Trial of Surgical Excision Margins in Thick Primary Melanoma
Objectives: The purpose of this study was to assess the effects of an excision margin of 2 cm versus 4 cm for patients with primary cutaneous malignant melanoma (CMM).
Study hypothesis: The hypothesis is that there is no difference between the two treatment arms measured as overall survival and recurrence free survival.
|Melanoma Surgery Treatment Outcome||Procedure: 2-cm margin Procedure: 4-cm margin|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomised Trial of Surgical Excision Margins for Thick Primary Cutaneous Melanoma (>2 mm). A Multicenter Trial Comparing 2-cm vs 4-cm|
- Overall survival
- Recurrence free survival
|Study Start Date:||January 1992|
|Study Completion Date:||December 2006|
|Primary Completion Date:||May 2004 (Final data collection date for primary outcome measure)|
Active Comparator: 2 cm margin of excision
Patients with CMM >2 mm treated with an excision of 2-cm.
Procedure: 2-cm margin
Patients with CMM treated with a surgical safety margin of 2-cm in the surrounding skin and down to the fascia.
Active Comparator: 4 cm margin of excision
Patients with CMM >2 mm treated with an excision of 4-cm.
Procedure: 4-cm margin
Patients with CMM treated with a surgical safety margin of 4-cm in the surrounding skin and down to the fascia.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01183936
|Study Director:||Ulrik Ringborg, M.D., Ph.D.||Dept of Oncology-Pathology, Karolinska Institute|