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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014