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Trial registered on ANZCTR


Registration number
ACTRN12614000531617
Ethics application status
Approved
Date submitted
15/05/2014
Date registered
20/05/2014
Date last updated
17/04/2024
Date data sharing statement initially provided
2/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Can reduced dose radiotherapy delivered in standard fractionation improve the therapeutic index for stereotactic treatment of juxtapapillary choroidal melanoma?
Scientific title
Can reduced dose radiotherapy delivered in standard fractionation improve the therapeutic index for stereotactic treatment of juxtapapillary choroidal melanoma?
Secondary ID [1] 284608 0
Nil
Universal Trial Number (UTN)
U1111-1156-8748
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Juxtapapillary choroidal melanoma 291910 0
Condition category
Condition code
Cancer 292257 292257 0 0
Malignant melanoma
Eye 292292 292292 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 289381 0
Treatment: Devices
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292120 0
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.
Timepoint [1] 292120 0
5 years after completion of accrual.
Secondary outcome [1] 308233 0
Freedom from local progression (FFLP): FFLP is defined as the time from the date of start of radiotherapy to the date of the first local progression. Death and distant metastasis will be considered censoring events. FFLP will be censored by the closeout date for patients alive and without progression and by the date of the last follow-up for patients lost to follow-up.
Timepoint [1] 308233 0
5 years after completion of accrual.
Secondary outcome [2] 308234 0
Enucleation: Enucleation will be recorded as having occurred or not. The reason for enucleation will be i) tumour progression within the eye, ii) radiation toxicity or iii) other.
Timepoint [2] 308234 0
5 years after completion of accrual.
Secondary outcome [3] 308235 0
Visual Acuity (VA) will be measured by the treating ophthalmologist using a Snellen Chart.
Timepoint [3] 308235 0
5 years after completion of accrual. VA is assessed at Baseline, and then annually up to 10 years.
Secondary outcome [4] 308236 0
Radiation late effects will be assessed by the ophthalmologist at clinical follow-up. The Common Terminology Criteria version 4.0 (CTC v4.0).
Timepoint [4] 308236 0
5 years after completion of accrual. Radiation late effects will be assessed at 3, 6, 12, 18 and 24 months after completion of radiotherapy. There will then be annual assessment up to 10 years after completion of radiotherapy.

Eligibility
Key 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
Minimum age
No limit
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The Investigator should ensure that all of the following requirements are met prior to patient enrolment:
1. The patient meets all inclusion criteria and none of the exclusion criteria apply.
2. The patient has signed and dated all applicable consent forms.
3. All baseline assessments and investigations have been performed and recorded in the patients’ medical records (i.e. source documents).
4. The registration and eligibility Case Report Form(s) (CRF) has been completed, signed and dated by the Investigator
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a single arm pilot study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 0
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/07/2014
Actual
15/12/2014
Date of last participant enrolment
Anticipated
Actual
14/05/2020
Date of last data collection
Anticipated
30/05/2030
Actual
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6691 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 14324 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 289237 0
Other
Name [1] 289237 0
The Royal Australian and New Zealand College of Radiologists
Country [1] 289237 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
305 Grattan Street
Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 287911 0
None
Name [1] 287911 0
Address [1] 287911 0
Country [1] 287911 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291007 0
Peter MacCallum Cancer Centre Ethics Committee
Ethics committee address [1] 291007 0
Ethics Committee Secretariat
Locked Bag 1, A'Beckett Street
Melbourne VIC 8006
Ethics committee country [1] 291007 0
Australia
Date submitted for ethics approval [1] 291007 0
15/05/2014
Approval date [1] 291007 0
01/09/2014
Ethics approval number [1] 291007 0
14/71

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48438 0
Dr Claire Phillips
Address 48438 0
Peter MacCallum Cancer Centre
Locked Bag 1, A'Beckett Street
Melbourne VIC 8006
Country 48438 0
Australia
Phone 48438 0
+61 3 8559 5000
Fax 48438 0
+61 3 8559 7729
Email 48438 0
[email protected]
Contact person for public queries
Name 48439 0
Mr Haris Ahmad
Address 48439 0
Peter MacCallum Cancer Centre
Locked Bag 1, A'Beckett Street
Melbourne VIC 8006
Country 48439 0
Australia
Phone 48439 0
+61 3 8559 8566
Fax 48439 0
+61 3 8559 7729
Email 48439 0
[email protected]
Contact person for scientific queries
Name 48440 0
Claire Phillips
Address 48440 0
Peter MacCallum Cancer Centre
Locked Bag 1, A'Beckett Street
Melbourne VIC 8006
Country 48440 0
Australia
Phone 48440 0
+61 3 8559 5000
Fax 48440 0
+61 3 8559 7729
Email 48440 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Deidentified data will be used for the analysis and write up of the results. These will consider the outcomes of the group rather than individuals. The results will not reveal anything about individual participants. Group data will presented for scientific publications such as median age, sex distribution, visual acuity prior to radiotherapy, tumour features.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.