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
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|ClinicalTrials.gov Identifier: NCT02336763|
Recruitment Status : Terminated (Closed due to lack of accrual)
First Posted : January 13, 2015
Results First Posted : March 11, 2016
Last Update Posted : April 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|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||Radiation: External Beam Radiation Therapy Other: Laboratory Biomarker Analysis||Not Applicable|
I. Progression free survival in patients treated with prophylactic hepatic irradiation.
I. Acute and late term toxicity and overall survival.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prophylactic Hepatic Irradiation for Uveal Melanoma|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Experimental: Treatment (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.
Radiation: External Beam Radiation Therapy
Undergo external beam radiation therapy
Other: Laboratory Biomarker Analysis
- Progression-free Survival [ Time Frame: Up to 5 years ]
- Reduction in Liver Metastasis [ Time Frame: Up to 5 years ]
- 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 ]
- Frequency and Severity of Late Toxicity Per NCI CTCAE Version 4 [ Time Frame: More than 3 months after study treatment ]
- Overall Survival [ Time Frame: Up to 5 years ]
- Distant Failure Rates [ Time Frame: 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.
- Disease-specific Survival [ Time Frame: Up to 5 years ]Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used to estimate disease-specific survival.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02336763
|United States, California|
|Jonsson Comprehensive Cancer Center|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Mitchell Kamrava||Jonsson Comprehensive Cancer Center|