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Trial of Surgical Excision Margins in Thick Primary Melanoma

This study has been completed.
Sponsor:
Collaborators:
Swedish Cancer Society
Stockholm Cancer Society
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01183936
First received: August 17, 2010
Last updated: NA
Last verified: June 1991
History: No changes posted
  Purpose

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 Intervention
Melanoma
Surgery
Treatment Outcome
 Procedure: 2-cm margin
Procedure: 4-cm margin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Overall survival

Secondary Outcome Measures:
  • Recurrence free survival

Enrollment: 936
Study Start Date: January 1992
Study Completion Date: December 2006
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Melanoma >2 mm
  • Age ≤ 75 yr
  • Patients operated on with ≤ 2-cm at diagnosis
  • Final surgery planned within 8 weeks after date of diagnosis
  • Patient fit for surgery
  • Signed patient consent form

Exclusion Criteria:

  • Melanoma on hand, foot, head-neck or ano-genital regions
  • The presence of in-transit- regional and/or distant spread of the disease
  • Illness making patient unfit for surgery
  • Previous malignancies except basal cell- and in-situ colli uteri cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01183936

Sponsors and Collaborators
Karolinska Institutet
Swedish Cancer Society
Stockholm Cancer Society
Investigators
Study Director: Ulrik Ringborg, M.D., Ph.D. Dept of Oncology-Pathology, Karolinska Institute
  More Information

No publications provided by Karolinska Institutet

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT01183936     History of Changes
Other Study ID Numbers: Margins Melanoma, Country specific
Study First Received: August 17, 2010
Last Updated: August 17, 2010
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:
Melanoma/mortality/pathology/*surgery
Randomized Controlled Trials as Topic
Survival
Disease-Free Survival

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on June 18, 2013