None listed
Conditions
Brief summary
The purpose of this research project is to study whether it is possible to use a lower total dose of fractionated stereotactic radiotherapy (FSRT) and small daily radiation treatments to treat choroidal melanoma, in order to increase the chance of keeping vision in the eye and to reduce the severity of radiation side-effects but without affecting the chance of cure. Who is it for? You may be eligible to join this study if you are aged less than or equal to 70 years and have been diagnosed with primary choroidal melanoma (small and medium sized) by an ophthalmologist. You should not have received previous treatment to the affected eye with radiation, laser or thermotherapy. Study details All participants in this study will receive reduced dose FSRT to a dose of 60Gy in 30 fractions, given 5 fractions per week over 6 weeks. It is known that small daily doses of radiation (2Gy) will protect normal tissues from radiation injury when compared with large daily doses. When small daily doses are used it is called full fractionation. Tissues such as the eye nerve and the blood vessels at the back of the eye are especially protected by full fractionation. FSRT is a technology that makes it possible to use full fractionation to treat choroidal melanoma, so this may make it possible to reduce side-effects and keep better vision in the eye. Participants will be followed for up to 10 years to evaluate disease response, vision and any radiation side-effects.
Interventions
Reduced dose fractionated stereotactic radiotherapy (FSRT) to a dose of 60Gy in 30 fractions given 5 fractions per week. The overall duratioin of FSRT treatment is 6 weeks.
Sponsors
Peter MacCallum Cancer Centre
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 70 Years
Healthy volunteers
No
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 7. An ECOG performance status score of 0 - 2 8. Participants capable of childbearing are using adequate contraception 9. Available for follow up 10. Has provided written Informed Consent for participation in this trial
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 9. Unable to give informed consent
Outcome results
None listed