Trial of Surgical Excision Margins in Thick Primary Melanoma
|ClinicalTrials.gov Identifier: NCT01183936|
Recruitment Status : Completed
First Posted : August 18, 2010
Last Update Posted : August 18, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma Surgery Treatment Outcome||Procedure: 2-cm margin Procedure: 4-cm margin||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||936 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 1992|
|Actual Primary Completion Date :||May 2004|
|Actual Study Completion Date :||December 2006|
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.
- Overall survival
- Recurrence free survival
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01183936
|Study Director:||Ulrik Ringborg, M.D., Ph.D.||Dept of Oncology-Pathology, Karolinska Institute|