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

Not Applicable

Recruiting

• Conditions: Cutaneous head and neck squamous cell carcinoma; Cancer - Head and neck

• Registration Number: ACTRN12611001159943
• Lead Sponsor: Sydney Head and Neck Cancer Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
death from disease (disease specific survival)[5 years]

Secondary Outcome Measures

Name	Time	Method
recurrence in the ipsilateral parotid or neck as assessed by clinical examination +- ultrasound of the neck[5 years];facial or accessory nerve injury or sacrifice from the recurrence itself or its subsequent treatment as assessed by clinical examination[5 years]