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Trial of Surgical Excision Margins in Thick Primary Melanoma - 2

NCT03638492 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 936

Last updated 2018-08-20

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Peter Gillgren

    lead OTHER

Principal Investigators

  • Ulrik Ringborg, M.D., Ph.d. · Karolinska inteitutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1992-01-31
Primary Completion
2004-05-31
Completion
2006-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03638492 on ClinicalTrials.gov