Ocular Melanoma
Conditions
Keywords
eye plaque brachytherapy
Brief summary
This prospective registry study will evaluate doses utilized in eye plaque brachytherapy for the treatment of ocular melanoma and their associated outcomes. The goal of this study is to evaluate if lower doses of radiation can maintain high local control rates while minimizing the toxicities related to radiation therapy.
Interventions
OTHERData collection
Information about radiation therapy via eye plaque brachytherapy and follow up
Sponsors
Duke University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients 18 years of age or older with unilateral primary choroidal melanoma * Patients with diagnosis of small or medium ocular melanomas amenable to plaque brachytherapy (as determined by treating ocular oncologist). Typically this would include tumors with apical height ≤10mm and basal diameter ≤16mm (small and medium tumors per COMS (Collaborative Ocular Melanoma Study) * Patients with no clinical evidence of metastatic disease as confirmed by negative staging imaging (CT, MRI, and/or ultrasound) * Patients with best-corrected visual acuity in the fellow eye of 20/200 or better * Patients must be treated with IsoAid Eye Physics eye plaques
Exclusion criteria
* Patients whose tumors are circumferential around the optic disc and cannot be adequately covered by the prescription dose are ineligible. * Similarly, patients with extrascleral tumor extension detected during echography or clinical exam, diffuse, ring or multifocal tumors that cannot be encompassed in a single episcleral plaque or tumors judged to be predominantly ciliary body or iris melanoma will be considered ineligible * Previous treatment for ocular melanoma in either eye or treatment of any condition secondary to the tumor are ineligible. * Patients with a history of other primary or metastatic cancers are not eligible, except for non-melanotic skin cancers * Patients with extraocular disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with no disease recurrence within the radiation therapy field. | 5 years | Number of disease free participants expressed as a percentage of the total number of participants enrolled |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDianda Ayala-Peacock, MD
Duke University Health System (DUHS)
Outcome results
None listed