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

Malignant Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03034395
• Other study ID #: IIT-2016-JM-MEL-T2Margins
• Status: Completed
• Phase: N/A
• Start date: January 30, 2017
• Est. completion date: November 4, 2020

Study information

• Verified date: April 2021
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 4, 2020
• Est. primary completion date: May 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Intervention

Procedure:
• Wide Local Excision
Surgery

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who agree to blinded randomization to a surgical margin trial for the treatment of early stage melanoma.	Number of patients who agree to participate	2 years
Secondary	Recurrence (disease free survival)	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
Secondary	Quality of life following surgery	Measured by FACT-Melanoma Surgery Subscale	One month post-surgery