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

Phase 1

Active, not recruiting

Conditions: Juxtapapillary choroidal melanoma
Cancer - Malignant melanoma
Eye - Diseases / disorders of the eye

Registration Number: ACTRN12614000531617

Lead Sponsor: Peter MacCallum Cancer Centre

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Active, not recruiting

Sex: All

Target Recruitment: 20

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Distant metastasis free survival (DMFS): DMFS is defined as the time from the date of start of radiotherapy to the date of the first distant metastasis or date of death without distant metastasis. DMFS will be censored by the closeout date and the date of the last follow-up for patients lost to follow-up.[ 5 years after completion of accrual.]

Secondary Outcome Measures