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NCT Number: NCT03034395

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.

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Key information

Conditions

Malignant Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wide Local Excision

Procedure

Surgery

Primary outcomes

  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 outcomes

  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 following surgery

    Time frame: One month post-surgery

    Measured by FACT-Melanoma Surgery Subscale

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jan 27, 2017
Registry last updated
May 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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