NCT05845632

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
965

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2023

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

August 16, 2023

Status Verified

August 1, 2023

Enrollment Period

1.3 years

First QC Date

April 17, 2023

Last Update Submit

August 15, 2023

Conditions

Carcinoma, Squamous CellSkin CancerCarcinoma, Squamous Cell, SkinCarcinoma, Squamous Cell of Head and NeckRecurrenceMetastasis

Keywords

Disease free survivalSurvivalMulticenterTime to treatmentWaiting times

Outcome Measures

Primary Outcomes (1)

  • Association time to treatment and survival

    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 Outcomes (6)

  • 5 year disease free survival between short and long time to treatment

    5 years after treatment

  • 5 year disease specific survival between short and long time to treatment

    5 years after treatment

  • 5 year overall survival between short and long time to treatment

    5 years after treatment

  • 5 year disease free survival between participating centers

    5 years after treatment

  • 5 year disease specific survival between participating centers

    5 years after treatment

  • +1 more secondary outcomes

Study Arms (2)

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

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

Interventions

TreatmentOTHER

Patients were treated with surgery, radiotherapy or surgery with postoperative radiotherapy.

Long time to treatment (30 days or more)Short time to treatment (<30 days)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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

You may not qualify if:

  • Patients aged younger than 18 years
  • Patients with a T1 HNcSCC
  • Patients with recurrence or metastatic disease of a previously treated HNcSCC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Maastricht University Medical Center+

Maastricht, Netherlands

Location

Radboud University Medical Center

Nijmegen, Netherlands

Location

Related Publications (19)

  • Fania 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: 33572373BACKGROUND

  • Kallini 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: 25428226BACKGROUND

  • Que 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: 29332704BACKGROUND

  • Stern 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: 22264671BACKGROUND

  • Stratigos 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: 32113941BACKGROUND

  • Phung 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.

    PMID: 35866314BACKGROUND

  • Brantsch KD, Meisner C, Schonfisch B, Trilling B, Wehner-Caroli J, Rocken M, Breuninger H. Analysis of risk factors determining prognosis of cutaneous squamous-cell carcinoma: a prospective study. Lancet Oncol. 2008 Aug;9(8):713-20. doi: 10.1016/S1470-2045(08)70178-5. Epub 2008 Jul 9.

    PMID: 18617440BACKGROUND

  • Brougham ND, Dennett ER, Cameron R, Tan ST. The incidence of metastasis from cutaneous squamous cell carcinoma and the impact of its risk factors. J Surg Oncol. 2012 Dec;106(7):811-5. doi: 10.1002/jso.23155. Epub 2012 May 16.

    PMID: 22592943BACKGROUND

  • Mourouzis C, Boynton A, Grant J, Umar T, Wilson A, Macpheson D, Pratt C. Cutaneous head and neck SCCs and risk of nodal metastasis - UK experience. J Craniomaxillofac Surg. 2009 Dec;37(8):443-7. doi: 10.1016/j.jcms.2009.07.007. Epub 2009 Aug 27.

    PMID: 19713116BACKGROUND

  • Schmults CD, Karia PS, Carter JB, Han J, Qureshi AA. Factors predictive of recurrence and death from cutaneous squamous cell carcinoma: a 10-year, single-institution cohort study. JAMA Dermatol. 2013 May;149(5):541-7. doi: 10.1001/jamadermatol.2013.2139.

    PMID: 23677079BACKGROUND

  • Kyrgidis A, Tzellos TG, Kechagias N, Patrikidou A, Xirou P, Kitikidou K, Bourlidou E, Vahtsevanos K, Antoniades K. Cutaneous squamous cell carcinoma (SCC) of the head and neck: risk factors of overall and recurrence-free survival. Eur J Cancer. 2010 Jun;46(9):1563-72. doi: 10.1016/j.ejca.2010.02.046. Epub 2010 Mar 24.

