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

April 29, 2021 updated by: University of Kansas Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Wide Local Excision 1cm
Procedure: Wide Local Excision
Surgery
OTHER: Wide Local Excision 2cm
Procedure: Wide Local Excision
Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Every 4 months post-surgery for 2 years and then every 4-6 months for an additional 3 years
Quality of life following surgery
Time Frame: One month post-surgery
Measured by FACT-Melanoma Surgery Subscale
One month post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Investigators

  • Principal Investigator: Joshua Mammen, MD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 30, 2017

Primary Completion (ACTUAL)

May 3, 2019

Study Completion (ACTUAL)

November 4, 2020

Study Registration Dates

First Submitted

January 23, 2017

First Submitted That Met QC Criteria

January 26, 2017

First Posted (ESTIMATE)

January 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 3, 2021

Last Update Submitted That Met QC Criteria

April 29, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT-2016-JM-MEL-T2Margins

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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