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Trial of Surgical Excision Margins in Thick Primary Melanoma - 2

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.
 
ClinicalTrials.gov Identifier: NCT03638492
Recruitment Status : Completed
First Posted : August 20, 2018
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
Peter Gillgren, Karolinska Institutet

Brief 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.


Condition or disease Intervention/treatment Phase
Melanoma Surgery Treatment Outcome Procedure: 2-cm margin Procedure: 4-cm margin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 936 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-term Follow-up of Survival in Surgical Resected Invasive Cutaneous Melanomas: Comparing 2-cm Versus 4 -cm Resection Margins - a Randomized, Multicenter Trial
Study Start Date : January 1992
Actual Primary Completion Date : May 2004
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Melanoma-specific survival [ Time Frame: 24.9 years ]
    Cause of death: cutaneous malignant melanoma


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 24.9 years ]
    Cause of death: all death causes



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Older Adult)
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

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): NCT03638492


Sponsors and Collaborators
Peter Gillgren
Investigators
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Principal Investigator: Ulrik Ringborg, M.D., Ph.d. Karolinska inteitutet

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Peter Gillgren, Head of Section for Vascular Surgery, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03638492    
Other Study ID Numbers: Margins Melanoma -2
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 Posted: August 20, 2018    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data could be shared with other researchers in a worldwide meta analysis after the actual study is completed.
Keywords provided by Peter Gillgren, Karolinska Institutet:
Melanoma/mortality/pathology/*surgery
Randomized Controlled Trials as Topic
Survival
Margin
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas