Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000713998
Ethics application status
Approved
Date submitted
7/06/2011
Date registered
11/07/2011
Date last updated
11/07/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A Prospective randomised trial of sentinel node biopsy for high risk non-melanoma skin cancer.
Scientific title
A phase III Multicenter Randomised Trial in High Risk Non Melanoma Skin Cancer of Sentinel Lymph Node Biopsy and Lymphadenectomy versus Nodal Observation on Disease Free and Overall Survival.
Secondary ID [1] 262164 0
Nil
Universal Trial Number (UTN)
U1111-1118-3627
Trial acronym
SNIC trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non melanoma skin cancer 265850 0
Condition category
Condition code
Cancer 266004 266004 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Wide local excision of the primary site and Sentinel lymph node biopsy (SLNB) with completion lymphadenectomy (second procedure at later date) for histopathologically positive sentinel nodes.
Both sentinel node positive and sentinel node negative patients will receive 5 years follow up and continuing observation of lymphatic basin for metastasis.
Intervention code [1] 264576 0
Treatment: Surgery
Intervention code [2] 266937 0
Early detection / Screening
Intervention code [3] 266938 0
Diagnosis / Prognosis
Comparator / control treatment
Wide local excision of primary and observation of regional lymph nodes 5 years follow up.
Patients that develop clinically apparent nodal metastases during observation will then receive completion lymphadenectomy.

All trial patients will be reviewed every 4 months for the first 2 years, and then every 6 months for the remaining 3 years. Nodal ultrasound +/- fine needle aspiration biopsy will be performed if clinical suspicion of nodal metastasis at any stage in both groups.
Control group
Active

Outcomes
Primary outcome [1] 266745 0
Disease free survival.

Disease-free survival is the time from the patient's randomisation to treatment group until the date of diagnosis of recurrent disease in the local regional lymph nodes, or distant metastases.
Timepoint [1] 266745 0
All subjects all followed until death, or at least 5 years. Follow up intervals are every 4 months for the first 2 years, the every 6 months for the remaining 3 years.
Primary outcome [2] 268993 0
Overall survival.

Overall survival is the time from the patient's randomisation of treatment to the date of death from any cause.
Timepoint [2] 268993 0
All subjects all followed until death, or at least 5 years. Follow up intervals are every 4 months for the first 2 years, the every 6 months for the remaining 3 years.
Secondary outcome [1] 276295 0
Disease-specific survival.

This is the time from the patient's randomisation until the date of the patients death due to non melanoma skin cancer.
Timepoint [1] 276295 0
All subjects all followed until death, or at least 5 years. Follow up intervals are every 4 months for the first 2 years, the every 6 months for the remaining 3 years.
Secondary outcome [2] 276296 0
Quality of life in both patient groups will be assessed using the QOL tools EORTC QLQ-H&N35 and EORTC QLQ-C30.
Timepoint [2] 276296 0
Patients in both groups will be asked to complete quality of life questionnaires prior to randomisation, and at the 4 months and yearly after their surgery until 5 years reached.

Mean individual changes in quality of life will be compared between treatment arms.

Eligibility
Key inclusion criteria
Participants must be able to give fully informed consent and have non melanoma skin cancer with any of the following clinicopathologic risk factors:
-size > 2cm
-invasion into subcutaneous fat or tumour thickness > 5mm
-poorly differentiated phenotype
-perineural invasion
-lymphovascular invasion
-local recurrence
-location of lesion on lip or ear
-immunocomprimised host (post organ transplant, chemotherapy)
-carcinoma developing in pre-existing scar
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects meeting any of the following criteria will be excluded from participation:
-Clinical evidence of distant metastases
-previous surgery that is believed to have altered the local lymphatic drainage since emergence of lesion
-allergy to patent blue dye or radiocolloid
-significant cognitive or psychiatric disorder (inability to understand informed consent)
-pregnancy/lactation
-inability to complete 5 years of follow up
-Participation in concurrent experimental protocols or alternative therapies that might confound the analysis of this trial. Adjuvant therapy protocols after recurrence are acceptable.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random permuted variable size block design
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment outside Australia
Country [1] 3587 0
New Zealand
State/province [1] 3587 0
Country [2] 3588 0
Canada
State/province [2] 3588 0

Funding & Sponsors
Funding source category [1] 267283 0
Charities/Societies/Foundations
Name [1] 267283 0
Sydney Head and Neck Cancer Institute
Country [1] 267283 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Sydney Head and Neck Cancer Institute
Address
PO Box 142
Missenden Road
Camperdown
NSW 2050
Country
Australia
Secondary sponsor category [1] 264161 0
None
Name [1] 264161 0
Nil
Address [1] 264161 0
Country [1] 264161 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267050 0
Sydney Local Health Network Ethics Review Committee (RPAH zone)
Ethics committee address [1] 267050 0
c/- Research Development Office
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Ethics committee country [1] 267050 0
Australia
Date submitted for ethics approval [1] 267050 0
11/11/2009
Approval date [1] 267050 0
03/12/2009
Ethics approval number [1] 267050 0
HREC/09RPAH/547

Summary
Brief summary
This study aims to determine the effect of sentinel lymph node biopsy on survival in people with high risk non melanoma skin cancer.

Who is it for?
You can join this study if you are aged 18 years or more, have high risk non melanoma skin cancer, and will be available for a 5 year follow-up assessment.

Trial details
Participants in this trial will be randomly (by chance) allocated to one of two groups. Both groups will undergo removal of their skin cancer. In addition, participants in one group will receive sentinel lymph node biopsy. This is a procedure in which the local lymph node ("gland") that drain the patch of skin containing the tumour are excised. These lymph node(s) are examined under a microscope to determine whether cancer cells are present. If cancer cells are found, patients will undergo completion lymphadenectomy (i.e. surgical removal of the rest of the regional lymph nodes).
Participants in the second group will undergo observation of regional lymph nodes, and those that develop cancer cells will undergo completion lymphadenectomy.

All patients will undergo continued observation for a period of 5 years to determine survival and quality of life.
Trial website
http://www.shnci.org/Pages/research03.html
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32605 0
Address 32605 0
Country 32605 0
Phone 32605 0
Fax 32605 0
Email 32605 0
Contact person for public queries
Name 15852 0
Sarah Davies
Address 15852 0
Sydney Head and Neck Cancer Institute
PO Box M142
Missenden Road
Camperdown
NSW 2050
Country 15852 0
Australia
Phone 15852 0
61 2 9515 7535
Fax 15852 0
61 2 9515 7483
Email 15852 0
[email protected]
Contact person for scientific queries
Name 6780 0
Jonathan Clark
Address 6780 0
Sydney Head and Neck Cancer Institute
PO Box M142
Missenden Road
Camperdown
NSW 2050
Country 6780 0
Australia
Phone 6780 0
61 2 9553 8827
Fax 6780 0
61 2 9515 7483
Email 6780 0
[email protected]

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.