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Trial registered on ANZCTR


Registration number
ACTRN12611001159943
Ethics application status
Approved
Date submitted
25/10/2011
Date registered
4/11/2011
Date last updated
8/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Surgery without radiotherapy as treatment for low risk cutaneous head and neck squamous cell carcinoma
Scientific title
Low-Risk Nodal Metastases from Cutaneous Head and Neck Squamous Cell Carcinoma: : a prospective trial evaluating the effect of single modality treatment with surgery on disease specific survival
Secondary ID [1] 273266 0
Nil
Universal Trial Number (UTN)
Trial acronym
SAILS Trial: Surgery Alone in Low-risk cutaneous SCC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cutaneous head and neck squamous cell carcinoma 279032 0
Condition category
Condition code
Cancer 279218 279218 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Surgical treatment without additional radiotherapy. Surgical treatment consists of the resection of relevent lymph node levels of the neck including those in the parotid gland. The procedure can take from 90 to 240 minutes.
Intervention code [1] 269609 0
Treatment: Surgery
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279851 0
death from disease (disease specific survival)
Timepoint [1] 279851 0
5 years
Secondary outcome [1] 294578 0
recurrence in the ipsilateral parotid or neck as assessed by clinical examination +- ultrasound of the neck
Timepoint [1] 294578 0
5 years
Secondary outcome [2] 294579 0
facial or accessory nerve injury or sacrifice from the recurrence itself or its subsequent treatment as assessed by clinical examination
Timepoint [2] 294579 0
5 years

Eligibility
Key inclusion criteria
previously untreated cutaneous head and neck squamous cell
carcinoma

Pathology stage 1 of N1S3 (single node less than or equal to 3cm)

Treated with curative intent

Appropriate neck dissection based on location of the nodal metastasis and primary tumour plus/minus lymphoscintigraphy

Pre-operative PET scan is encouraged to ensure no nodal disease outside planned surgical dissection field (this will be left to the discretion of the treating clinician)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prior to inclusion in the study the clinician must ensure the tumour is low-risk. This should include a review of the pathology and discussion with colleagues within a multidisciplinary team meeting.

Exclusion criteria include adverse clinicopathological features according to the ITEM prognostic score
Immunosuppression
Extracapsular nodal spread (or if the lesion is a soft tissue deposit)
Involved margins
or close margins with an infiltrating pattern of spread (cf encapsulated/pushing)

Also indications for radiotherapy for the primary tumour
Perineural or lymphovascular invasion

Additional exclusion criteria
Surgeon concern regarding tumour contamination of the operative field
Patient is unable or unwilling to attend follow up reliably
Clinical (Physical, radiological or pathological) evidence of distant metastases
Significant cognitive or psychiatric disorder (unable to understand informed consent)
Coexisting malignancy
Pregnancy/lactation

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)
Prior to inclusion in the study the clinician must ensure the tumour is low-risk. This should include a review of the pathology and discussion with colleagues within a multidisciplinary team meeting.
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 284097 0
Self funded/Unfunded
Name [1] 284097 0
Address [1] 284097 0
Country [1] 284097 0
Primary sponsor type
Charities/Societies/Foundations
Name
Sydney Head and Neck Cancer Institute
Address
The Chris O'Brien Lifehouse at RPA,
Missenden Road,
Camperdown, NSW, 2050
Country
Australia
Secondary sponsor category [1] 269059 0
None
Name [1] 269059 0
Address [1] 269059 0
Country [1] 269059 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272047 0
Sydney South West Area Health Service Human Research Ethics Committee (RPAH Zone) (EC 00113)
Ethics committee address [1] 272047 0
Research Development Office
RPAH
Missenden Road
Camperdown NSW 2050
Ethics committee country [1] 272047 0
Australia
Date submitted for ethics approval [1] 272047 0
Approval date [1] 272047 0
18/10/2011
Ethics approval number [1] 272047 0
HREC/11/RPAH/418

Summary
Brief summary
This study aims to determine the efficacy of surgery without radiotherapy as treatment for low risk cutaneous head and neck squamous cell carcinoma.

Who is it for?
You may be eligible to join this study if you are aged 18 years or more and have low-risk cutaneous head and neck squamous cell carcinoma for which you have previously received no treatment.

Trial details
All participants in this trial will undergo surgical treatment without additional radiotherapy. Surgical treatment includes removal of all relevant lymph nodes of the neck.


You will be assessed for a period of up to 5 years to determine disease specific survival, the incidence of recurrence and associated consequences [assessment will be done by regular clinical examinations plus/minus ultrasound].
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33307 0
A/Prof A/Prof Jonathan Clark
Address 33307 0
Level 5, Gloucester House,
Royal prince Alfred Hospital
Missenden Road,
Camperdown, NSW, 2050
Country 33307 0
Australia
Phone 33307 0
61295154019
Fax 33307 0
Email 33307 0
jcjc@tpg.com.au
Contact person for public queries
Name 16554 0
A/Prof A/Prof. Jonathan Clark
Address 16554 0
Level 5, Gloucester House,
Royal prince Alfred Hospital
Missenden Road,
Camperdown, NSW, 2050
Country 16554 0
Australia
Phone 16554 0
61295154019
Fax 16554 0
61295153179
Email 16554 0
jcjc@tpg.com.au
Contact person for scientific queries
Name 7482 0
A/Prof A/Prof. Jonathan Clark
Address 7482 0
Level 5, Gloucester House,
Royal prince Alfred Hospital
Missenden Road,
Camperdown, NSW, 2050
Country 7482 0
Australia
Phone 7482 0
61295154019
Fax 7482 0
61295153179
Email 7482 0
jcjc@tpg.com.au

No data has been provided for results reporting
Summary results
Not applicable