Trial of Surgical Excision Margins in Thick Primary Melanoma - 2
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|ClinicalTrials.gov Identifier: NCT03638492|
Recruitment Status : Completed
First Posted : August 20, 2018
Last Update Posted : August 20, 2018
Objectives: The purpose of this study was to assess the long-term follow-up of the overall and melanoma-specific survival in the randomised, open-lable multicenter trial (NTC NCT01183936) comparing excision margin of 2 cm versus 4 cm for patients with primary cutaneous malignant melanoma (CMM) thicker than 2 mm.
Study hypothesis: The hypothesis is that there is no difference between the two treatment arms measured as melanoma-specific survival and overall survival.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma Surgery Treatment Outcome||Procedure: 2-cm margin Procedure: 4-cm margin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||936 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Long-term Follow-up of Survival in Surgical Resected Invasive Cutaneous Melanomas: Comparing 2-cm Versus 4 -cm Resection Margins - a Randomized, Multicenter Trial|
|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.
- Melanoma-specific survival [ Time Frame: 24.9 years ]Cause of death: cutaneous malignant melanoma
- Overall survival [ Time Frame: 24.9 years ]Cause of death: all death causes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03638492
|Principal Investigator:||Ulrik Ringborg, M.D., Ph.d.||Karolinska inteitutet|