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Enrolling by invitation NCT07347392

The Role of Radiotherapy for the Management of Non-melanoma Skin Cancer in Denmark.

— Observational Non-Melanoma Skin Cancer (NMSC) Basal Cell Carcinoma of Skin Squamous Cell Carcinoma of the Skin

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Follow-up visit at least two years after treatment.
Who it may be relevant to
Registry conditions: Non-Melanoma Skin Cancer (NMSC), Basal Cell Carcinoma of Skin, Squamous Cell Carcinoma of the Skin. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Role of Radiotherapy for the Management of Non-melanoma Skin Cancer in Denmark

Overview

The goal of this observational study is to learn about the long-term effects of radiotherapy for people who were treated for non-melanoma skin cancer (NMSC) in the head and neck area. The study focuses on adults who finished radiotherapy at least two years ago. The main questions we aim to answer are: How satisfied are participants with the cosmetic result of their treatment? What skin changes do healthcare professionals observe at the treated area? How many participants have experienced a recurrence or developed a new skin cancer, since treatment? Participants will be invited to: Attend one extra hospital visit at least two years after they finished radiotherapy Answer a short questionnaire about their cosmetic satisfaction Have their skin examined, including photos and dermatoscopy The results may help improve future treatment guidelines for people with non-melanoma skin cancer.professional, and any local recurrences will be identified through national health registries. This nationwide study (DOSCA-2) will provide real-world data to help guide future treatment recommendations for NMSC.

Interventions

  • Other Follow-up visit at least two years after treatment
    In Denmark, people treated with primary radiotherapy for NMSC are not routinely offered a hospital follow-up visit to evaluate cosmetic results or recurrence. In this study, patients who received radiotherapy between 2020 and 2024 at five Danish cancer centers will be invited for a clinical examination at least two years after treatment. Cosmetic outcome will be rated by both the patient and a health professional, and any local recurrences will be identified through national health registries.

Primary outcome measures

  • Cosmetic outcome [Time frame: At least 2 years after completion of primary radiotherapy for NMSC]
  • Local recurrence [Time frame: At least 2 years after completion of primary radiotherapy for NMSC]
Secondary outcome measures (4)
  • Effect of Tumour Histology [Time frame: At least 2 years after completion of radiotherapy]
  • Comparison between Short-Course and Long-Course Radiotherapy Regimens [Time frame: At least 2 years after completion of radiotherapy]
  • Effect of Tumour Histology [Time frame: At least 2 years after completion of radiotherapy]
  • Comparison between Short-Course and Long-Course Radiotherapy Regimens [Time frame: At least 2 years after completion of radiotherapy.]

Eligibility criteria

Inclusion criteria

  • Adults aged 18 years or older
  • Received primary radiotherapy for malignant non-melanoma skin cancer (basal cell carcinoma or cutaneous squamous cell carcinoma) of the head and neck region between 2020 and 2024
  • Able to understand and communicate in written and spoken Danish or English

Exclusion criteria

  • Individuals who are incapable of giving informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Denmark · 1 center
  • Aarhus University Hospital — Aarhus N

Publications

  • Lansbury L, Leonardi-Bee J, Perkins W, Goodacre T, Tweed JA, Bath-Hextall FJ. Interventions for non-metastatic squamous cell carcinoma of the skin. Cochrane Database Syst Rev. 2010 Apr 14;2010(4):CD007869. doi: 10.1002/14651858.CD007869.pub2. PMID 20393962
  • Thomson J, Hogan S, Leonardi-Bee J, Williams HC, Bath-Hextall FJ. Interventions for basal cell carcinoma of the skin. Cochrane Database Syst Rev. 2020 Nov 17;11(11):CD003412. doi: 10.1002/14651858.CD003412.pub3. PMID 33202063
  • Drucker AM, Adam GP, Rofeberg V, Gazula A, Smith B, Moustafa F, Weinstock MA, Trikalinos TA. Treatments of Primary Basal Cell Carcinoma of the Skin: A Systematic Review and Network Meta-analysis. Ann Intern Med. 2018 Oct 2;169(7):456-466. doi: 10.7326/M18-0678. Epub 2018 Sep 18. PMID 30242379
  • Likhacheva A, Awan M, Barker CA, Bhatnagar A, Bradfield L, Brady MS, Buzurovic I, Geiger JL, Parvathaneni U, Zaky S, Devlin PM. Definitive and Postoperative Radiation Therapy for Basal and Squamous Cell Cancers of the Skin: Executive Summary of an American Society for Radiation Oncology Clinical Practice Guideline. Pract Radiat Oncol. 2020 Jan-Feb;10(1):8-20. doi: 10.1016/j.prro.2019.10.014. Epub PMID 31831330
  • Zaorsky NG, Lee CT, Zhang E, Keith SW, Galloway TJ. Hypofractionated radiation therapy for basal and squamous cell skin cancer: A meta-analysis. Radiother Oncol. 2017 Oct;125(1):13-20. doi: 10.1016/j.radonc.2017.08.011. Epub 2017 Aug 23. PMID 28843727
  • Schulte KW, Lippold A, Auras C, Bramkamp G, Breitkopf C, Elsmann HJ, Habenicht EM, Jasnoch V, Muller-Pannes H, Rupprecht R, Suter L. Soft x-ray therapy for cutaneous basal cell and squamous cell carcinomas. J Am Acad Dermatol. 2005 Dec;53(6):993-1001. doi: 10.1016/j.jaad.2005.07.045. PMID 16310060
  • Cognetta AB, Howard BM, Heaton HP, Stoddard ER, Hong HG, Green WH. Superficial x-ray in the treatment of basal and squamous cell carcinomas: a viable option in select patients. J Am Acad Dermatol. 2012 Dec;67(6):1235-41. doi: 10.1016/j.jaad.2012.06.001. Epub 2012 Jul 19. PMID 22818756
  • Benkhaled S, Van Gestel D, Gomes da Silveira Cauduro C, Palumbo S, Del Marmol V, Desmet A. The State of the Art of Radiotherapy for Non-melanoma Skin Cancer: A Review of the Literature. Front Med (Lausanne). 2022 Jun 27;9:913269. doi: 10.3389/fmed.2022.913269. eCollection 2022. PMID 35833108

Identifiers

NCT: NCT07347392 · DOSCA-2-AUH

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