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Closed (no longer recruiting)Last updated: 12 February 2024

FSRT (EYE STUDY): This phase 0 trial is trying to determine the effect of adding radiotherapy to stereotactic treatment for patients with choroidal melanomaCan reduced dose radiotherapy delivered in standard fractionation improve the therapeutic index for stereotactic treatment of juxtapapillary choroidal melanoma?

Clinical summary

Summary

Trial 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.

Conditions

This trial is treating patients with Choroidal Melanoma.

Cancer

Head and Neck Cancers Head and Neck

Age

People0 - 70

Phase

0

Trial Acronym

FSRT (EYE STUDY)

More information

Trial Identifiers

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Trial sponsor

Peter MacCallum Cancer Centre

Scientific Title

Can reduced dose radiotherapy delivered in standard fractionation improve the therapeutic index for stereotactic treatment of juxtapapillary choroidal melanoma?

Eligibility

Inclusion

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

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

Inclusion

  • Your cancer has not spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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