Surgery without radiotherapy as treatment for low risk cutaneous head and neck squamous cell carcinoma

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611001159943

Acronym

SAILS Trial: Surgery Alone in Low-risk cutaneous SCC

Enrollment

Registered

2011-11-04

Start date

2011-11-25

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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].

Interventions

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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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)

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

Outcome results