Active Clinical Trials

Clinical trials are scientific studies in which new treatments are tested in patients to determine if they are effective and safe.

The Department of Radiation Oncology's clinical trials offer access to promising new therapies. Browse our clinical trials below, and click on the trial name for more information.

Brain/CNS tumors

• Pilot Study of In-Room PET in Proton Radiation Therapy
• This trial evaluates the use of a type of radiological imaging called PET to take pictures of a patient’s tumor immediately after they receive a treatment with proton radiation therapy.
• Principal Investigator: Helen Shih, MD
• DFCI #10-241

Brain tumors

• Local Control, Quality of Life and Toxicities in Adults with Brain Tumors undergoing Proton Radiation Therapy
• The goal of this study is to enroll adult patients with brain tumors who receive proton radiation to understand how proton radiation affects quality of life and side effects the patient may experience during or after treatment. The study will also evaluate tumor control outcomes.
• Principal Investigator: Helen Shih, MD
• DFCI #17-250

Breast

• Pilot Study of Preoperative Accelerated Partial Breast Irradiation for Triple Negative Breast Cancer Using Proton Beam Scanning
  
  • This study evaluates the use of a technique called accelerated partial breast irradiation using proton radiotherapy in patients with triple negative breast cancer.
  • Principal Investigator: Rachel Jimenez, MD
  • DFCI # 17-416
    
    
• The differential impact of proton beam irradiation versus conventional radiation on organs-at-risk in stage II-III breast cancer patients
  
  • The goal of this study is to evaluate two different radiation techniques (proton radiotherapy or photon radiotherapy) for the treatment of breast cancer.
  • Principal Investigator: Rachel Jimenez, MD
  • DFCI # 17-031
    
    
• 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 goal of this study is to evaluate two different radiation techniques (proton radiotherapy or photon radiotherapy) for the treatment of breast cancer.
  • Principal Investigator: Shannon MacDonald, MD
  • DFCI #16-188

Colorectal

• Nivolumab and Ipilimumab and Radiation Therapy in Microsatellite Stable Colorectal Cancer
  
  • The goal of this study is to evaluate the utility of combining two immunotherapy medications called Nivolumab and Ipilimumab along with radiation therapy in patients with colorectal cancer with a specific type of mutational status called microsatellite stability.
  • Principal Investigator: Ted Hong, MD
  • DFCI #17-021

Colorectal cancer spread to the liver

• Phase Ib/II Study of TAS-102 plus radiation therapy for the treatment of the liver in patients with hepatic metastases from colorectal cancer
  
  • This trial evaluates a combination of radiation therapy along with a new medication called TAS-102 for the treatment of liver metastases that were from colorectal cancer.
  • Principal Investigator: Ted Hong, MD
  • DFCI # 17-231

Liver

• A Phase III Randomized Trial of Protons versus Photons for Hepatocellular Carcinoma
  
  • The goal of this study is to evaluate two different radiation techniques (proton radiotherapy or photon radiotherapy) for the treatment of liver cancer.
  • Principal Investigator: Ted Hong, MD
  • DFCI #17-733
    
    
• A Phase II Trial of Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer
  
  • The goal of this trial is to evaluate the utility of two medications called Durvalumab and Tremelimumab in combination with radiation for the treatment of cancers called hepatocellular carcinoma (a type of liver cancer) and biliary tract cancers.
  • Principal Investigator: Ted Hong, MD
  • DFCI #17-517

Low/intermediate grade glioma

• 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 study evaluates two different radiation techniques (proton beam therapy or intensity-modulated photon therapy- IMRT) for the treatment of patients with brain tumors called gliomas that are either grade II or grade III and have an IDH mutation. The goal is to determine whether one technique preserves brain function compared to the other.
• Principal Investigator: Helen Shih, MD
• DFCI #18-711

Meningioma

• A Phase I/II Trial of Increased Dose Intensity Modulated Proton Therapy (IMPT) for High-Grade Meningiomas
• This study evaluates the utility of a radiation technique, called intensity-modulated proton therapy, for the treatment of meningiomas. The study also seeks to evaluate whether a higher dose using this radiation technique will lead to improved outcomes.
• Principal Investigator: Helen Shih, MD
• DFCI #15-542

Nasopharyngeal

• Randomized Phase II and Phase III studies of individualized treatment for Nasopharyngeal carcinoma based on biomarker Epstein Barr Virus (EBV)
  
  • This study will use levels of a biomarker, Epstein Barr Virus, after treatment for nasopharyngeal cancer, to dictate further treatment and evaluate its utility as a blood-based biomarker for cancer activity.
  • Principal Investigator: Annie Chan, MD
  • DFCI #17-754

Neuroblastoma

• Phase II Study of Proton Radiation Therapy for Neuroblastoma
  • The goal of this study is to evaluate the effectiveness of using proton radiotherapy for the treatment of neuroblastoma.
  • Principal Investigator: Shannon MacDonald, MD
  • DFCI #13-443

