Text Size

Proton Radiation Therapy for Low Grade Gliomas

This study is currently recruiting participants.
Verified May 2013 by Massachusetts General Hospital
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Helen A. Shih, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01358058
First received: May 17, 2011
Last updated: May 2, 2013
Last verified: May 2013
History of Changes
  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 Gliomas
Protoplasmic Astrocytomas
Fibrillary Astrocytomas
Gemistocytic Astrocytomas
Oligoastrocytomas
Oligodendrogliomas
Other WHO Grade II/IV Gliomas
 Radiation: Proton radiation
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Proton Radiation Therapy for Low Grade Gliomas

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer
U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    To assess progression free survival of this treatment program.


Secondary Outcome Measures:
  • Safety and Tolerability [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    To assess the number of participants with late effects from radiation therapy

  • Overall survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    To assess overall survival of this treatment program.


Estimated Enrollment: 40
Study Start Date: May 2011
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2015 (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 Gy(RBE))
 Radiation: Proton radiation
Total dose of 54 Gy(RBE) at 1.8 Gy(RBE) per daily fraction delivered 5 days per week on weekdays for 6 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, 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 (a limited exam at 6 months, and full exam annually).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed low-grade gliomas
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01358058

Contacts
Contact: Helen A Shih, M.D. 617-643-7250 hshih@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

No publications provided

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
Study First Received: May 17, 2011
Last Updated: May 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Brain tumors
Radiation
Proton
Gliomas

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

ClinicalTrials.gov processed this record on June 17, 2013