[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Marieke Goodijk\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":44},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100633761","phase-3-no-re-excision-melanoma---norma-2-100633761",false,"NCT07530887","NO Re-excision MelanomA - NORMA 2","Multicenter Phase 3 Randomized Controlled Trial of NO Re-excision MelanomA - NORMA 2","NORMA-2","Inclusion Criteria:\n\n* Patients must be 18 years or older at time of consent\n* Patients must have an ECOG performance score between 0 and 2\n* Histologically confirmed, stage pT1b - pT4b (TNM AJCC 8th edition) cutaneous primary melanoma\n* Histological subtypes that are eligible are:\n\n  * Superficial Spreading Melanoma (SSM)\n  * Nodular Melanoma (NM)\n* The primary melanoma must have been removed by diagnostic excision and must have at least a minimum of 1 mm tumor free margin for invasive melanoma AND any in situ melanoma\n* Patient must provide informed consent and comply with the treatment protocol and follow-up plan\n* Life expectancy of at least 5 years from the time of diagnosis, not considering the melanoma in question, as determined by the investigator\n* A survivor of prior cancer is eligible provided that ALL of the following criteria are met and documented:\n\n  * The patient has undergone potentially curative therapy for all prior malignancies\n  * Life expectancy should be at least 5 years and\n  * The patient is deemed by their treating physician to be at low risk of recurrence from previous malignancies.\n\nExclusion Criteria:\n\n* Non-cutaneous melanoma (uveal, mucosal)\n* Acral melanoma\n* Lentigo malignant melanoma (LMM)\n* Desmoplastic melanoma\n* Neurotropic melanoma\n* Spitz melanoma\u002Fmalignant Spitz tumor melanoma\n* Satellites, in-transit melanomas or macroscopic melanoma metastases\n* Uncertain diagnosis of melanoma i.e. so-called 'melanocytic lesions of unknown malignant potential' (MELTUMP or STUMP)\n* Other non-SSM or NM subtypes\n* Melanoma removed by shave excision, excogliation or core biopsy\n* Patient has already undergone a local flap reconstruction of the defect after excision of the primary\n* History of previous or concurrent (i.e., second primary) invasive melanoma\n* Multiple melanomas\n* Patient has undergone surgery on a separate occasion to clear the lymph nodes of the probable draining lymphatic field, except for previous SLNB\n* Any additional solid tumor or hematologic malignancy during the past 5 years with a life expectancy of less than 5 years\n* History of organ transplantation","ALL",{"count":19,"type":20},1749,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This multicenter, phase III randomized controlled trial evaluates whether omitting re-excision after complete primary excision of cutaneous melanoma affects patient outcomes. A total of 1,749 patients with pT1b-pT4b cutaneous melanoma without evidence of metastases will be randomized to either standard re-excision according to current guidelines or no re-excision. Sentinel lymph node biopsy and adjuvant systemic therapy will be performed as indicated in both groups.\n\nThe primary objective is to compare relapse-free survival (RFS) between the two groups. Secondary objectives include comparisons of overall survival (OS), local recurrence rates, recurrence of in-transit and lymph node metastases, distant metastasis-free survival (DMFS), surgical morbidity, quality of life, and health economic outcomes.",[26],"Melanoma (Skin Cancer)",[28,29,30],"primary cutaneous melanoma","re-excision","de-escalation","RECRUITING","2026-04-08",{"date":34,"type":35},"2026-04-15","ACTUAL",{"date":37,"type":35},"2025-11-13",{"date":39,"type":20},"2033-11",{"name":41,"class":42},"Marieke Goodijk","OTHER",21,""]