Proton Radiation Therapy for Gliomas

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Massachusetts General Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Helen A. Shih, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01358058
First received: May 17, 2011
Last updated: October 22, 2014
Last verified: October 2014

May 17, 2011
October 22, 2014
May 2011
May 2015   (final data collection date for primary outcome measure)
Efficacy [ Time Frame: 7 years ] [ Designated as safety issue: No ]
To assess progression free survival of this treatment program.
Progression free survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01358058 on ClinicalTrials.gov Archive Site
  • Safety and Tolerability [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]
    To assess the number of participants with late effects from radiation therapy
  • Overall survival [ Time Frame: 7 years ] [ Designated as safety issue: No ]
    To assess overall survival of this treatment program.
  • Number of participants with late effects from radiation therapy [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Proton Radiation Therapy for Gliomas
Phase II Study of Proton Radiation Therapy for Low Grade and Favorable Grade 3 Gliomas

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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Low Grade Glioma
  • WHO Grade 3 Glioma With IDH1 Mutation
  • WHO Grade 3 Glioma With 1p/19q Codeletion
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.
Experimental: Proton radiation therapy
Single arm study delivering fractionated proton therapy over 6 week (54-59.4 Gy(RBE))
Intervention: Radiation: Proton radiation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
May 2018
May 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Tarin Grillo 617-724-3661 tgrillo@partners.org
United States
 
NCT01358058
10-439
Yes
Helen A. Shih, MD, Massachusetts General Hospital
Massachusetts General Hospital
National Cancer Institute (NCI)
Principal Investigator: Helen A Shih, MD Massachusetts General Hospital
Massachusetts General Hospital
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP