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NCT04577742 Clinical Trial

Uveal Melanoma and Brachytheraphy: Long-term Outcomes.

Uveal Melanoma Clinical Trial

Official title:
Long-term Outcomes in Uveal Melanoma After Ruthenium-106 Brachytherapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04577742
Other study ID # 2020/106
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2011
Est. completion date March 30, 2020

Study information
Verified date October 2020
Source Federico II University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study investigated the visual and anatomical outcomes, tumor control, tumor recurrence, distant metastasis and cancer free survival in patients affected by uveal melanoma and undergoing Ru-106 plaque brachytherapy between February 2011 and March 2020

Recruitment information / eligibility
Status Completed
Enrollment 350
Est. completion date March 30, 2020
Est. primary completion date March 20, 2020
Accepts healthy volunteers
Gender All
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria:

- age older than 40 years

- diagnosis of uveal melanoma

Exclusion Criteria:

- age older than 80 years

- No diagnosis of uveal melanoma

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• 106 Ruthenium plaque brachytherapy
All patients, affected by uveal melanoma, were treated with 106 Ruthenium plaque brachytherapy to a total dose of 100 Gy to the tumor apex. The time of implant duration was calculated according to the conventional central-axis-point dose calculation

Locations
Country Name City State
Italy University of Naples "Federico II" Naples

Sponsors (1)
Lead Sponsor Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate long-term outcomes in patients underwent brachytherapy for uveal melanoma To investigate the visual and anatomical outcomes, tumor control, tumor recurrence, distant metastasis and cancer free survival Mean follow-up was 4 years (3 months-9 years)
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