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Trial of Surgical Excision Margins in Thick Primary Melanoma

NCT01183936 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 936

Last updated 2010-08-18

No results posted yet for this study

Summary

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.

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

  • Swedish Cancer Society

    collaborator OTHER

  • Stockholm Cancer Society

    collaborator UNKNOWN

  • Karolinska Institutet

    lead OTHER

Principal Investigators

  • Ulrik Ringborg, M.D., Ph.D. · Dept of Oncology-Pathology, Karolinska Institute

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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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 NCT01183936 on ClinicalTrials.gov