A Prospective randomised trial of sentinel node biopsy for high risk non-melanoma skin cancer.

Not Applicable

• Conditions: on melanoma skin cancer; Non melanoma skin cancer; Cancer - Non melanoma skin cancer

• Registration Number: ACTRN12611000713998
• 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: 2011-07-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 300

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease free survival. <br><br>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.[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.];Overall survival.<br><br>Overall survival is the time from the patient's randomisation of treatment to the date of death from any cause.[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 Measures

Name	Time	Method
Disease-specific survival.<br><br>This is the time from the patient's randomisation until the date of the patients death due to non melanoma skin cancer.[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.];Quality of life in both patient groups will be assessed using the QOL tools EORTC QLQ-H&N35 and EORTC QLQ-C30.[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.<br><br>Mean individual changes in quality of life will be compared between treatment arms.]