Clinical trial NCT05845632: Time to Treatment and Disease-free Survival of Patients With High-risk Head-neck Cutaneous Squamous Cell Carcinoma
Official title: Association Between Time to Treatment and Disease-free Survival of Patients With High-risk Cutaneous Squamous Cell Carcinoma in the Head and Neck Region.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Carcinoma, Squamous Cell
Skin Cancer
Carcinoma, Squamous Cell, Skin
Carcinoma, Squamous Cell of Head and Neck
Recurrence
Metastasis
Keywords: Disease free survival
Survival
Multicenter
Time to treatment
Waiting times
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 965
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

Brief 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.

Eligibility 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

Primary outcomes:
measure: Association time to treatment and survival
timeFrame: 5 years after treatment
Secondary outcomes:
measure: 5 year disease free survival between short and long time to treatment
timeFrame: 5 years after treatment
measure: 5 year disease specific survival between short and long time to treatment
timeFrame: 5 years after treatment
measure: 5 year overall survival between short and long time to treatment
timeFrame: 5 years after treatment
measure: 5 year disease free survival between participating centers
timeFrame: 5 years after treatment
measure: 5 year disease specific survival between participating centers
timeFrame: 5 years after treatment
measure: 5 year overall survival between participating centers
timeFrame: 5 years after treatment
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center+
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
Study officials:
affiliation: Maastricht University Medical Center
name: N Kelleners-Smeets, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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