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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-02254 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| JCCCID466 | Other Identifier | Jonsson Comprehensive Cancer Center |
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Closed due to lack of accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (external beam radiation therapy) | Experimental | Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External Beam Radiation Therapy | Radiation | Undergo external beam radiation therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Up to 5 years | |
| Reduction in Liver Metastasis | Up to 5 years |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitchell Kamrava | Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. External Beam Radiation Therapy: Undergo external beam radiation therapy Laboratory Biomarker Analysis: Correlative studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| 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 |
| COMPLETED |
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| NOT COMPLETED |
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only two subjects were enrolled
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. External Beam Radiation Therapy: Undergo external beam radiation therapy Laboratory Biomarker Analysis: Correlative studies |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-free Survival | Study terminated early no analysis conducted. Subjects would need to be followed for up to 5 years to answer this objective. Subject 1 was followed 5 months and subject 2 was followed 2 months. Therefore, data was not collected from any subject for this Outcome Measure. | Posted | Up to 5 years |
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| Primary | Reduction in Liver Metastasis | study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure. | Posted | Up to 5 years |
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| Secondary | Frequency and Severity of Acute Toxicity Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4 | study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure. | Posted | Within 3 months of study treatment |
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| Secondary | Frequency and Severity of Late Toxicity Per NCI CTCAE Version 4 | study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure. | Posted | More than 3 months after study treatment |
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| Secondary | Overall Survival | study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure. | Posted | Up to 5 years |
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| Secondary | Distant Failure Rates | Cumulative incidence approach (Kaplan-Meier [K-M] plots and Cox proportional hazard modeling) will be used to estimate distant failure rates. | study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure. | Posted | Up to 5 years |
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| Secondary | Disease-specific Survival | Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used to estimate disease-specific survival. | study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure. | Posted | Up to 5 years |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. External Beam Radiation Therapy: Undergo external beam radiation therapy Laboratory Biomarker Analysis: Correlative studies | 0 | 2 | 0 | 2 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mitchell Kamrava, MD | UCLA | 310-825-9775 | mkamrava@mednet.ucla.edu |
| ID | Term |
|---|---|
| D000098943 | Uveal Melanoma |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D014604 | Uveal Neoplasms |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D005128 | Eye Diseases |
| D014603 | Uveal Diseases |
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