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

URL:

https://clinicaltrials.gov/show/NCT02336763

Trial Eligibility

Document

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

  • ORG STUDY ID: 14-000903
  • SECONDARY ID: NCI-2014-02254
  • SECONDARY ID: JCCCID466
  • NCT ID: NCT02336763

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

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

NameTypeDescriptionInterventions
Treatment (external beam radiation therapy)ExperimentalPatients 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
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Progression-free Survival
    Time Frame:Up to 5 years
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:Frequency and Severity of Acute Toxicity Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4
    Time Frame:Within 3 months of study treatment
    Safety Issue:
    Description:
    Measure:Frequency and Severity of Late Toxicity Per NCI CTCAE Version 4
    Time Frame:More than 3 months after study treatment
    Safety Issue:
    Description:
    Measure:Overall Survival
    Time Frame:Up to 5 years
    Safety Issue:
    Description:
    Measure:Distant Failure Rates
    Time Frame:Up to 5 years
    Safety Issue:
    Description:Cumulative incidence approach (Kaplan-Meier [K-M] plots and Cox proportional hazard modeling) will be used to estimate distant failure rates.
    Measure:Disease-specific Survival
    Time Frame:Up to 5 years
    Safety Issue:
    Description:Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used to estimate disease-specific survival.

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Terminated
    Lead Sponsor:Jonsson Comprehensive Cancer Center

    Last Updated

    July 24, 2020