{"entity":{"id":"mal-pdt-versus-surgery-nodular-bcc","kind":"trial","name":"Photodynamic therapy against surgery for nodular basal cell carcinoma","aka":["Rhodes trial","MAL-PDT versus excision surgery in nodular basal cell carcinoma"],"tldr":"For the thicker, lump-like basal cell carcinoma, light treatment clears about as many at three months as surgery does, but over five years three times as many come back. What it buys is a better-looking result, and that is the whole of the trade.","summary":"Photodynamic therapy was being used for nodular basal cell carcinoma without randomised evidence, so this trial was built to supply some. European university dermatology departments randomised 101 adults with previously untreated nodular basal cell carcinoma to methyl aminolevulinate photodynamic therapy, given twice a week apart with red light at 75 J per square centimetre, or to simple excision.\n\nThe short-term result flattered the light. Complete response at three months was 48 of 53 lesions (91 per cent) with photodynamic therapy against 51 of 52 (98 per cent), a difference of 4.8 percentage points (-3.4 to 13.0, p=0.25), and thirteen patients with an incomplete response were re-treated. Five years of follow-up settled it: recurrence occurred in 7 of 49 lesions (14 per cent, 95 per cent confidence interval 6 to 27) after photodynamic therapy against 2 of 52 (4 per cent, 1 to 13), p=0.09, and the estimated sustained complete response rate was 76 per cent (59 to 87) against 96 per cent (84 to 99), p=0.01.\n\nWhat photodynamic therapy bought was appearance, and the difference is large: 27 of 31 patients (87 per cent, 70 to 96) had an excellent or good cosmetic outcome after light against 19 of 35 (54 per cent, 37 to 71) after surgery, p=0.007. That is the honest shape of every non-surgical option in this disease. It is not a cure rate argument, it is a scar argument, and the person whose tumour is on the tip of the nose is entitled to weigh it.","status":"negative","asOf":"2026-09-25","links":[{"label":"One-year results (Archives of Dermatology 2004)","url":"https://doi.org/10.1001/archderm.140.1.17"},{"label":"Five-year follow-up (Archives of Dermatology 2007)","url":"https://doi.org/10.1001/archderm.143.9.1131"},{"label":"Five-year follow-up on PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/17875873/"},{"label":"Ten-year three-arm replication (Photodiagnosis and Photodynamic Therapy 2025)","url":"https://doi.org/10.1016/j.pdpdt.2025.104702"}],"tags":[],"related":[],"cancers":["basal-cell-carcinoma","skin-cancer"],"sections":[],"technologies":["photodynamic-therapy-lasers"],"targets":[],"drugs":["aminolevulinic-acid"],"companies":[],"institutions":[],"pathways":[],"terms":["topical-and-destructive-treatment-bcc"],"trials":["mal-pdt-imiquimod-fluorouracil-superficial-bcc","mal-pdt-versus-cryotherapy-superficial-bcc"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Previously untreated nodular basal cell carcinoma: methyl aminolevulinate photodynamic therapy given twice a week apart against simple excision surgery, with clinical clearance at three months as the primary endpoint and recurrence and cosmetic outcome to five years","sponsor":"Photocure and Galderma, run in European university dermatology departments","result":"Five-year recurrence 14 per cent after methyl aminolevulinate photodynamic therapy against 4 per cent after excision (sustained complete response 76 against 96 per cent, p=0.01), with an excellent or good cosmetic outcome in 87 against 54 per cent.","yearReported":2007,"enrolled":101,"enrolledBasis":"randomised","enrolledNote":"101 adults with previously untreated nodular basal cell carcinoma were randomised, 52 to photodynamic therapy and 49 to surgery; the trial ran before trial registration was required and has no registry record.","outcomes":[{"endpoint":"Lesion recurrence at 5 years","primary":true,"unit":"%","arms":[{"name":"Methyl aminolevulinate photodynamic therapy","n":49,"value":14,"note":"7 of 49 lesions; 95 per cent confidence interval 6 to 27"},{"name":"Excision surgery","n":52,"value":4,"note":"2 of 52 lesions; 95 per cent confidence interval 1 to 13"}],"p":"0.09","source":"https://doi.org/10.1001/archderm.143.9.1131"},{"endpoint":"Sustained lesion complete response at 5 years","unit":"%","arms":[{"name":"Methyl aminolevulinate photodynamic therapy","value":76,"note":"95 per cent confidence interval 59 to 87"},{"name":"Excision surgery","value":96,"note":"95 per cent confidence interval 84 to 99"}],"p":"0.01","source":"https://doi.org/10.1001/archderm.143.9.1131"},{"endpoint":"Excellent or good cosmetic outcome at 5 years","unit":"%","arms":[{"name":"Methyl aminolevulinate photodynamic therapy","n":31,"value":87,"note":"27 of 31 patients; 95 per cent confidence interval 70 to 96"},{"name":"Excision surgery","n":35,"value":54,"note":"19 of 35 patients; 95 per cent confidence interval 37 to 71"}],"p":"0.007","source":"https://doi.org/10.1001/archderm.143.9.1131"}],"replication":"A Brazilian three-arm randomised trial of 567 small nodular basal cell carcinomas with ten years of follow-up found the same ordering: recurrence-free survival at ten years of 92.8 per cent after surgery, 74.5 per cent after aminolevulinic acid photodynamic therapy and 69 per cent after methyl aminolevulinate photodynamic therapy."},"route":"/trials/mal-pdt-versus-surgery-nodular-bcc/","neighbours":{"cancer":[{"id":"basal-cell-carcinoma","kind":"cancer","name":"Basal cell carcinoma","route":"/cancers/basal-cell-carcinoma/"},{"id":"skin-cancer","kind":"cancer","name":"Skin cancer (all types)","route":"/cancers/skin-cancer/"}],"technology":[{"id":"photodynamic-therapy-lasers","kind":"technology","name":"Photodynamic therapy lasers and light sources","route":"/technologies/photodynamic-therapy-lasers/"}],"drug":[{"id":"aminolevulinic-acid","kind":"drug","name":"Aminolevulinic acid (topical, for photodynamic therapy)","route":"/drugs/aminolevulinic-acid/"}],"term":[{"id":"topical-and-destructive-treatment-bcc","kind":"term","name":"Creams, light and cold for basal cell carcinoma","route":"/terms/topical-and-destructive-treatment-bcc/"}],"trial":[{"id":"mal-pdt-versus-cryotherapy-superficial-bcc","kind":"trial","name":"Photodynamic therapy against cryotherapy for superficial basal cell carcinoma","route":"/trials/mal-pdt-versus-cryotherapy-superficial-bcc/"},{"id":"mal-pdt-imiquimod-fluorouracil-superficial-bcc","kind":"trial","name":"Photodynamic therapy against imiquimod against fluorouracil for superficial basal cell carcinoma","route":"/trials/mal-pdt-imiquimod-fluorouracil-superficial-bcc/"}]}}