Surgical Treatment of Stage T3 Squamous Cell Carcinomas of the Scalp

Surgery Clinical Trial

Official title:

Surgical Treatment of Stage T3 Squamous Cell Carcinomas of the Scalp

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05987579
• Other study ID #: 2021-2706
• Status: Active, not recruiting
• Start date: May 3, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: April 2024
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study examines tumor- en surgical characteristics of stage T3 cutaneous squamous cell carcinomas on the scalp, diagnosed between 2010 and 2018. Histological data and patient- and tumor characteristics were collected.

Description:

Cutaneous squamous cell carcinoma is the second most common type of non-melanoma skin cancer, following basal cell carcinoma. Following the American Joint Committee on Cancer Tumour, Node and Metastasis (TNM) Classification of Malignant Tumors staging system (TNM8), T3 cutaneous squamous cell carcinomas comprise an interesting group, especially on the scalp, because of the thin subcutaneous fat layer. According to the TNM8 criteria, T3 include all cutaneous squamous cel carcinomas with greatest tumor dimension ≥4cm, tumors with minimal bone erosion or perineural growth (defined as involvement of the nerve sheath of a nerve lying deeper than the dermis or measuring 0.1mm or larger in caliber or showing clinical or radiographic involvement of nerves without invasion of the skull base) or with deep invasion. Deep invasion is defined as invasion deeper than the subcutaneous fat or a tumor thickness >6mm. The scalp has a natural anatomical and oncological barrier for extension in depth known as the epicranial aponeurosis, also called the galea aponeurotica.

This retrospective study, examines the tumor- en surgical characteristics of these stage T3 cutaneous squamous cell carcinomas on the scalp.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 104
• Est. completion date: December 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• stage T3 cutaneous squamous cell carcinoma of the scalp (histologically proven)

• surgical treatment or radiotherapy treatment

Exclusion Criteria:

• metastasis by diagnosis

• stage T1/T2/T4

Related Conditions & MeSH terms

• Cancer Head Neck
• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Squamous Cell Carcinoma
• Surgery

Locations

Country	Name	City	State
Netherlands	Ellen Oyen	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Amin MB, Greene FL, Edge SB, Compton CC, Gershenwald JE, Brookland RK, Meyer L, Gress DM, Byrd DR, Winchester DP. The Eighth Edition AJCC Cancer Staging Manual: Continuing to build a bridge from a population-based to a more "personalized" approach to cancer staging. CA Cancer J Clin. 2017 Mar;67(2):93-99. doi: 10.3322/caac.21388. Epub 2017 Jan 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical characteristics	Choice of treatment, complications, reconstruction types	Between 2010-2017
Primary	Tumor characteristics	Histological data on invasion depth, tumor differentiation	Between 2010-2017
Primary	Patients characteristics	Risk factors, comorbidities	Between 2010-2017