T1 Squamous Cell Carcinomas of the Lip

NCT05610293 | Unknown

• 1 other identifier: 2022-2224-A-2
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Lip; Lip Cancer; Lip SCC; Squamous Cell Carcinoma; Squamous Cell Carcinoma of the Lip; Surgery; Surgical Margin; Recurrence; Metastasis; Tumor Free Margins

Keywords

Disease free survival; Multicenter; Histological margin

Outcome Measures

Primary Outcomes (1)

• Tumor-free survival surgical margins

  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 Outcomes (1)

• Tumor-free survival histologic margins

  5 years after surgical treatment

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (3)

Radboud UMC

Nijmegen, Gelderland, Netherlands

Location

Catharina Hospital

Eindhoven, Netherlands

Location

Zuyderland Medical Center

Heerlen, Netherlands

Location

Related Publications (7)

• Kerawala C, Roques T, Jeannon JP, Bisase B. Oral cavity and lip cancer: United Kingdom National Multidisciplinary Guidelines. J Laryngol Otol. 2016 May;130(S2):S83-S89. doi: 10.1017/S0022215116000499.

  PMID: 27841120 BACKGROUND

• de Visscher JG, Grond AJ, Botke G, van der Waal I. Results of radiotherapy for squamous cell carcinoma of the vermilion border of the lower lip. A retrospective analysis of 108 patients. Radiother Oncol. 1996 Apr;39(1):9-14. doi: 10.1016/0167-8140(96)01716-1.

  PMID: 8735488 BACKGROUND

• Kelleners-Smeets NW, Bekkenk MW, de Haas ER. [Skin cancer: from smearing to cutting]. Ned Tijdschr Geneeskd. 2013;157(12):A5602. Dutch.

  PMID: 23515035 BACKGROUND

• Biasoli ER, Valente VB, Mantovan B, Collado FU, Neto SC, Sundefeld ML, Miyahara GI, Bernabe DG. Lip Cancer: A Clinicopathological Study and Treatment Outcomes in a 25-Year Experience. J Oral Maxillofac Surg. 2016 Jul;74(7):1360-7. doi: 10.1016/j.joms.2016.01.041. Epub 2016 Jan 30.

  PMID: 26917204 BACKGROUND

• de Visscher JG, Gooris PJ, Vermey A, Roodenburg JL. Surgical margins for resection of squamous cell carcinoma of the lower lip. Int J Oral Maxillofac Surg. 2002 Apr;31(2):154-7. doi: 10.1054/ijom.2002.0232.

  PMID: 12102412 BACKGROUND

• Joo YH, Cho JK, Koo BS, Kwon M, Kwon SK, Kwon SY, Kim MS, Kim JK, Kim H, Nam I, Roh JL, Park YM, Park IS, Park JJ, Shin SC, Ahn SH, Won S, Ryu CH, Yoon TM, Lee G, Lee DY, Lee MC, Lee JK, Lee JC, Lim JY, Chang JW, Jang JY, Chung MK, Jung YS, Cho JG, Choi YS, Choi JS, Lee GH, Chung PS. Guidelines for the Surgical Management of Oral Cancer: Korean Society of Thyroid-Head and Neck Surgery. Clin Exp Otorhinolaryngol. 2019 May;12(2):107-144. doi: 10.21053/ceo.2018.01816. Epub 2019 Feb 2.

  PMID: 30703871 BACKGROUND

• O'Sullivan B. UICC manual of clinical oncology: John Wiley & Sons; 2015.

  BACKGROUND

Related Links

• Integral cancer center Netherlands; incidence rates on lip tumors

MeSH Terms

Conditions

Lymphoid Interstitial Pneumonia; Lip Neoplasms; Carcinoma, Squamous Cell; Margins of Excision; Recurrence; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes; Neoplastic Processes

Study Officials

• K Mosterd, MD, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 9, 2022
• Study Start: April 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: November 1, 2023
• Last Updated: August 16, 2023

Record last verified: 2023-08

Locations

NL (3)