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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prophylactic Hepatic Irradiation for Uveal Melanoma

Conditions
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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

Intervention / Treatment
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* Radiation: External Beam Radiation Therapy
* Other: Laboratory Biomarker Analysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (external beam radiation therapy)<br>Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks. | Radiation: External Beam Radiation Therapy<br>* Undergo external beam radiation therapy<br>* Other names: External Beam RT;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival |  | Up to 5 years | 
| Reduction in Liver Metastasis |  | Up to 5 years | 

Secondary Outcome Measures

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