T1 Squamous Cell Carcinomas of the Lip

August 15, 2023 updated by: Maastricht University Medical Center

Tumor Free Survival in T1 Squamous Cell Carcinomas of the Lip Treated With 5mm or 10mm Surgical Margins.

The purpose of this study is to investigate the risk of recurrence and metastasis in patients treated with different surgical margins (5mm vs 10mm) for a T1 squamous cell carcinoma of the lip.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

The incidence of head and neck tumors, including lip carcinomas, in increasing. Exact incidences are lacking because in the Dutch National Cancer Registry (NCR) lip carcinomas are registered both as oral cavity carcinomas and skin carcinomas. In 2021, 136 patients with lip cancer were registered in the Netherlands. 90% of patients with lip cancer have localized disease (stage 1) with a 5-year survival rate of more than 90%.

Lip carcinomas usually involve squamous cell carcinomas (SCC). In most cases, the SCC is located on the sun-exposed lower lip. In approximately 90% of lower lip SCCs, the tumor is smaller than 2cm in diameter. According to the current eight edition of the Tumor Node Metastasis (TNM) classification of the American Joint Committee on Cancer (AJCC) and the ninth edition of the Union for Internation Cancer Control (UICC), it is classified as tumor stage I.

Surgery is the conventional treatment for a T1 SCC of the lip, where tumor margins can be verified via histologic examination. A histologic margin of less than 2mm is associated with an increased risk of local recurrence and metastasis.

In the Netherlands, surgical treatment of lip carcinomas is performed by dermatologists, plastic and reconstruction surgeons, oral and maxillofacial surgeons (OMFS), and otorhinolaryngologists (ENT). There is currently no international consensus regarding the appropriate surgical margins for excision of a T1 SCC on the lip. According to the AJCC, a surgical margin of 5mm is appropriate, while according to the UICC, a surgical margin of 10mm is appropriate. Scientific evidence is limited regarding differences in tumor clearance and the risk of recurrence or metastasis after excision of T1 SCCs with a surgical margin of 5mm versus 10mm.

We aimed to investigate whether there is a significant difference in tumor-free survival in patients with surgically treated T1 lip SCC with a surgical margin of 5mm versus 10mm.

A retrospective descriptive multicenter data study will be conducted with four different centers in the Netherlands (Maastricht University Medical Center+), Radboud University Medical Center (RadboudUMC) Nijmegen, Catharina Hospital Eindhoven (CZE), and Zuyderland Medical Center Heerlen/Sittard. Data will be obtained from the Dutch Cancer Registry (NKR) and the Dutch Pathological Anatomical National Automated Archive (PALGA).

The primary outcome is the difference in tumor-free survival in patients treated with surgical margins of 5mm and 10mm. The secondary outcome is the difference in tumor-free survival in patients with different histologic free margins. To evaluate the risk of surgical and histologic margins on the risk of local recurrence and metastasis, a Kaplan-Meier analysis, log-rank test and cox-proportional hazard models will be used.

Study Type

Observational

Enrollment (Estimated)

300

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
      • Eindhoven, Netherlands
        • Catharina Hospital
      • Heerlen, Netherlands
        • Zuyderland Medical Center
    • Gelderland
      • Nijmegen, Gelderland, Netherlands
        • Radboud UMC

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Data from patients are collected retrospectively using data from the Pathological Anatomical National Automated Archive (PALGA). These are data from patients treated at one of the following four centers in the Netherlands: MUMC+, Radboudumc, Zuyderland MC, CZE.

Description

Inclusion Criteria:

  • patients of 18 years and older
  • with a T1 cutaneous squamous cell carcinoma of the lip (including the cutaneous lip, vermillion border, vermillion and mucosal involvement).
  • who received surgical treatment
  • treated at one of the following centers: Maastricht University Medical Center+ (MUMC+), Radboud University Medical Center (Radboudumc), Zuyderland Medical Center (Zuyderland MC), Catharina Hospital Eindhoven (CZE).

Exclusion Criteria:

  • malignancies other than cutaneous squamous cell carcinoma
  • Oropharyngeal cancer
  • patients with stage T2-T4 cutaneous squamous cell caricnomas of the lip

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
5mm surgical margin
Patients treated with a 5mm surgical margin for a T1 SCC of the lip.
10mm surgical margin
Patients treated with a 10mm surgical margin for a T1 SCC of the lip.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor-free survival surgical margins
Time Frame: 5 years after surgical treatment
Difference in tumor-free survival of patients treated with a 5mm surgical margin versus 10mm surgical margin for a T1 SCC on the lip. An event was refered to as the occurrence of recurrence or metastasis.
5 years after surgical treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor-free survival histologic margins
Time Frame: 5 years after surgical treatment
Difference in tumor-free survival of patients with a histologic margin of <2mm versus patients with a histologic margin of 2mm or more of their T1 SCC on the lip.
5 years after surgical 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: K Mosterd, 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)

April 1, 2021

Primary Completion (Actual)

July 1, 2023

Study Completion (Estimated)

November 1, 2023

Study Registration Dates

First Submitted

November 2, 2022

First Submitted That Met QC Criteria

November 2, 2022

First Posted (Actual)

November 9, 2022

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

  • 2022-2224-A-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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