Melanoma Skin cancer
Conditions
Interventions
The omission of re-excision after complete primary excision of a pT1a melanoma.
Sponsors
Haaglanden Medisch Centrum (HMC)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Adult (=18 years of age at the time of consent).Ability to understand the study information and provide written informed consent. This requires that the patient is able to read and comprehend written Dutch to understand the Patient Information Folder (PIF) and sign the Informed Consent Form (ICF).Diagnosed with a histopathologically confirmed primary excised pT1a melanoma (Breslow thickness <0.8 mm without ulceration, AJCC 8th). The pathology report must provide a definitive conclusion, leaving no doubt about the melanoma diagnosis.A histopathologically examined diagnostic excision margin of =1 mm and =5 mm (narrowest margin).Ability to participate in and complete the 5-year follow-up, as determined by the treating physician. Willingness to complete questionnaires at several time points (preferably sent by e-mail or otherwise on paper).
Exclusion criteria
Exclusion criteria: Stage IB, II, III, or IV melanoma.Clinically or radiologically detectable nodal disease, (micro-)satellites, in-transit metastases and/or distant organ metastases. Melanoma removed through core biopsy, shave excision or curettage. Re-excision at the site of the index lesion already performed before informed consent.Non-cutaneous (uveal or mucosal) melanoma.Acral melanoma.Melanoma in situ.Lentigo maligna melanoma.Desmoplastic melanoma.Neurotropic melanoma.Spitz melanoma/ malignant Spitz tumor melanoma.Melanocytic tumor of uncertain malignant potential, including Spitz Melanocytic Tumor of Uncertain Malignant Potential (SAMPUS), Melanocytic Tumor of Uncertain Malignant Potential (MELTUMP) and Spitzoid Tumor of Uncertain Malignant Potential (STUMP).History of previous invasive melanoma.Synchronous (i.e., second primary) melanoma or multiple melanomas (simultaneous melanomas diagnosed at different anatomical sites).More than 12 weeks between diagnostic excision and (planned) re-excision.More than 8 weeks between diagnostic excision and informed consent.Previous or intercurrent malignancy, except: curatively treated malignancy =5 years ago;cutaneous squamous cell carcinoma or basal cell carcinoma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is the locoregional recurrence rate during 5 years of follow-up in the experimental arm. | — |
Secondary
| Measure | Time frame |
|---|---|
| Other outcomes include overall survival (OS), melanoma-specific survival (MSS), recurrence-free survival (RFS), health related quality of life (HRQoL), cost-effectiveness, complication rates and the need for oncoplastic reconstruction in the group undergoing re-excision, the 5-year LRR after re-excision, reasons for treatment choice, and the association between patient characteristics and treatment choice. | — |
Countries
Netherlands
Contacts
Public ContactM.E. Straver
Haaglanden Medisch Centrum (HMC)
Outcome results
None listed