Proton Therapy Clinical Trials

NCT02698254 - Pilot Trial of Dose-Volume Constraints for Reirradiation of Recurrent Brain Tumors. The goal of this clinical research study is to test the safety of repeat radiation for brain tumors that came back after the first course of radiation. Researchers also want to learn how repeat radiation affects your quality of life.  

NCT02693990 - A Phase I/II Trial of Increased Dose Intensity Modulated Proton Therapy (IMPT) for High-Grade Meningiomas

The goal of this clinical research study is to learn if increased-dose intensity modulated proton therapy (IMPT) can help to control the disease in patients with meningioma.

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

The purpose of this study is to compare a different radiation therapy schedule and higher radiation dose [higher dose group] to the standard dose of radiation therapy [standard dose group]. Both groups will receive usual chemotherapy, temozolomide. The higher radiotherapy dose could shrink your cancer, but it could also cause side effects. This study will allow the researchers to know whether this higher dose is better, the same, or worse than the usual approach. To be better, the study should increase life by six months or more compared to the usual approach. Two methods of giving radiation therapy will also be compared. They are proton beam radiation and intensity-modulated radiation. 

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. Proton beam radiation therapy uses tiny charged particles to deliver radiation directly to the tumor and may cause less damage to normal tissue. Intensity-modulated or photon beam radiation therapy uses high-energy x-ray beams shaped to treat the tumor and may also cause less damage to normal tissue. Patients will be more likely to be randomized to proton beam radiation therapy. It is not yet known if proton beam radiation therapy is more effective than photon-based beam intensity-modulated radiation therapy in treating patients with glioma.

Pediatric and Adult

NCT02698254 - Pilot Trial of Dose-Volume Constraints for Reirradiation of Recurrent Brain Tumors

The goal of this clinical research study is to test the safety of repeat radiation for brain tumors that came back after the first course of radiation. Researchers also want to learn how repeat radiation affects your quality of life.

NCT01245712 - Assessing the Cosmesis and Toxicity of Partial Breast Irradiation Using Proton Beam Irradiation

The goal of this 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.

NCT02603341 - Pragmatic Phase III Randomized Trial of Proton vs. Photon Therapy for Patients with Non-metastatic Breast Cancer Receiving Comprehensive Nodal Radiation: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial

The primary objective is to assess the effectiveness of proton vs. photon therapy in reducing major cardiovascular events (MCE), defined as atherosclerotic coronary heart disease or other heart disease death, myocardial infarction, coronary revascularization, or hospitalization for major cardiovascular event (heart failure, valvular disease, arrhythmia, or unstable angina or other major cardiovascular event).

PA19-0154 - Exploring the effect of proton versus photon radiation on tase function in patients iwth head and neck cancer.

NCT01893307 - 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 2 radiation treatments for head and neck cancer. The 2 treatments are intensity modulated photon therapy (IMRT) and intensity modulated proton therapy (IMPT). Participants will receive chemotherapy along with radiation therapy.IMPT is designed to use beams of proton particles to send radiation to the tumor. IMRT is designed to use beams of photon therapy to send radiation to the tumor. Both of these types of radiation treatment may give a full dose of radiation treatment to the tumor while not damaging as much of the healthy tissue around it. 

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.

NCT01629498 - Intensity-Modulated Scanning Beam Proton Therapy (IMPT) With Simultaneous Integrated Boost (SIB)

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  IMRT therapy when both are combined with standard chemotherapy. Participants will also receive standard chemotherapy. IMPT therapy and IMRT therapy are types of radiation therapy that are designed to use a beam of proton or photon particles (similar to getting an x-ray) to send radiation inside the body to the tumor.

NCT01993810 - 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. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor, such as photon or proton beam radiation therapy, may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as paclitaxel, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether proton chemoradiotherapy is more effective than photon chemoradiotherapy in treating non-small cell lung cancer.

NCT03987386 - Conventional or Hypofractioned Radiation therapy in Treating Patients with Prostate Cancer

This phase III trial studies how well hypofractionated radiation therapy works compared to the conventional one in treating patients with prostate cancer. Radiation therapy uses high energy beam to kill tumor cells and shrink tumors. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.

NCT03561220 -  A Prospective Comparative Study Of Outcomes With Proton And Photon Radiation In Prostate Cancer (COMPPARE)

This study is a large, prospective, pragmatic, controlled comparison of patient-centric outcomes [quality of life (QQL), 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.