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Proton Radiation Therapy for Gliomas

This study is currently recruiting participants.
Verified July 2017 by Helen A. Shih, MD, Massachusetts General Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01358058
First Posted: May 23, 2011
Last Update Posted: July 19, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Helen A. Shih, MD, Massachusetts General Hospital
  Purpose

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 Intervention Phase
Low Grade Glioma WHO Grade 3 Glioma With IDH1 Mutation WHO Grade 3 Glioma With 1p/19q Codeletion Radiation: Proton radiation Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Helen A. Shih, MD, Massachusetts General Hospital:

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


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

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


Estimated Enrollment: 50
Study Start Date: May 2011
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

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.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01358058


Contacts
Contact: Tarin Grillo 617-724-3661 tgrillo@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Helen A Shih, M.D.         
Sponsors and Collaborators
Massachusetts General Hospital
National Cancer Institute (NCI)
Investigators
Principal Investigator: Helen A Shih, MD Massachusetts General Hospital
  More Information

Responsible Party: Helen A. Shih, MD, Attending Radiation Oncologist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01358058     History of Changes
Other Study ID Numbers: 10-439
First Submitted: May 17, 2011
First Posted: May 23, 2011
Last Update Posted: July 19, 2017
Last Verified: July 2017

Keywords provided by Helen A. Shih, MD, Massachusetts General Hospital:
Brain tumors
Radiation
Proton
Gliomas

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue