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

Not Applicable

Terminated

Conditions: Iris Melanoma
Stage IIA Uveal Melanoma
Stage IIIC Uveal Melanoma
Medium/Large Size Posterior Uveal Melanoma
Stage IIB Uveal Melanoma
Stage IIIB Uveal Melanoma
Stage IIIA Uveal Melanoma

Interventions: Radiation: External Beam Radiation Therapy
Other: Laboratory Biomarker Analysis

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Treatment (external beam radiation therapy)	Laboratory Biomarker Analysis	Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.
Treatment (external beam radiation therapy)	External Beam Radiation Therapy	Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.

Primary Outcome Measures

Name	Time	Method
Progression-free Survival	Up to 5 years
Reduction in Liver Metastasis	Up to 5 years

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Up to 5 years
Disease-specific Survival	Up to 5 years	Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used to estimate disease-specific survival.
Frequency and Severity of Late Toxicity Per NCI CTCAE Version 4	More than 3 months after study treatment
Distant Failure Rates	Up to 5 years	Cumulative incidence approach (Kaplan-Meier \[K-M\] plots and Cox proportional hazard modeling) will be used to estimate distant failure rates.
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