Trial Outcomes & Findings for 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 (NCT NCT02336763)
NCT ID: NCT02336763
Last Updated: 2020-07-24
Results Overview
TERMINATED
NA
2 participants
Up to 5 years
2020-07-24
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Treatment (External Beam Radiation Therapy)
n=2 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: 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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 3 months of study treatmentPopulation: study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: More than 3 months after study treatmentPopulation: study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure.
Cumulative incidence approach (Kaplan-Meier \[K-M\] plots and Cox proportional hazard modeling) will be used to estimate distant failure rates.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure.
Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used to estimate disease-specific survival.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (External Beam Radiation Therapy)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place