photon Radiation in Prostate Cancer: This study is a large, prospective, pragmatic, controlled comparison of patient-centric outcomes [quality of life, toxicity and disease control] between parallel cohorts of men with prostate cancer treated simultaneously at proton therapy facilities and at geographically similar conventional (photon-based) radiation facilities using intensity-modulated radiation therapy (IMRT) techniques.
    ClinicalTrials.gov Identifier: NCT03561220

Registry

  • Registry - QOL
    REG001-09 Registry Study for Radiation Therapy Outcomes:
    The purpose of this research study is to collect and analyze information from patients being treated with various forms of radiation therapy.
    ClinicalTrials.gov Identifier: NCT01255748

Spine

  • Single-arm, phase II study assessing fertility preservation following proton therapy for young females with tumors of the lumbosacral spine, spinal cord or cauda equine.
    No NCT number

You can search for more clinical trials by visiting ClinicalTrials.gov

Participate in a Trial

If you are eligible for a clinical trial, someone from our team will likely reach out to you to communicate the details of the study. If you are interested in learning more about our trials, please contact your physician.