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Trial of Surgical Excision Margins in Thick Primary Melanoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01183936
First Posted: August 18, 2010
Last Update Posted: August 18, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Swedish Cancer Society
Stockholm Cancer Society
Information provided by:
Karolinska Institutet
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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): 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

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 ( Other Identifier: Swe; Nat Reg Nr, Dk; 5 dig ser nr (8XXXX), Ea; 5 dig ser nr (7XXXX), Ny; 4 dig ser nr (9XXX) )
First Submitted: August 17, 2010
First Posted: August 18, 2010
Last Update Posted: August 18, 2010
Last Verified: June 1991

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