Clinical Trials /

Radiation Therapy in Preventing Liver Metastases in Patients With Uveal Melanoma Who HaveMonosomy 3 or DecisionDx Class 2 Disease and Are More Likely to Develop Liver Metastases

NCT02336763

Description:

This clinical trial studies giving radiation therapy to the liver in patients with uveal (eye) melanoma who have a specific chromosome loss (monosomy 3) or are DecisionDx Class 2 and therefore more likely to have their disease spread from the eye to the liver. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Early radiation to the liver may reduce the development of tumors in the liver and the overall risk of disease recurrence.

Related Conditions:
  • Uveal Melanoma
Recruiting Status:

Terminated

Phase:

N/A

Trial Eligibility

Document

<span class="go-doc-concept go-doc-intervention">Radiation</span> Therapy in Preventing Liver Metastases in Patients With <span class="go-doc-concept go-doc-disease">Uveal Melanoma</span> Who HaveMonosomy 3 or DecisionDx Class 2 Disease and Are More Likely to Develop Liver Metastases

Title

  • Brief Title: Radiation Therapy in Preventing Liver Metastases in Patients With Uveal Melanoma Who HaveMonosomy 3 or DecisionDx Class 2 Disease and Are More Likely to Develop Liver Metastases
  • Official Title: Prophylactic Hepatic Irradiation for Uveal Melanoma
  • Clinical Trial IDs

    NCT ID: NCT02336763

    ORG ID: 14-000903

    NCI ID: NCI-2014-02254

    Trial Conditions

    Iris Melanoma

    Medium/Large Size Posterior Uveal Melanoma

    Stage IIA Uveal Melanoma

    Stage IIB Uveal Melanoma

    Stage IIIA Uveal Melanoma

    Stage IIIB Uveal Melanoma

    Stage IIIC Uveal Melanoma

    Trial Interventions

    Drug Synonyms Arms

    Trial Purpose

    This clinical trial studies giving radiation therapy to the liver in patients with uveal
    (eye) melanoma who have a specific chromosome loss (monosomy 3) or are DecisionDx Class 2
    and therefore more likely to have their disease spread from the eye to the liver. Radiation
    therapy uses high energy x-rays to kill tumor cells and shrink tumors. Early radiation to
    the liver may reduce the development of tumors in the liver and the overall risk of disease
    recurrence.

    Detailed Description

    PRIMARY OBJECTIVES:

    I. Progression free survival in patients treated with prophylactic hepatic irradiation.

    SECONDARY OBJECTIVES:

    I. Acute and late term toxicity and overall survival.

    OUTLINE:

    Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for
    10 fractions over approximately 2 weeks.

    After completion of study treatment, patients are followed up every 6 months for 5 years.

    Trial Arms

    Name Type Description Interventions
    Treatment (external beam radiation therapy) Experimental Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.

    Eligibility Criteria

    Inclusion Criteria:

    - Histologically confirmed uveal melanoma

    - Monosomy 3 status (by fluorescent in situ hybridization [FISH] or multiplex
    ligation-dependent probe amplification [MLPA]) or DecisionDx class 2

    - Tumor thickness > 3.0 mm

    - Has received definitive treatment of uveal melanoma with brachytherapy, proton
    therapy, stereotactic radiosurgery, or enucleation

    - Karnofsky performance status (KPS) >= 70 or Eastern Cooperative Oncology Group (ECOG)

    - Total bilirubin < 1.5 mg/dl

    - Aspartate transaminase (AST) up to two times normal limit

    - Alanine transaminase (ALT) up to two times normal limit

    - Creatinine < 2.0 mg/dl

    - Functional left kidney based on computed tomography (CT) imaging

    - Positron emission tomography (PET)/CT demonstrating no evidence of metastatic disease

    - If a woman is of childbearing potential, a negative serum pregnancy test must be
    documented; women of childbearing potential must agree to use contraception for the
    duration of radiation therapy (approximately 3 weeks)

    - Understands the trial and procedures and is willing and able to sign the Informed
    Consent Form

    Exclusion Criteria:

    - Previous malignancy, other than localized cutaneous squamous cell carcinoma or basal
    cell carcinoma

    - History of prior irradiation to the thorax or abdomen

    - Inadequate hepatic or kidney function (as specified above)

    - Active peptic ulcer disease

    - Upper gastrointestinal bleeding

    - Pregnant women or women that refuse to use contraception throughout the entire study
    period

    - Currently receiving chemotherapy

    - Refuses to sign the informed consent form

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Progression-free survival

    Reduction in liver metastasis

    Secondary Outcome Measures

    Frequency and severity of acute toxicity per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4

    Frequency and severity of late toxicity per NCI CTCAE version 4

    Overall survival

    Distant failure rates

    Disease-specific survival

    Trial Keywords