Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000549628
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
29/09/2005
Date last updated
29/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Lymphatic Mapping and Selective (Sentinel) Lymph Node Biopsy for Melanoma Treatment Phase II Study for Therapy of Patients with Early Stage Melanoma
Scientific title
Lymphatic Mapping and Selective (Sentinel) Lymph Node Biopsy for Melanoma Treatment Phase II Study for Therapy of Patients with Early Stage Melanoma: The effect on tumour recurrence and overall survival
Universal Trial Number (UTN)
Trial acronym
Sentinel Node Biopsy Melanoma
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early Stage I/II Melanoma 674 0
Condition category
Condition code
Cancer 748 748 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment of patients with Early Stage I/II Melanoma using Lymphatic Mapping and Selective (Sentinel) Lymph Node Biopsy. This treatment has shown a high degree of safety with very few adverse events. The scheduled initial follow-up period will be for 5 years post-surgery.
Intervention code [1] 532 0
None
Comparator / control treatment
Control group
Historical

Outcomes
Primary outcome [1] 935 0
The fundamental primary outcome is clinical efficacy, measured by performance status (ECOG score), recurrence (local or distant) and overall survival.
Timepoint [1] 935 0
The clinical efficacy will be evaluated at regular time-points according to the schedule of clinical visits initially 3-monthly for 2 years, then 6-monthly for 2 years, then yearly thereafter.
Secondary outcome [1] 1786 0
The secondary outcomes are a range of other measures that will be correlated with clinical outcome. The aim is to determine any associations between the procedure and clinical responses. In some patients with a sentinel node positive for metastatic spread, some of these patients will be offered entry into an international multicentre clinical trial for randomization into either (i) radical surgical lymphatic nodal clearance, or (ii) regular ultrasound follow-up to the basin where the +ve sentionel node was removed, and later surgical clearance if required.
Timepoint [1] 1786 0
These will be evaluated at regular time-points according to the schedule of clinical visits initially 3-monthly for 2 years, then 6-monthly for 2 years, then yearly thereafter.
Secondary outcome [2] 1787 0
A further aim is to design better therapy.
Timepoint [2] 1787 0

Eligibility
Key inclusion criteria
Stage I and II cutaneous melanoma > 1mm in Breslow thickness or > Clark Level III; Absence of Metastases; Willingness to attend all scheduled clinical visits, tests and blood sampling.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Poor performance status; Pregnancy; Other malignancy.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2000
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 829 0
Other
Name [1] 829 0
Various private sources and awaiting public funding
Country [1] 829 0
Primary sponsor type
Name
John Wayne Cancer Institute/Royal Adelaide Hospital/University of Adelaide
Address
Country
Secondary sponsor category [1] 697 0
Individual
Name [1] 697 0
Assoc Professor BJ Coventry
Address [1] 697 0
Country [1] 697 0
Secondary sponsor category [2] 698 0
Individual
Name [2] 698 0
Professor D Morton
Address [2] 698 0
Country [2] 698 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2093 0
Royal Adelaide Hospital/University of Adelaide
Ethics committee address [1] 2093 0
Ethics committee country [1] 2093 0
Australia
Date submitted for ethics approval [1] 2093 0
Approval date [1] 2093 0
Ethics approval number [1] 2093 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35766 0
Address 35766 0
Country 35766 0
Phone 35766 0
Fax 35766 0
Email 35766 0
Contact person for public queries
Name 9721 0
Ms Nicki Bator
Address 9721 0
Adelaide Melanoma Unit
Department of Surgery
University of Adelaide
Royal Adelaide Hospital
L5 Eleanor Harrold Building (EHB)
North Terrace
Adelaide SA 5000
Country 9721 0
Australia
Phone 9721 0
+61 8 82224154
Fax 9721 0
+61 8 82225896
Email 9721 0
nbator@mail.rah.sa.gov.au
Contact person for scientific queries
Name 649 0
Associate Professor Brendan Coventry
Address 649 0
Adelaide Melanoma Unit
Department of Surgery
University of Adelaide
Royal Adelaide Hospital
L5 Eleanor Harrold Building (EHB)
North Terrace
Adelaide SA 5000
Country 649 0
Australia
Phone 649 0
+61 8 8222 4154
Fax 649 0
+61 8 8222 5896
Email 649 0
bcoventry@medicine.adelaide.edu.au

No information has been provided regarding IPD availability


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.