Melanoma Margins Trial-II: 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma
Condition(s) studied
Investigational drug(s) / intervention(s)
Wide Local Excision = 1cm Margin: A wide local excision involves removing an extra "safety margin" of skin surrounding the original melanoma site, to ensure that any remaining scattered melanoma tumour cells that may have been left behind after the first initial biopsy/surgery are removed.
Wide Local Excision = 2cm Margin: A wide local excision involves removing an extra "safety margin" of skin surrounding the original melanoma site, to ensure that any remaining scattered melanoma tumour cells that may have been left behind after the first initial biopsy/surgery are removed.
Study summary
Patients with a primary invasive melanoma are recommended to undergo excision of the primary lesion with a wide margin. There is evidence that less radical margins of excision may be just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the primary lesion for adult patients with stage II primary invasive cutaneous melanomas (AJCC 8th edition) to determine differences in disease-free survival. A reduction in margins is expected to improve patient quality of life.
Eligibility
Primary outcome measure(s)
- Disease-Free Survival — 0-60 months
Time from randomisation until the first clinically, histologically or radiologically confirmed recurrence of melanoma at any body site, or death from any cause.
Trial sites (192)
| Facility | City | Region | Status |
|---|---|---|---|
| University of South Alabama Mitchell Cancer Institute | Mobile | Alabama | Recruiting |
| Banner MD Anderson Cancer Center | Gilbert | Arizona | Recruiting |
| Mayo Clinic Phoenix | Phoenix | Arizona | Recruiting |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | Recruiting |
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care | Irvine | California | Recruiting |
| Los Angeles General Medical Center | Los Angeles | California | Recruiting |
| Los Angeles General Medical Center | Los Angeles | California | Recruiting |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | Recruiting |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | Recruiting |
| The Angeles (Cedars-Sinai Medical Center and its Affiliates) | Los Angeles | California | Recruiting |
| UC Irvine Health - Chao Family Comprehensive Cancer Center | Orange | California | Recruiting |
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care | Orange | California | Recruiting |
| Stanford Cancer Institute | Palo Alto | California | Recruiting |
| Huntington Memorial Hospital | Pasadena | California | Recruiting |
| Stanford Cancer Center South Bay | San Jose | California | Recruiting |
| Kaiser Permanente - Vallejo Medical Center | Vallejo | California | Recruiting |
| Kaiser Permanente - Walnut Creek Medical Center | Walnut Creek | California | Recruiting |
| Smilow Hospital Care Center, Guilford | Guilford | Connecticut | Recruiting |
| Yale University | New Haven | Connecticut | Recruiting |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | Recruiting |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | Recruiting |
| University of Miami Sylvester Comprehensive Cancer Center at Aventura | Aventura | Florida | Recruiting |
| University of Miami Sylvester Comprehensive Cancer Center at Coral Gables | Coral Gables | Florida | Recruiting |
| University of Miami Sylvester Cancer Center at Coral Springs | Coral Springs | Florida | Recruiting |
| University of Miami Sylvester Comprehensive Center at Deerfield Beach | Deerfield Beach | Florida | Recruiting |
| University of Miami Sylvester Comprehensive Center at Hollywood | Hollywood | Florida | Recruiting |
| Baptist MD Anderson Cancer Center | Jacksonville | Florida | Recruiting |
| Mayo Clinic in Florida | Jacksonville | Florida | Recruiting |
| Lakeland Regional Health Hollis Cancer Center | Lakeland | Florida | Recruiting |
| University of Miami Miller School of Medicine-Sylvester Cancer Centre | Miami | Florida | Recruiting |
| University of Miami Comprehensive Cancer Center at Kendall | Miami | Florida | Recruiting |
| University of Miami Comprehensive Cancer Center at Plantation | Plantation | Florida | Recruiting |
| Moffitt Cancer Center - McKinley Campus | Tampa | Florida | Recruiting |
| Moffitt Cancer Center, Magnolia Campus | Tampa | Florida | Recruiting |
| Emory University Hospital Midtown | Atlanta | Georgia | Recruiting |
| Emory University | Atlanta | Georgia | Recruiting |
| Emory Saint Joseph's Hospital | Atlanta | Georgia | Recruiting |
| Northside Hospital Atlanta | Atlanta | Georgia | Recruiting |
| Northside Hospital Cancer Institute | Atlanta | Georgia | Not Yet Recruiting |
| Nancy N and JC Lewis Cancer & Research Pavilion St. Joseph's/Candler | Savannah | Georgia | Recruiting |
+ 152 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03860883 on ClinicalTrials.gov ↗ ← All trials in Italy