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

Sponsor

Maastricht University Medical Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05845632

Collaborator

(none)

965

Enrollment

Locations

Anticipated Duration (Months)

482.5

Patients Per Site

28.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Squamous Cell Skin Cancer Carcinoma, Squamous Cell, Skin Carcinoma, Squamous Cell of Head and Neck Recurrence Metastasis	Other: Treatment

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

965 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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.

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Short time to treatment (<30 days) Patients with high-risk HNcSCC with a time to treatment (date of pathological diagnosis to date of start treatment) of less than 30 days.	Other: Treatment Patients were treated with surgery, radiotherapy or surgery with postoperative radiotherapy.
Long time to treatment (30 days or more) Patients with high-risk HNcSCC with a time to treatment (date of pathological diagnosis to date of start treatment) of 30 days or more.	Other: Treatment Patients were treated with surgery, radiotherapy or surgery with postoperative radiotherapy.

Arm

Intervention/Treatment

Short time to treatment (<30 days)

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

Other: Treatment

Patients were treated with surgery, radiotherapy or surgery with postoperative radiotherapy.

Long time to treatment (30 days or more)

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

Other: Treatment

Patients were treated with surgery, radiotherapy or surgery with postoperative radiotherapy.

Outcome Measures

Primary Outcome Measures

Association time to treatment and survival [5 years after treatment]
The association between time to treatment (in days) and disease-free survival (e.g. no recurrence or metastasis occurred), expressed as adjusted hazard ratio with 95% confidence intervals and p values, from multivariate Cox regression analysis.

Secondary Outcome Measures

5 year disease free survival between short and long time to treatment [5 years after treatment]
5 year cumulative probability of disease free survival in patients with a short (<30 days) versus long (30 days or more) time to treatment, presented as percentages with 95% confidence intervals and p-values using Kaplan Meier survival curves and the log-rank test.
5 year disease specific survival between short and long time to treatment [5 years after treatment]
5 year cumulative probability of disease specific survival in patients with a short (<30 days) versus long (30 days or more) time to treatment, presented as percentages with 95% confidence intervals and p-values using Kaplan Meier survival curves and the log-rank test.
5 year overall survival between short and long time to treatment [5 years after treatment]
5 year cumulative probability of overall survival in patients with a short (<30 days) versus long (30 days or more) time to treatment, presented as percentages with 95% confidence intervals and p-values using Kaplan Meier survival curves and the log-rank test.
5 year disease free survival between participating centers [5 years after treatment]
5 year cumulative probability of disease free survival in patients treated at the Maastricht University Medical Center+ versus Radboud University Medical Center, presented as percentages with 95% confidence intervals and p-values using Kaplan Meier survival curves and the log-rank test.
5 year disease specific survival between participating centers [5 years after treatment]
5 year cumulative probability of disease specific survival in patients treated at the Maastricht University Medical Center+ versus Radboud University Medical Center, presented as percentages with 95% confidence intervals and p-values using Kaplan Meier survival curves and the log-rank test.
5 year overall survival between participating centers [5 years after treatment]
5 year cumulative probability of overall survival in patients treated at the Maastricht University Medical Center+ versus Radboud University Medical Center, presented as percentages with 95% confidence intervals and p-values using Kaplan Meier survival curves and the log-rank test.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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