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

NCT07347392 | Enrolling By Invitation

• 1 other identifier: DOSCA-2-AUH
• Study Type: observational
• Target: 2,900
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Cosmetic outcome

  The primary outcome is cosmetic outcome, assessed by both the patient and a health professional using the LENT-SOMA criteria.

  At least 2 years after completion of primary radiotherapy for NMSC

• Local recurrence

  Identified through the Danish Pathology Registry and follow-up visit

  At least 2 years after completion of primary radiotherapy for NMSC

Secondary Outcomes (4)

• Effect of Tumour Histology

  At least 2 years after completion of radiotherapy

• Comparison between Short-Course and Long-Course Radiotherapy Regimens

  At least 2 years after completion of radiotherapy

• Effect of Tumour Histology

  At least 2 years after completion of radiotherapy

• Comparison between Short-Course and Long-Course Radiotherapy Regimens

  At least 2 years after completion of radiotherapy.

Other Outcomes (4)

• Effect of Treatment-Related Factors

  At least 2 years after completion of radiotherapy

• Effect of Tumour Related Factors

  At least 2 years after completion of radiotherapy

• Effect of Patient-Related Factors

  At least 2 years after completion of radiotherapy

Interventions

Follow-up visit at least two years after treatment OTHER

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.

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

Adults aged 18 years or older with head and neck non-melanoma skin cancer (basal cell carcinoma or cutaneous squamous cell carcinoma) who received primary radiotherapy between 2020 and 2024 at five Danish oncology centres. Participants will be invited via the national digital mailbox (e-Boks) to attend a hospital follow-up visit at the centre where they received radiotherapy, at least two years after completion of treatment. The study represents a real-world national cohort within the Danish public health-care system.

You may qualify if:

• 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

You may not qualify if:

• Individuals who are incapable of giving informed consent

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator
• Aalborg University Hospital: collaborator
• Vejle Hospital: collaborator
• Rigshospitalet, Denmark: collaborator
• Copenhagen University Hospital at Herlev: collaborator
• Danish Cancer Society: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

Related Publications (9)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 2019 Dec 9.

  PMID: 31831330 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Braendstrup ON, Lassen P, Gothelf AB, De Blanck SR, Friborg J, Lonkvist CK, Nielsen AL, Primdahl H, Hanan G, Toure M, Andersen M, Nowicka-Matus K, Kjeldsen R, Eriksen JG. Initial cosmetic outcome six months after kilovoltage therapy of facial basal cell carcinoma: A Danish national prospective study of 932 patients. Sci Rep. 2025 May 29;15(1):18790. doi: 10.1038/s41598-025-03566-8.

  PMID: 40442261 RESULT

Related Links

• Cancer Council Australia Keratinoyte Cancer Guidelines Working Party. Clinical Practice Guidelines for Keratinoyte Cancer. 25 Novembe

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Aftercare

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Jesper Grau Eriksen, Professor MD PhD

  Department of Experimential Clinical Oncology, Aarhus University Hospital, Denmark

  STUDY CHAIR

• Anita Gothelf, MD PhD

  Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

• Pernille Lassen, MD PhD

  Department of Oncology, Copenhagen University Hospital, Herlev, Denmark

  PRINCIPAL INVESTIGATOR

• Rasmus Kjeldsen, MD

  Department of Oncology, Aalborg University Hospital, Denmark

  PRINCIPAL INVESTIGATOR

• Gulalai Hanan, MD

  Department of Oncology, Vejle Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: January 16, 2026
• Study Start: December 15, 2025
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: January 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)