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

Maastricht University Medical Centre (MUMC)

Status: Active, not recruiting

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

Treatments: Other: Treatment

Study type: Observational

Funder types: Other

Identifiers

NCT05845632

2021-2885-A-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 965 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

965 participants in 2 patient groups

Short time to treatment (<30 days)

Description:

Patients with high-risk HNcSCC with a time to treatment (date of pathological diagnosis to date of start treatment) of less than 30 days.

Treatment:

Other: Treatment

Long time to treatment (30 days or more)

Description:

Patients with high-risk HNcSCC with a time to treatment (date of pathological diagnosis to date of start treatment) of 30 days or more.

Treatment:

Other: Treatment