Radiation Therapy in Preventing Liver Metastases in Patients With Uveal Melanoma Who HaveMonosomy… (NCT02336763) | Clinical Trial Compass
TerminatedNot Applicable
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
Stopped: Closed due to lack of accrual
United States2 participantsStarted 2014-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 stu…