{"entity":{"id":"mohs-versus-excision-facial-bcc","kind":"trial","name":"Mohs surgery against ordinary excision for facial basal cell carcinoma (Nijmegen trial)","aka":["Nijmegen Mohs trial","Mohs versus surgical excision trial","Dutch Mohs trial"],"tldr":"This is the only randomised trial of the microscope-guided skin cancer operation against the ordinary one. For a cancer that has already come back once, the microscope-guided operation clearly wins. For a cancer being treated the first time, the difference took ten years to appear and never reached statistical significance.","summary":"Seven hospitals in the Netherlands randomised 408 primary and 204 recurrent high-risk facial basal cell carcinomas to Mohs micrographic surgery or to ordinary excision between October 1999 and February 2002. High risk meant a diameter of at least 1 cm, a location in the H-zone of the face, or an aggressive histological subtype. The two groups were randomised separately and are reported separately, which is the point of the trial: the question was not whether Mohs surgery works but in which tumours it is worth its cost.\n\nAt five years the difference in primary tumours was small and not significant: seven recurrences (4.1 per cent) after ordinary excision against four (2.5 per cent) after Mohs surgery, log-rank p=0.397. In recurrent tumours it was significant: ten recurrences (12.1 per cent) after ordinary excision against two (2.4 per cent) after Mohs surgery, p=0.015. Treatment cost 1,248 euros for Mohs surgery against 990 euros for excision in primary tumours and 1,284 against 1,043 euros in recurrent tumours, giving an incremental cost-effectiveness ratio of 23,454 euros for primary and 3,171 euros for recurrent disease. The trial's own conclusion at that point was that ordinary excision is probably enough for most primary tumours.\n\nThe ten-year report changed the shape of the answer without changing its statistics. Cumulative ten-year recurrence was 4.4 per cent after Mohs surgery against 12.2 per cent after excision for primary tumours (log-rank p=0.100) and 3.9 against 13.5 per cent for recurrent tumours (p=0.023). The number that matters most for the reader is this: 56 per cent of the recurrences in primary tumours happened more than five years after treatment, and 14 per cent of those in recurrent tumours. Any five-year trial in this disease, including this one, is reading half the story.","status":"positive","asOf":"2026-09-25","links":[{"label":"ISRCTN65009900","url":"https://www.isrctn.com/ISRCTN65009900"},{"label":"Five-year results (Lancet Oncology 2008)","url":"https://doi.org/10.1016/S1470-2045(08)70260-2"},{"label":"Ten-year results (European Journal of Cancer 2014)","url":"https://doi.org/10.1016/j.ejca.2014.08.018"},{"label":"Ten-year results on PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/25262378/"}],"tags":[],"related":[],"cancers":["basal-cell-carcinoma","skin-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["mohs-surgery","surgical-margins-keratinocyte-cancer","resection-margins"],"trials":["sins-trial","avril-surgery-versus-radiotherapy-bcc"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN65009900","phase":"3","setting":"High-risk facial basal cell carcinoma, defined as at least 1 cm across, in the central face, or of an aggressive histological subtype, and separately facial basal cell carcinoma that had already recurred: Mohs micrographic surgery against ordinary surgical excision, with recurrence of the carcinoma as the primary outcome and ten years of follow-up","sponsor":"Radboud University Nijmegen Medical Centre, the Netherlands","result":"Ten-year cumulative recurrence 4.4 per cent after Mohs surgery against 12.2 per cent after ordinary excision for primary high-risk facial basal cell carcinoma (p=0.100), and 3.9 against 13.5 per cent for recurrent tumours (p=0.023); 56 per cent of primary-tumour recurrences occurred after year five.","yearReported":2014,"enrolled":612,"enrolledBasis":"randomised","enrolledNote":"408 primary and 204 recurrent facial basal cell carcinomas were randomised between October 1999 and February 2002, 612 tumours in 565 patients; the ISRCTN record carries no enrolment figure and the two tumour groups were randomised and analysed separately.","outcomes":[{"endpoint":"Cumulative recurrence at 10 years, primary facial basal cell carcinoma","primary":true,"unit":"%","arms":[{"name":"Mohs micrographic surgery","value":4.4},{"name":"Ordinary surgical excision","value":12.2}],"p":"0.100","source":"https://doi.org/10.1016/j.ejca.2014.08.018"},{"endpoint":"Cumulative recurrence at 10 years, recurrent facial basal cell carcinoma","primary":true,"unit":"%","arms":[{"name":"Mohs micrographic surgery","value":3.9},{"name":"Ordinary surgical excision","value":13.5}],"p":"0.023","source":"https://doi.org/10.1016/j.ejca.2014.08.018"},{"endpoint":"Recurrence at 5 years, primary facial basal cell carcinoma","unit":"%","arms":[{"name":"Mohs micrographic surgery","value":2.5,"note":"4 of the tumours followed up"},{"name":"Ordinary surgical excision","value":4.1,"note":"7 of the tumours followed up"}],"p":"0.397","source":"https://doi.org/10.1016/s1470-2045(08)70260-2"},{"endpoint":"Recurrence at 5 years, recurrent facial basal cell carcinoma","unit":"%","arms":[{"name":"Mohs micrographic surgery","value":2.4,"note":"2 of the tumours followed up"},{"name":"Ordinary surgical excision","value":12.1,"note":"10 of the tumours followed up"}],"p":"0.015","source":"https://doi.org/10.1016/s1470-2045(08)70260-2"},{"endpoint":"Treatment cost, primary facial basal cell carcinoma","unit":"euros","arms":[{"name":"Mohs micrographic surgery","value":1248,"note":"incremental cost-effectiveness ratio 23,454 euros per recurrence avoided"},{"name":"Ordinary surgical excision","value":990}],"source":"https://doi.org/10.1016/s1470-2045(08)70260-2"}],"replication":"No second randomised trial of Mohs surgery against ordinary excision exists in basal cell carcinoma. Everything else in the field is a single-arm series, which is why the American appropriate use criteria rest on consensus rather than on randomised evidence."},"route":"/trials/mohs-versus-excision-facial-bcc/","neighbours":{"cancer":[{"id":"basal-cell-carcinoma","kind":"cancer","name":"Basal cell carcinoma","route":"/cancers/basal-cell-carcinoma/"},{"id":"cutaneous-scc","kind":"cancer","name":"Cutaneous squamous cell carcinoma","route":"/cancers/cutaneous-scc/"},{"id":"skin-cancer","kind":"cancer","name":"Skin cancer (all types)","route":"/cancers/skin-cancer/"}],"term":[{"id":"mohs-surgery","kind":"term","name":"Mohs surgery","route":"/terms/mohs-surgery/"},{"id":"resection-margins","kind":"term","name":"Resection margins (R0 / R1 / R2)","route":"/terms/resection-margins/"},{"id":"surgical-margins-keratinocyte-cancer","kind":"term","name":"The margin in skin cancer surgery","route":"/terms/surgical-margins-keratinocyte-cancer/"}],"trial":[{"id":"sins-trial","kind":"trial","name":"SINS (surgical excision against imiquimod cream for basal cell carcinoma)","route":"/trials/sins-trial/"},{"id":"avril-surgery-versus-radiotherapy-bcc","kind":"trial","name":"Surgery against radiotherapy for basal cell carcinoma of the face","route":"/trials/avril-surgery-versus-radiotherapy-bcc/"}]}}