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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 : July 24, 2020
Sponsor:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (External Beam Radiation Therapy)
Hide 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
Arm/Group Title Treatment (External Beam Radiation Therapy)
Hide 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
Hide 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
1.Primary Outcome
Title Progression-free Survival
Hide Description [Not Specified]
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide Description [Not Specified]
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide Description [Not Specified]
Time Frame Within 3 months of study treatment
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide Description [Not Specified]
Time Frame More than 3 months after study treatment
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide Description [Not Specified]
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (External Beam Radiation Therapy)
Hide 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   --/-- 
Hide Serious Adverse Events
Treatment (External Beam Radiation Therapy)
Affected / at Risk (%)
Total   0/2 (0.00%) 
Hide 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%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mitchell Kamrava, MD
Organization: UCLA
Phone: 310-825-9775
EMail: mkamrava@mednet.ucla.edu
Layout table for additonal information
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