ACTRN12614000531617
Active, not recruiting
Phase 1
Can reduced dose radiotherapy delivered in standard fractionation improve the therapeutic index for stereotactic treatment of juxtapapillary choroidal melanoma?
Peter MacCallum Cancer Centre0 sites20 target enrollmentMay 20, 2014
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Juxtapapillary choroidal melanoma
- Sponsor
- Peter MacCallum Cancer Centre
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Primary choroidal melanoma (small and medium sized)
- •\- A clinical diagnosis of CM made by a suitably trained ophthalmologist is mandatory
- •\- Features that define CM and must be present are a choroidal mass that is pigmented or hypopigmented AND EITHER:
- •a) Tumour height measured on beta ultrasound to be 2\.5mm or greater OR
- •b) Documented growth of a lesion \<2\.5mm in height
- •2\. Tumour height to 8mm or less
- •3\. Tumour basal diameter 16mm or less
- •4\. Visual acuity better than 6/60 ( or 0\.1\)
- •5\. No evidence of metastatic disease on liver ultrasound
- •6\. Age 70 or less
Exclusion Criteria
- •1\. Tumour involving the iris or ciliary body
- •2\. Cytopathologic diagnosis is not uveal melanoma
- •3\. Previous treatment to the affected eye with radiation, laser or thermotherapy
- •4\. Non\-malignant disease of the affected eye (that already has or could affect vision)
- •5\. Known to have diabetes mellitus
- •6\. Prior diagnosis of cancer that was:
- •\- more than 5 years prior to current diagnosis with subsequent evidence of disease recurrence or clinical expectation of recurrence is greater than 10%
- •\- within 5 years of current diagnosis with the exception of successfully treated basal cell or squamous cell skin carcinoma or carcinoma in situ of the cervix
- •7\. Patients with clinical evidence of metastatic disease.
- •8\. Women who are pregnant
Outcomes
Primary Outcomes
Not specified
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