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Clinical Trials/ACTRN12614000531617
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.

Registry
who.int
Start Date
May 20, 2014
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Peter MacCallum Cancer Centre

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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