NCT02336763

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

Prophylactic Hepatic Irradiation for Uveal Melanoma

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
RADIATION	External Beam Radiation Therapy	Undergo external beam radiation therapy
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2015-01-13
• Last updated: 2020-07-24
• Results posted: 2016-03-11

Locations

1 site across 1 country: United States