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.

In fact, 85 percent of our Proton Center patients participate in a clinical trial or enroll in a clinical data registry.

Brain/CNS

  • 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

Breast

  • PCG 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

Esophageal

  • NRG 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

  • EA3191 A Phase II Randomized Trial of Adjuvant Therapy With Pembrolizumab After Resection of Recurrent/Second Primary Head and Neck Squamous Cell Carcinoma With High Risk Features: This phase II trial studies the effect of pembrolizumab in combination with radiation therapy or pembrolizumab alone compared to the usual approach (chemotherapy plus radiation therapy) after surgery in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or patients with a second head and neck cancer that is not from metastasis (primary).
    ClinicalTrials.gov: NCT04671667

Lung

  • NRG LU008 Testing the Addition of High Dose, Targeted Radiation to the Usual Treatment for Locally-Advanced Inoperable Non-small Cell Lung Cancer: This phase III trial compares the effect of adding stereotactic body radiation therapy (SBRT) to standard treatment (image guided radiation therapy [IGRT] and chemotherapy followed by immunotherapy with durvalumab) versus standard treatment alone in treating patients with non-small cell lung cancer that cannot be treated by surgery (inoperable). SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. IGRT is a type of radiation that uses a computer to create picture of the tumor, to help guide the radiation beam during therapy, making it more accurate and causing less damage to healthy tissue. Standard chemotherapy used in this trial consists of combinations of the following drugs: cisplatin, carboplatin, paclitaxel, pemetrexed, and etoposide. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It works by stopping the growth and spread of tumor cells. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by blocking the action of a certain substance in the body that may help tumor cells multiply. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Immunotherapy with durvalumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Adding SBRT to the standard treatment of IGRT with chemotherapy and immunotherapy may be more effective at treating patients with inoperable non-small cell lung cancer than giving the standard treatment alone.
    ClinicalTrials.gov Identifier: NCT05624996

Lymphoma

  • COG ANHL 1931 Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma: This phase III trial compares the effects of nivolumab with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Treatment for PMBCL involves chemotherapy combined with an immunotherapy called rituximab. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nivolumab with chemo-immunotherapy may help treat patients with PMBCL.
    ClinicalTrials.gov Identifier: NCT04759586

Pancreas

  • PCG PAN009-18 Proton Radiation for Unresectable, Borderline Resectable, or Medically Inoperable Carcinoma of the Pancreas: This research study is 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. The purpose is to determine if an increase in the number of surgical resection pancreatic adenocarcinoma is higher than historical data by using a combined treatment of proton radiation with capecitabine (oral chemotherapy).
    ClinicalTrials.gov Identifier: NCT02598349

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

  • PCG 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
  • PCG GU010-18: Postoperative or Salvage Radiotherapy for Node Negative Prostate Cancer Following Radical Prostatectomy: The purpose of this study is to see what effects, good and/or bad, proton radiation, and/or conventional radiation and hormonal therapy (if applicable), has on prostate cancer that has already returned or the risk of prostate cancer returning.
    ClinicalTrials.gov Identifier: NCT00969111
  • EA8191 Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Using PET/CT Imaging: This phase III trial compares the addition of apalutamide, with or without targeted radiation therapy, to standard of care treatment versus standard of care treatment alone in patients with prostate cancer biochemical recurrence (a rise in the blood level of prostate-specific antigen [PSA] after treatment with surgery or radiation).
    ClinicalTrials.gov Identifier: NCT04423211
  • NRG GU009 Parallel Phase III Randomized Trials for High Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk With Radiation: This phase III trial compares less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in patients with high risk prostate cancer and high gene risk score.
    ClinicalTrials.gov Identifier: NCT04513717
  • NRG GU010 Parallel Phase III Randomized Trials of Genomic Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation (GUIDANCE): This phase III trial uses the Decipher risk score to guide intensification (for higher Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to better match therapies to an individual patient's cancer aggressiveness. The Decipher risk score evaluates a prostate cancer tumor for its potential for spreading. In patients with low-risk scores, this trial compares radiation therapy alone to the usual treatment of radiation therapy and hormone therapy (androgen deprivation therapy).
    ClinicalTrials.gov Identifier: NCT05050084
  • NRG-GU013 Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With High Risk Prostate Cancer: This phase III trial compares stereotactic body radiation therapy (SBRT) (five treatments over two weeks using a higher dose per treatment) to usual radiation therapy (20 to 45 treatments over 4 to 9 weeks) for the treatment of high-risk prostate cancer. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period of time. This trial is evaluating if shorter duration radiation prevents cancer from coming back as well as the usual radiation treatment.
    ClinicalTrials.gov Identifier: NCT05946213

Registry

  • Registry - QOL
    PCG 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.