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

August 15, 2023 updated by: Maastricht University Medical Center

Association Between Time to Treatment and Disease-free Survival of Patients With High-risk Cutaneous Squamous Cell Carcinoma in the Head and Neck Region.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / 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 Type

Observational

Enrollment (Estimated)

965

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands
        • Maastricht University Medical Center+
      • Nijmegen, Netherlands
        • Radboud University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association time to treatment and survival
Time Frame: 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.
5 years after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5 year disease free survival between short and long time to treatment
Time Frame: 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 years after treatment
5 year disease specific survival between short and long time to treatment
Time Frame: 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 years after treatment
5 year overall survival between short and long time to treatment
Time Frame: 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 years after treatment
5 year disease free survival between participating centers
Time Frame: 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 years after treatment
5 year disease specific survival between participating centers
Time Frame: 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 years after treatment
5 year overall survival between participating centers
Time Frame: 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.
5 years after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: N Kelleners-Smeets, MD, PhD, Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

May 1, 2023

Study Completion (Estimated)

October 1, 2023

Study Registration Dates

First Submitted

April 17, 2023

First Submitted That Met QC Criteria

April 26, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

August 16, 2023

Last Update Submitted That Met QC Criteria

August 15, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-2885-A-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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