Clinical trial · Observational
T1 Squamous Cell Carcinomas of the Lip
Tumor Free Survival in T1 Squamous Cell Carcinomas of the Lip Treated With 5mm or 10mm Surgical Margins.
NCT05610293CI-TRIAL-00068868unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lip | — | UNRESOLVED | — |
| Lip Cancer | Malignant Lip Neoplasm | ALIAS | 0.90 |
| Lip SCC | Lip Squamous Cell Carcinoma | ALIAS | 0.90 |
| Metastasis | — | UNRESOLVED | — |
| Recurrence | — | UNRESOLVED | — |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Squamous Cell Carcinoma of the Lip | Lip Squamous Cell Carcinoma | ALIAS | 0.90 |
| Surgery | — | UNRESOLVED | — |
| Surgical Margin | — | UNRESOLVED | — |
| Tumor Free Margins | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- 5mm surgical margin
- description
- Patients treated with a 5mm surgical margin for a T1 SCC of the lip.
- label
- 10mm surgical margin
- description
- Patients treated with a 10mm surgical margin for a T1 SCC of the lip.
Primary outcomes (1)
- measure
- Tumor-free survival surgical margins
- timeFrame
- 5 years after surgical treatment
- description
- 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.
Secondary outcomes (1)
- measure
- Tumor-free survival histologic margins
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDKerawala 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
- BACKGROUNDde 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
- BACKGROUNDKelleners-Smeets NW, Bekkenk MW, de Haas ER. [Skin cancer: from smearing to cutting]. Ned Tijdschr Geneeskd. 2013;157(12):A5602. Dutch. PMID 23515035
- BACKGROUNDBiasoli 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
- BACKGROUNDde 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
- BACKGROUNDJoo 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
- BACKGROUNDO'Sullivan B. UICC manual of clinical oncology: John Wiley & Sons; 2015.