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

Not Applicable

Completed

• Conditions: Malignant Melanoma
• Interventions: Procedure: Wide Local Excision

• Registration Number: NCT03034395
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-01-23
• Study First Submitted QC: 2017-01-26
• Study First Posted: 2017-01-27
• Study Start: 2017-01-30
• Primary Completion: 2019-05-03
• Study Completion: 2020-11-04
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-29
• Last Update Posted: 2021-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wide Local Excision 1cm	Wide Local Excision	-
Wide Local Excision 2cm	Wide Local Excision	-

Primary Outcome Measures

Name	Time	Method
Number of participants who agree to blinded randomization to a surgical margin trial for the treatment of early stage melanoma.	2 years	Number of patients who agree to participate

Secondary Outcome Measures

Name	Time	Method
Recurrence (disease free survival)	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.
Quality of life following surgery	One month post-surgery	Measured by FACT-Melanoma Surgery Subscale

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States