Expired Study
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Boston, Massachusetts 02114


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.


Study summary:

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.


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


Study is Available At:


Original ID:

10-439


NCT ID:

NCT01358058


Secondary ID:


Study Acronym:


Brief Title:

Proton Radiation Therapy for Gliomas


Official Title:

Phase II Study of Proton Radiation Therapy for Low Grade and Favorable Grade 3 Gliomas


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Massachusetts General Hospital


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

63


Enrollment Type:

Actual


Overall Contact Information

Official Name:Helen A Shih, MD
Principal Investigator
Massachusetts General Hospital

Study Dates

Start Date:May 2011
Completion Date:May 2020
Completion Type:Anticipated
Primary Completion Date:December 2019
Primary Completion Type:Anticipated
Verification Date:July 2019
Last Changed Date:July 9, 2019
First Received Date:May 17, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:Efficacy
Time Frame:7 years
Safety Issues:False
Description:To assess progression free survival of this treatment program.
Outcome Type:Secondary Outcome
Measure:Safety and Tolerability
Time Frame:7 years
Safety Issues:False
Description:To assess the number of participants with late effects from radiation therapy
Outcome Type:Secondary Outcome
Measure:Overall survival
Time Frame:7 years
Safety Issues:False
Description:To assess overall survival of this treatment program.

Study Interventions

Intervention Type:Radiation
Name:Proton radiation
Description: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.
Arm Name:Proton radiation therapy

Study Arms

Study Arm Type:Experimental
Arm Name:Proton radiation therapy
Description:Single arm study delivering fractionated proton therapy over 6 week (54-59.4 Gy(RBE))

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Massachusetts General Hospital
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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