Time to Treatment and Disease-free Survival of Patients With High-risk Head-neck Cutaneous Squamous Cell Carcinoma

Trial Title: Time to Treatment and Disease-free Survival of Patients With High-risk Head-neck Cutaneous Squamous Cell Carcinoma

NCT ID: NCT05845632

Condition: Carcinoma, Squamous Cell
Skin Cancer
Carcinoma, Squamous Cell, Skin
Carcinoma, Squamous Cell of Head and Neck
Recurrence
Metastasis

Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Recurrence

Conditions: Keywords:
Disease free survival
Survival
Multicenter
Time to treatment
Waiting times

Study type: Observational

Overall status: Active, not recruiting

Study design:

Time perspective: Retrospective

Intervention:

Intervention type: Other
Intervention name: Treatment
Description: Patients were treated with surgery, radiotherapy or surgery with postoperative radiotherapy.
Arm group label: Long time to treatment (30 days or more)
Arm group label: Short time to treatment (<30 days)

Summary: The purpose of this study is to investigate the association between time to treatment (defined as date of pathological diagnosis to date of start treatment) and disease free survival in patients with high risk cutaneous squamous cell carcinoma in the head-neck region.

Detailed description: Skin cancer is the most common type of cancer in the Netherlands. Cutaneous squamous cell carcinoma (cSCC) accounts for 20% of all cutaneous malignancies. The incidence of cSCC has been rising over the years in the Netherlands, from 8,966 new cSCCs cases registered in 2012 to 14,873 cases in 2022. cSCCs mostly involve patients aged 75 years and older. Since exposure to UV radiation is the main risk factor for the development, cSCCs particularly occur on sun exposed areas of the skin such as in the head-neck region and the extremities. Other risk factors include a Fitzpatrick skin type I or II, use of immunosuppression, exposure to arsenic, and infection with human papilloma virus. Risk of metastasis and recurrence in general cSCCs are 2.6-5% and 1.9-3.7%, respectively. However, these risk ratios may increase to 37% in high-risk cSCCs. High risk cSCCs are defined as cSCCs with risk factors for development of metastatic disease or recurrence, e.g. poor histological differentiation, perineural/lymphovascular infiltration, diameter ≥20 mm. Due to the increasing incidence, advanced age, risk of metastasis and recurrence, and the high risk-location in the head-neck region related to functional and cosmetic importance, high-risk cSCCs in the head-neck region (high-risk HNcSCCs) require complex and multidisciplinary care. Therefore, care pathways have been developed. An important part of these care pathways are waiting times and, in particular, the time to treatment. For example, in mucosal head-neck tumors, prolonged waiting times have been described to be associated with reduced survival rates. This led to the hypothesis that prolonged waiting times result result in lower survival rates for patients with high-risk HNcSCCs. This study aimed to investigate the association between time to treatment defined as date of pathological diagnosis to date of start treatment) and disease free survival in patients with high risk HNcSCCs.

Criteria for eligibility:

Study pop:
Pathology reports of patients, aged 18 years or older, diagnosed with a T2 to T4 high-risk HNcSCC, treated in the MUMC+ or Radboud UMC between 2010 and 2018, will be obtained from the Pathological Anatomical National Automated Archive (PALGA).

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: - Patient diagnosed with high-risk HNcSCCs, defined as T2 to T4 HNcSCC - Treated in the Maastricht University Medical Center+ (MUMC+) or Radboud University Medical Center (RadboudUMC) - Treated between 2010 to 2018 Exclusion Criteria: - Patients aged younger than 18 years - Patients with a T1 HNcSCC - Patients with recurrence or metastatic disease of a previously treated HNcSCC

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Maastricht University Medical Center+

Address:
City: Maastricht
Country: Netherlands

Facility:
Name: Radboud University Medical Center

Address:
City: Nijmegen
Country: Netherlands

Start date: January 1, 2022

Completion date: October 1, 2023

Lead sponsor:
Agency: Maastricht University Medical Center
Agency class: Other

Source: Maastricht University Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05845632
http://iknl.nl/kankersoorten/huidkanker/registratie/incidentie