    PMID: 20338745BACKGROUND

  • Peat B, Insull P, Ayers R. Risk stratification for metastasis from cutaneous squamous cell carcinoma of the head and neck. ANZ J Surg. 2012 Apr;82(4):230-3. doi: 10.1111/j.1445-2197.2011.05994.x. Epub 2012 Jan 31.

    PMID: 22510179BACKGROUND

  • Yung AE, Crouch G, Varey AHR, Lo S, Elliott MS, Lee J, Rawson R, Gupta R, Hong AM, Clark JR, Ch'ng S. Benchmarking Survival Outcomes Following Surgical Management of pT3 and pT4 Cutaneous Squamous Cell Carcinoma of the Head and Neck. Ann Surg Oncol. 2022 Aug;29(8):5124-5138. doi: 10.1245/s10434-022-11669-z. Epub 2022 Apr 13.

    PMID: 35419758BACKGROUND

  • van Hoeve JC, Vernooij RWM, Fiander M, Nieboer P, Siesling S, Rotter T. Effects of oncological care pathways in primary and secondary care on patient, professional and health systems outcomes: a systematic review and meta-analysis. Syst Rev. 2020 Oct 25;9(1):246. doi: 10.1186/s13643-020-01498-0.

    PMID: 33100227BACKGROUND

  • Schutte HW, van den Broek GB, Steens SCA, Hermens RPMG, Honings J, Marres HAM, Merkx MAW, Weijs WLJ, Arens AIJ, van Engen-van Grunsven ACH, van Herpen CML, Kaanders JHAM, van den Hoogen FJA, Takes RP. Impact of optimizing diagnostic workup and reducing the time to treatment in head and neck cancer. Cancer. 2020 Sep 1;126(17):3982-3990. doi: 10.1002/cncr.33037. Epub 2020 Jul 7.

    PMID: 32634271BACKGROUND

  • Rowe DE, Carroll RJ, Day CL Jr. Prognostic factors for local recurrence, metastasis, and survival rates in squamous cell carcinoma of the skin, ear, and lip. Implications for treatment modality selection. J Am Acad Dermatol. 1992 Jun;26(6):976-90. doi: 10.1016/0190-9622(92)70144-5.

    PMID: 1607418BACKGROUND

  • Endo Y, Tanioka M, Miyachi Y. Prognostic factors in cutaneous squamous cell carcinoma: is patient delay in hospital visit a predictor of survival? ISRN Dermatol. 2011;2011:285289. doi: 10.5402/2011/285289. Epub 2011 Nov 14.

    PMID: 22363846BACKGROUND

  • DeGraaff LH, Platek AJ, Iovoli AJ, Wooten KE, Arshad H, Gupta V, McSpadden RP, Kuriakose MA, Hicks WL Jr, Platek ME, Singh AK. The effect of time between diagnosis and initiation of treatment on outcomes in patients with head and neck squamous cell carcinoma. Oral Oncol. 2019 Sep;96:148-152. doi: 10.1016/j.oraloncology.2019.07.021. Epub 2019 Jul 30.

    PMID: 31422206BACKGROUND

  • Shang C, Feng L, Gu Y, Hong H, Hong L, Hou J. Impact of Multidisciplinary Team Management on the Survival Rate of Head and Neck Cancer Patients: A Cohort Study Meta-analysis. Front Oncol. 2021 Mar 8;11:630906. doi: 10.3389/fonc.2021.630906. eCollection 2021.

    PMID: 33763367BACKGROUND

Related Links

MeSH Terms

Conditions

Carcinoma, Squamous CellSkin NeoplasmsCarcinomaSquamous Cell Carcinoma of Head and NeckRecurrenceNeoplasm Metastasis

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesHead and Neck NeoplasmsDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplastic Processes

Study Officials

  • N Kelleners-Smeets, 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

April 17, 2023

First Posted

May 6, 2023

Study Start

January 1, 2022

Primary Completion

May 1, 2023

Study Completion

October 1, 2023

Last Updated

August 16, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

NL(2)