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Proton Radiation Therapy for Gliomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01358058
Recruitment Status : Active, not recruiting
First Posted : May 23, 2011
Last Update Posted : July 10, 2019
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Helen A. Shih, MD, Massachusetts General Hospital

Brief Summary:

In this research study the investigators are looking at a type of radiation called proton radiation. Proton radiation has been shown to deliver virtually no radiation beyond the area of the tumor, sparing surrounding normal tissue from exposure. This may reduce side effects that patients would normally experience with conventional radiation therapy.

In this research study the investigators are looking to determine if proton radiation with a reduced field size will be as effective in controlling tumor growth as photon therapy, while reducing the treatment-related side effects observed in patients with brain tumors.

Condition or disease Intervention/treatment Phase
Low Grade Glioma WHO Grade 3 Glioma With IDH1 Mutation WHO Grade 3 Glioma With 1p/19q Codeletion Radiation: Proton radiation Not Applicable

Detailed Description:

Proton radiation will be delivered daily for approximately 6 weeks. Subjects will be assessed weekly for side effects. Each visit will take about 15 minutes.

Subjects will have follow-up visits at 3, 6, 12, 24, 36, 48, 60, 72, and 84 months after their last proton radiation treatment. They will receive a physical exam, MRI, have blood tests (about 4 teaspoons) and answer questionnaires regarding medical history, quality of life, and emotional well-being. Subjects will also receive a neurocognitive exam annually.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Proton Radiation Therapy for Low Grade and Favorable Grade 3 Gliomas
Study Start Date : May 2011
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Proton radiation therapy
Single arm study delivering fractionated proton therapy over 6 week (54-59.4 Gy(RBE))
Radiation: Proton radiation
Total dose of 54-59.4 Gy(RBE) at 1.8 Gy(RBE) per daily fraction delivered 5 days per week on weekdays for 6-6.5 weeks.

Primary Outcome Measures :
  1. Efficacy [ Time Frame: 7 years ]
    To assess progression free survival of this treatment program.

Secondary Outcome Measures :
  1. Safety and Tolerability [ Time Frame: 7 years ]
    To assess the number of participants with late effects from radiation therapy

  2. Overall survival [ Time Frame: 7 years ]
    To assess overall survival of this treatment program.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed low-grade gliomas OR Grade III anaplastic glioma with either or both IDH1 mutation or 1p/19q codeletion
  • Subject must be indicated for radiation therapy
  • Life expectancy greater than 5 years
  • Willing to participate in rigorous neurocognitive evaluations at baseline and serially following treatment
  • Able to speak and comprehend English
  • Recovered from adverse events due to agents administered more than 4 weeks before entering study
  • Able to undergo MRI scans

Exclusion Criteria:

  • Prior cranial radiation therapy
  • Chemotherapy within 4 weeks prior to entering study
  • Pregnant or breastfeeding
  • Known brain metastases
  • Baseline neurocognitive or emotional disorders
  • Uncontrolled intercurrent illness
  • History of a different malignancy unless disease-free for at least 5 years
  • HIV positive on antiretroviral therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01358058

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Cancer Institute (NCI)
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Principal Investigator: Helen A Shih, MD Massachusetts General Hospital
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Responsible Party: Helen A. Shih, MD, Attending Radiation Oncologist, Massachusetts General Hospital Identifier: NCT01358058    
Other Study ID Numbers: 10-439
First Posted: May 23, 2011    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Keywords provided by Helen A. Shih, MD, Massachusetts General Hospital:
Brain tumors
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue