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

Skin Cancer Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05845632
• Other study ID #: 2021-2885-A-2
• Status: Active, not recruiting
• Start date: January 1, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: August 2023
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 965
• Est. completion date: October 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Treatment
Patients were treated with surgery, radiotherapy or surgery with postoperative radiotherapy.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center+	Maastricht
Netherlands	Radboud University Medical Center	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (19)

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* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association time to treatment and survival	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.	5 years after treatment
Secondary	5 year disease free survival between short and long time to 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 years after treatment
Secondary	5 year disease specific survival between short and long time to 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 years after treatment
Secondary	5 year overall survival between short and long time to 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 years after treatment
Secondary	5 year disease free survival between participating centers	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 years after treatment
Secondary	5 year disease specific survival between participating centers	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 years after treatment
Secondary	5 year overall survival between participating centers	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.	5 years after treatment

External Links

•   Integral cancer center Netherlands; incidence rates on cutaneous squamous cell carcinomas