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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
| Aalborg University Hospital | OTHER |
| Vejle Hospital | OTHER |
| Rigshospitalet, Denmark |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Tumour Histology | Differences in risk of recurrence between basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) will be analyzed. | At least 2 years after completion of radiotherapy |
| Comparison between Short-Course and Long-Course Radiotherapy Regimens |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Treatment-Related Factors | Associations betweem outcomes and field size, field location | At least 2 years after completion of radiotherapy |
| Effect of Tumour Related Factors | Associations between outcomes and tumour related factors such as location and TNM stage . |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus N | 8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20393962 | Background | 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. | |
| 33202063 | 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. |
| Label | URL |
|---|---|
| Cancer Council Australia Keratinoyte Cancer Guidelines Working Party. Clinical Practice Guidelines for Keratinoyte Cancer. 25 Novembe | View source |
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Individual participant data will not be publicly available due to Danish data protection regulations. Aggregate results will be published in peer-reviewed journals.
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| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000359 | Aftercare |
| ID | Term |
|---|---|
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
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| OTHER |
| Copenhagen University Hospital at Herlev | OTHER |
| Danish Cancer Society | OTHER |
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Differences in risk of recurrence between the treatment regimens will be analyzed. |
| At least 2 years after completion of radiotherapy |
| Effect of Tumour Histology | Differences in cosmetic outcome between basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) will be analyzed | At least 2 years after completion of radiotherapy |
| Comparison between Short-Course and Long-Course Radiotherapy Regimens | Differences in cosmetic outcome between the treatment regimens will be analyzed. | At least 2 years after completion of radiotherapy. |
| At least 2 years after completion of radiotherapy |
| Effect of Patient-Related Factors | Associations between outcomes and patients factors such as age, sex, smoking status, performance status, previous NMSC | At least 2 years after completion of radiotherapy |
| Effect of Radiotherapy Modality | Associations on recurrence and cosmetic outcome depending on radiotherapy modality (kilovoltage (kV), electrons, photons) | At least 2 years after completion of primary radiotherapy for NMSC |
| 30242379 | 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. |
| 31831330 | 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. |
| 28843727 | 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. |
| 16310060 | 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. |
| 22818756 | 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. |
| 35833108 | 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. |
| 40442261 | Result | 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. |
| D018295 |
| Neoplasms, Basal Cell |
| D005159 |
| Health Care Facilities Workforce and Services |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |