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

• ClinicalTrials.gov Identifier: NCT02336763
• Recruitment Status: Terminated
• First Posted: January 13, 2015
• Results First Posted: March 11, 2016
• Last Update Posted: July 24, 2020
• Sponsor: Jonsson Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Jonsson Comprehensive Cancer Center

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• 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: Radiation: External Beam Radiation Therapy; Other: Laboratory Biomarker Analysis
• Enrollment: 2

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Treatment (External Beam Radiation Therapy)
Arm/Group Description	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
Period Title: Overall Study
Started	2
Completed	2
Not Completed	0

Baseline Characteristics

Arm/Group Title		Treatment (External Beam Radiation Therapy)
Arm/Group Description		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
Overall Number of Baseline Participants		2
Baseline Analysis Population Description		only two subjects were enrolled
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	2 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	2 100.0%
	>=65 years	0 0.0%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	2 participants
	Female	1 50.0%
	Male	1 50.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	2 participants
		2

Outcome Measures

1. Primary Outcome

Title	Progression-free Survival
Description	[Not Specified]
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Treatment (External Beam Radiation Therapy)
Arm/Group Description:	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
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

2. Primary Outcome

Title	Reduction in Liver Metastasis
Description	[Not Specified]
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure.

Arm/Group Title	Treatment (External Beam Radiation Therapy)
Arm/Group Description:	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
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

3. Secondary Outcome

Title	Frequency and Severity of Acute Toxicity Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4
Description	[Not Specified]
Time Frame	Within 3 months of study treatment

Outcome Measure Data

Analysis Population Description

study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure.

Arm/Group Title	Treatment (External Beam Radiation Therapy)
Arm/Group Description:	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
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

4. Secondary Outcome

Title	Frequency and Severity of Late Toxicity Per NCI CTCAE Version 4
Description	[Not Specified]
Time Frame	More than 3 months after study treatment

Outcome Measure Data

Analysis Population Description

study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure.

Arm/Group Title	Treatment (External Beam Radiation Therapy)
Arm/Group Description:	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
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

5. Secondary Outcome

Title	Overall Survival
Description	[Not Specified]
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure.

Arm/Group Title	Treatment (External Beam Radiation Therapy)
Arm/Group Description:	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
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

6. Secondary Outcome

Title	Distant Failure Rates
Description	Cumulative incidence approach (Kaplan-Meier [K-M] plots and Cox proportional hazard modeling) will be used to estimate distant failure rates.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure.

Arm/Group Title	Treatment (External Beam Radiation Therapy)
Arm/Group Description:	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
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

7. Secondary Outcome

Title	Disease-specific Survival
Description	Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used to estimate disease-specific survival.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure.

Arm/Group Title	Treatment (External Beam Radiation Therapy)
Arm/Group Description:	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
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Treatment (External Beam Radiation Therapy)
Arm/Group Description	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
All-Cause Mortality
	Treatment (External Beam Radiation Therapy)
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Treatment (External Beam Radiation Therapy)
	Affected / at Risk (%)
Total	0/2 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Treatment (External Beam Radiation Therapy)
	Affected / at Risk (%)
Total	0/2 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Mitchell Kamrava, MD
• Organization: UCLA
• Phone: 310-825-9775
• EMail: mkamrava@mednet.ucla.edu

• Responsible Party: Jonsson Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT02336763
• Other Study ID Numbers: 14-000903; NCI-2014-02254 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); JCCCID466 ( Other Identifier: Jonsson Comprehensive Cancer Center )
• First Submitted: January 8, 2015
• First Posted: January 13, 2015
• Results First Submitted: February 12, 2016
• Results First Posted: March 11, 2016
• Last Update Posted: July 24, 2020