Malignant Melanoma
Conditions
Keywords
Melanoma, cT2N0M0
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.
Interventions
PROCEDUREWide Local Excision
Surgery
Sponsors
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed