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Study of 1cm Versus 2cm Margins for the Surgical Treatment of cT2N0M0 Melanoma

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ClinicalTrials.gov Identifier: NCT03034395
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
University of Kansas Medical Center

Brief Summary:
This is a randomized non-blinded pilot study for patients with melanoma staging cT2N0M0 who are candidates for surgical resection. The primary objective is to determine the feasibility of randomizing participants with cT2N0M0 malignant melanoma to surgical treatment with 1cm versus 2cm margins. Study will try to determine overall survival for cT2N0M0 malignant melanoma after surgical treatment with 1cm versus 2cm margins.

Condition or disease Intervention/treatment Phase
Malignant Melanoma Procedure: Wide Local Excision Not Applicable

Detailed Description:
After randomization, participants will undergo surgery with wide local excision with either 1cm or 2cm margins. The margin will be based upon the previous biopsy site or area of pigmentation. The skin and subcutaneous tissue (down to fascia) will be resected. Closure considerations may require removal of additional tissue for non-oncologic purposes. As per standard of care, sentinel lymph node biopsy will be performed using a dual tracer technique (technetium radiolabeled sulfur colloid and isosulfan blue) with or without lymphoscintigraphy.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of 1cm Versus 2cm Margins for the Surgical Treatment of cT2N0M0 Melanoma
Actual Study Start Date : January 30, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Arm Intervention/treatment
Wide Local Excision 1cm Procedure: Wide Local Excision
Surgery
Wide Local Excision 2cm Procedure: Wide Local Excision
Surgery



Primary Outcome Measures :
  1. Number of participants who agree to blinded randomization to a surgical margin trial for the treatment of early stage melanoma. [ Time Frame: 2 years ]
    Number of patients who agree to participate


Secondary Outcome Measures :
  1. Recurrence (disease free survival) [ Time Frame: Every 4 months post-surgery for 2 years and then every 4-6 months for an additional 3 years ]
    Subjects will be evaluated at 4 month intervals for 2 years and then at 4-6 month intervals for an additional 3 years to evaluate for evidence of disease recurrence.

  2. Quality of life [ Time Frame: One month post-surgery ]
    Measured by FACT-Melanoma Surgery Subscale



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy proven T2 malignant melanoma.
  • Eastern Cooperative Oncology Group (ECOG) score of 0-2.

Exclusion Criteria:

  • Visible additional disease that suggests a greater than T2 malignant melanoma
  • Unable to tolerate general anesthesia
  • Evidence of distant metastatic disease
  • Melanoma located on face or digits

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): NCT03034395


Contacts
Contact: Kerry Hepler, RN 913-945-7552 ctnursenav@kumc.edu
Contact: Sherri Miller

Locations
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Kerry Hepler, RN    913-945-7552    ctnursenav@kumc.edu   
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
Principal Investigator: Joshua Mammen, MD University of Kansas Medical Center

Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03034395     History of Changes
Other Study ID Numbers: IIT-2016-JM-MEL-T2Margins
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017

Keywords provided by University of Kansas Medical Center:
Melanoma
cT2N0M0

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