Clinical trial · Observational
Time to Treatment and Disease-free Survival of Patients With High-risk Head-neck Cutaneous Squamous Cell Carcinoma
Association Between Time to Treatment and Disease-free Survival of Patients With High-risk Cutaneous Squamous Cell Carcinoma in the Head and Neck Region.
NCT05845632CI-TRIAL-00068849unknownClinicalTrials.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 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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Squamous Cell | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Carcinoma, Squamous Cell of Head and Neck | Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Carcinoma, Squamous Cell, Skin | Skin Squamous Cell Carcinoma | ALIAS | 0.90 |
| Metastasis | — | UNRESOLVED | — |
| Recurrence | — | UNRESOLVED | — |
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Treatment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Short time to treatment (<30 days)
- description
- Patients with high-risk HNcSCC with a time to treatment (date of pathological diagnosis to date of start treatment) of less than 30 days.
- interventionNames
- Other: Treatment
- label
- Long time to treatment (30 days or more)
- description
- Patients with high-risk HNcSCC with a time to treatment (date of pathological diagnosis to date of start treatment) of 30 days or more.
- interventionNames
- Other: Treatment
Primary outcomes (1)
- measure
- Association time to treatment and survival
- timeFrame
- 5 years after treatment
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (19)
- BACKGROUNDFania L, Didona D, Di Pietro FR, Verkhovskaia S, Morese R, Paolino G, Donati M, Ricci F, Coco V, Ricci F, Candi E, Abeni D, Dellambra E. Cutaneous Squamous Cell Carcinoma: From Pathophysiology to Novel Therapeutic Approaches. Biomedicines. 2021 Feb 9;9(2):171. doi: 10.3390/biomedicines9020171. PMID 33572373
- BACKGROUNDKallini JR, Hamed N, Khachemoune A. Squamous cell carcinoma of the skin: epidemiology, classification, management, and novel trends. Int J Dermatol. 2015 Feb;54(2):130-40. doi: 10.1111/ijd.12553. Epub 2014 Nov 27. PMID 25428226
- BACKGROUNDQue SKT, Zwald FO, Schmults CD. Cutaneous squamous cell carcinoma: Incidence, risk factors, diagnosis, and staging. J Am Acad Dermatol. 2018 Feb;78(2):237-247. doi: 10.1016/j.jaad.2017.08.059. PMID 29332704
- BACKGROUNDStern RS; PUVA Follow-Up Study. The risk of squamous cell and basal cell cancer associated with psoralen and ultraviolet A therapy: a 30-year prospective study. J Am Acad Dermatol. 2012 Apr;66(4):553-62. doi: 10.1016/j.jaad.2011.04.004. Epub 2012 Jan 20. PMID 22264671
- BACKGROUNDStratigos AJ, Garbe C, Dessinioti C, Lebbe C, Bataille V, Bastholt L, Dreno B, Fargnoli MC, Forsea AM, Frenard C, Harwood CAlpha, Hauschild A, Hoeller C, Kandolf-Sekulovic L, Kaufmann R, Kelleners-Smeets NW, Malvehy J, Del Marmol V, Middleton MR, Moreno-Ramirez D, Pellecani G, Peris K, Saiag P, van den Beuken-van Everdingen MHJ, Vieira R, Zalaudek I, Eggermont AMM, Grob JJ; European Dermatology Forum (EDF), the European Association of Dermato-Oncology (EADO) and the European Organization for Research and Treatment of Cancer (EORTC). European interdisciplinary guideline on invasive squamous cell carcinoma of the skin: Part 1. epidemiology, diagnostics and prevention. Eur J Cancer. 2020 Mar;128:60-82. doi: 10.1016/j.ejca.2020.01.007. Epub 2020 Feb 26. PMID 32113941
- BACKGROUNDPhung D, Ahmadi N, Gupta R, Clark JR, Wykes J, Ch'ng S, Elliott MS, Palme CE, Shannon K, Wu R, Lee JH, Low TH. Survival outcomes of perineural spread in head and neck cutaneous squamous cell carcinoma. ANZ J Surg. 2022 Sep;92(9):2299-2304. doi: 10.1111/ans.17908. Epub 2022 Jul 22.