Study of 1cm Versus 2cm Margins for the Surgical Treatment of cT2N0M0 Melanoma
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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
Sex
Ages
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
Allocation
Interventional model
Masking
15 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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