Condition: Melanoma (Skin Cancer) · Sponsor: Marieke Goodijk
Interested? Contact the study team ↓
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. The 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.
This description comes directly from the study's public registry record.
Y. (Yvonne) M. Schrage, MD PhD · 020 512 9111 · y.schrage@nki.nl
M. (Marieke) T. Goodijk, MD PhD Candidate · 020 512 2546 · m.goodijk@nki.nl
There is no obligation to join — the study team can answer your questions about taking part.
Always discuss trial participation with your own doctor first.
Inclusion Criteria: * Patients must be 18 years or older at time of consent * Patients must have an ECOG performance score between 0 and 2 * Histologically confirmed, stage pT1b - pT4b (TNM AJCC 8th edition) cutaneous primary melanoma * Histological subtypes that are eligible are: * Superficial Spreading Melanoma (SSM) * Nodular Melanoma (NM) * 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 * Patient must provide informed consent and comply with the treatment protocol and follow-up plan * Life expectancy of at least 5 years from the time of diagnosis, not considering the melanoma in question, as determined by the investigator * A survivor of prior cancer is eligible provided that ALL of the following criteria are met and documented: * The patient has undergone potentially curative therapy for all prior malignancies * Life expectancy should be at least 5 years and * The patient is deemed by their treating physician to be at low risk of recurrence from previous malignancies. Exclusion Criteria: * Non-cutaneous melanoma (uveal, mucosal) * Acral melanoma * Lentigo malignant melanoma (LMM) * Desmoplastic melanoma * Neurotropic melanoma * Spitz melanoma/malignant Spitz tumor melanoma * Satellites, in-transit melanomas or macroscopic melanoma metastases * Uncertain diagnosis of melanoma i.e. so-called 'melanocytic lesions of unknown malignant potential' (MELTUMP or STUMP) * Other non-SSM or NM subtypes * Melanoma removed by shave excision, excogliation or core biopsy * Patient has already undergone a local flap reconstruction of the defect after excision of the primary * History of previous or concurrent (i.e., second primary) invasive melanoma * Multiple melanomas * Patient has undergone surgery on a separate occasion to clear the lymph nodes of the probable draining lymphatic field, except for previous SLNB * Any additional solid tumor or hematologic malignancy during the past 5 years with a life expectancy of less than 5 years * History of organ transplantation
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Jeroen Bosch Ziekenhuis | 's-Hertogenbosch, Netherlands | Recruiting |
| Noordwest Ziekenhuisgroep | Alkmaar, Netherlands | Recruiting |
| Flevoziekenhuis | Almere Stad, Netherlands | Recruiting |
| Antoni van Leeuwenhoek | Amsterdam, Netherlands | Recruiting |
| Gelre ziekenhuizen | Apeldoorn, Netherlands | Recruiting |
| Rijnstate Ziekenhuis | Arnhem, Netherlands | Recruiting |
| Catharina ziekenhuis | Eindhoven, Netherlands | Not Yet Recruiting |
| Medisch Spectrum Twente | Enschede, Netherlands | Recruiting |
| Groene Hart Ziekenhuis | Gouda, Netherlands | Not Yet Recruiting |
| Martini ziekenhuis | Groningen, Netherlands | Not Yet Recruiting |
| Tergooi MC | Hilversum, Netherlands | Not Yet Recruiting |
| Dijklander Ziekenhuis | Hoorn, Netherlands | Not Yet Recruiting |
+ 9 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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