Clinical Trials /

Proton Radiation Therapy for Gliomas

NCT01358058

Description:

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.

Related Conditions:
  • Glioma
Recruiting Status:

Active, not recruiting

Phase:

N/A

Trial Eligibility

Document

Proton <span class="go-doc-concept go-doc-intervention">Radiation</span> Therapy for Gliomas

Title

  • Brief Title: Proton Radiation Therapy for Gliomas
  • Official Title: Phase II Study of Proton Radiation Therapy for Low Grade and Favorable Grade 3 Gliomas
  • Clinical Trial IDs

    NCT ID: NCT01358058

    ORG ID: 10-439

    Trial Conditions

    Low Grade Glioma

    WHO Grade 3 Glioma With IDH1 Mutation

    WHO Grade 3 Glioma With 1p/19q Codeletion

    Trial Interventions

    Drug Synonyms Arms

    Trial 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.

    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.

    Trial Arms

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

    Eligibility 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

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Efficacy

    Secondary Outcome Measures

    Safety and Tolerability

    Overall survival

    Trial Keywords

    Brain tumors

    Radiation

    Proton

    Gliomas