RecruitingNot ApplicableNCT06363591

WoW - Single- vs Two-staged Excisions of Thin Melanoma

Wise vs Wide: A National, Multicenter, Prospective, Randomized and Controlled, Parallel Group, Non-inferiority Study to Compare Single- vs Two-staged Excisions of Thin Melanoma

Sponsor

Vastra Gotaland Region

Enrollment

2,486 participants

Start Date

Jan 22, 2025

Study Type

INTERVENTIONAL

Conditions

Melanoma

Summary

The overall aim of this national, multicenter, prospective, randomized, and controlled study is to enhance the management of patients with thin melanoma (≤1 mm Breslow thickness). The investigators hypothesize that wide local excisions (WLEs) following complete excision of thin melanoma do not affect the risk of recurrence, defined as the occurrence of local, regional, distant disease, or melanoma-specific death during a 5- to 10-year follow-up period.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

Patients need to fulfill all criteria listed below:
Has recently been diagnosed with a primary invasive cutaneous melanoma of Breslow thickness ≤1.0 mm (pT1) as determined by a diagnostic excision with subsequent histopathological analysis that:
Is located on a body location in which a WLE with a 10-mm clinical margin is feasible and would have been planned according to current standard of care.
Had histopathologically verified free margins of at least 1.5 mm.
Is 18 years or older at time of consent.
Is able to give informed consent and comply with the treatment protocol and follow-up plan.
Has a life expectancy of ≥5 years from the time of diagnosis.

Exclusion Criteria11

If any of the listed criteria below are present, the patient is ineligible for study participation.
The study lesion:
was partially biopsied prior to the diagnostic excision.
was diagnostically excised with a clinical margin \>5 mm.
was a melanoma of desmoplastic or lentiginous (i.e. lentigo maligna or acral lentiginous) subtype.
was located on digits in which amputation is necessary.
The patient:
had a previous or concurrent MIS or invasive melanoma (cutaneous or non-cutaneous).
had physical, clinical, radiographic or pathologic evidence of microsatellite, satellite, in-transit, regional or distant metastatic melanoma.
had a previous or intercurrent treated solid tumor or hematologic malignancy during the past 5 years except cutaneous squamous cell carcinoma or basal cell carcinoma.
has planned adjuvant radiotherapy to the primary melanoma site after WLE.