Non-small cell lung cancer

• A Phase II Trial of Integrating Stereotactic Body Radiation Therapy with Selective Targeted Therapy in Stage IV Oncogene-driven Non-Small Cell Lung Cancer
  
  • This trial evaluates the use of a very targeted radiation technique, called Stereotactic Body Radiation Therapy, in patients with metastatic non-small cell lung cancer who have a particular mutation and are receiving a targeted biological agent.
  • Principal Investigator: Henning Willers, MD
  • DFCI #14-370
    
    
• Phase III Randomized Trial Comparing Overall Survival After Photon Versus Proton Chemoradiotherapy for Inoperable Stage II-IIIB NSCLC
  
  • This trial will evaluate 2 radiation techniques in combination with chemotherapy, protons versus photons, in the treatment of non-small cell lung cancer that cannot be removed by surgery.
  • Principal Investigator: Henning Willers, MD
  • DFCI #14-268

Oropharyngeal

• NCI: IMPT or IMRT in Oropharyngeal cancer of head and neck
  • The goal of this study is to evaluate two different radiation techniques (intensity-modulated proton therapy-IMPT or intensity-modulated photon therapy-IMRT) for the treatment of head and neck cancer. All patients will receive chemotherapy along with radiation therapy.
  • Principal Investigator: Paul Busse, MD, PhD
  • DFCI #16-155

Pancreatic

• A Randomized Phase 2 Study of Losartan and Nivolumab in Combination with FOLFIRINOX and SBRT in Localized Pancreatic Cancer
  
  • The goal of this trial is to evaluate combinations of medications called Losartan and Nivolumab along with FOLFIRINOX chemotherapy and Stereotactic Body Radiation Therapy (SBRT) in the treatment of pancreatic cancer.
  • Principal Investigator: Ted Hong, MD
  • DFCI #18-179

Pediatric brain/CNS tumors

• Craniospinal Irradiation using Proton Beam Scanning with Selective Vertebral Body/Bone Sparing to Improve Marrow Reserve and Decrease Growth Decrement for Children
  
  • This study evaluates whether using a radiation technique called proton radiation in patients who require craniospinal radiation (treatment to the entire brain and spine) decreases some of the negative effects radiation has on the surrounding tissues.
  • Principal Investigator: Shannon MacDonald, MD
  • DFCI #17-283

Pediatric cancers

• Proton and Photon Consortium Registry (PPCR): A Multi Center Registry of Pediatric Patients treated with Radiation Therapy
• The goal of this registry is to enroll children treated with proton radiation in the United States to better evaluate the benefits of this treatment compared to other therapies. The data collected from this study will help to facilitate research on proton beam radiation therapy for children.
• Principal Investigator: Torunn Yock, MD
• DFCI #12-103

Prostate

• Phase III randomized clinical trial of proton therapy vs IMRT for low or intermediate risk prostate cancer
  
  • The purpose of this study is to evaluate two different radiation techniques (proton beam therapy or intensity-modulated photon therapy- IMRT) for the treatment of low to intermediate risk prostate cancer, to determine which treatment minimizes side effects.
  • Principal Investigator: Jason Efstathiou, MD, DPhil
  • DFCI # 11-497

Retroperitoneal sarcoma

• Phase I/II Trial of Pre-Operative Image Guided Intensity Modulated Proton Radiation Therapy (IMPT) or Photon (IMRT) with Simultaneously Integrated Boost to the High Risk Margin for Retroperitoneal Sarcomas
  
  • The purpose of this study is to evaluate two different radiation techniques (intensity-modulated proton therapy-IMPT or intensity-modulated photon therapy- IMRT) for the treatment of a type of cancer called sarcoma that occurs in the location at the far back of the abdomen (retroperitoneal). This also will evaluate the highest radiation dose that be delivered with either technique for this type of cancer.
  • Principal Investigator: Tom Delaney, MD
  • DFCI # 12-100

Rhabdomyosarcoma

• A Phase II Trial of Proton Radiation for the Treatment of Pediatric Rhabdomyosarcoma
• The purpose of this study is to evaluate whether proton beam therapy can reduce side effects when treating a cancer called rhabdomyosarcoma, a cancer that typically afflicts children.
• Principal Investigator: Torunn Yock, MD
• DFCI #04-188

Sinonasal

• Proton vs. IMRT for Sinonasal Malignancies
  • The purpose of this study is to evaluate two different radiation techniques (intensity-modulated proton therapy-IMPT or intensity-modulated photon therapy- IMRT) for sinonasal cancers.
  • Principal Investigator: Annie Chan, MD
  • DFCI #10-308

Vestibular schwannoma

• Hearing Outcomes Using Fractionated Proton Radiation Therapy for Vestibular Schwannoma
  
  • The purpose of this trial is to evaluate the effect of using a radiation technique called fractionated stereotactic radiotherapy with protons in the treatment of vestibular schwannoma on long-term hearing preservation and controlling the tumor.
  • Principal Investigator: Helen Shih, MD
  • DFCI #10-218