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

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University of Kansas

Status

Completed

Conditions

Malignant Melanoma

Treatments

Procedure: Wide Local Excision

Study type

Interventional

Funder types

Other

Identifiers

NCT03034395
IIT-2016-JM-MEL-T2Margins

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

15 participants in 2 patient groups

Wide Local Excision 1cm
Other group
Treatment:
Procedure: Wide Local Excision
Wide Local Excision 2cm
Other group
Treatment:
Procedure: Wide Local Excision

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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