Study of 1cm Versus 2cm Margins for the Surgical Treatment of cT2N0M0 Melanoma
| Status: | Recruiting |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/8/2019 |
| Start Date: | January 30, 2017 |
| End Date: | January 2020 |
| Contact: | Kerry Hepler, RN |
| Email: | ctnursenav@kumc.edu |
| Phone: | 913-945-7552 |
Pilot Study of 1cm Versus 2cm Margins for the Surgical Treatment of cT2N0M0 Melanoma
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.
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.
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.
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.
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
We found this trial at
1
site
3901 Rainbow Blvd
Kansas City, Kansas 66160
Kansas City, Kansas 66160
(913) 588-5000
Phone: 913-945-7552
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
Click here to add this to my saved trials
