Table 1:
Summary of Margin Trials in Melanoma
| Study | Cooperative Group | Country of origin | First Author | Dates of Enrollment | Trial Description | Patients | Primary Outcome | Date Published |
|---|---|---|---|---|---|---|---|---|
| WHO | World Health Organization | EU USA |
Veronesi U | July 1980 – April 1985 | 1cm vs 3cm margins Melanoma <2mm thick Trunk or limbs |
1cm margin: 305 pts 3cm margin: 307 pts |
No difference in OS, DFS All 3 local recurrence in 1cm group in patients with >1mm tumors |
May 5, 1988 |
| Swedish 1 | Swedish Melanoma Study Group | Sweden | Rinborg U | February 1982 – December 1990 | 2cm vs 5cm margins Melanoma 0.8–2mm thick Trunk or limbs |
2cm margin: 373 pts 5cm margin: 396 pts |
No difference in OS, DFS Local recurrences rare (<1%) |
January 5, 1996 |
| Intergroup Melanoma Surgical Trial* | ECOG, SWOG, NSABP, NCI Canada, CALGB | USA Canada |
Balch C | January 1983 – October 1989 | 2cm vs 4cm margin + SLNBx Melanoma 1–4mm thick |
Group A) 2cm margin: 238 pt 4cm margin: 230 pt Group B) 2cm margin head/neck |
No difference in OS, DFS Local recurrence associated with 5% 10-yr survival Head/Neck lesions associated with local recurrence |
April 8, 1993 |
| Swedish 2 | Swedish Melanoma Study Group | Sweden | Gillgren P | January 1992 – May 2004 | 2cm vs 4cm margin + SLNBx Melanoma >2mm thick Trunk or limbs |
2cm margin: 465 pts 4cm margin: 471 pts |
No difference in OS, DFS | October 24, 2011 |
| UK Trial | United Kingdom Melanoma Study Group | United Kingdom | Thomas JM | January 1993 – July 2001 | 1cm vs 3cm margin + SLNBx Melanoma >2mm thick Trunk or limbs |
1cm margin: 453 pts 3cm margin: 447 pts |
Increased local recurrence in 1cm group (HR 1.26 95% CI 1.00–1.59, p=0.05) No difference in OS, DFS |
February 19, 2004 |
| MelMarT1 | Australia & New Zealand Medical Trials Group | Australia New Zealand |
Moncrieff M, Gyorki D | January 2015 – June 2016 | 1cm vs 3cm margin + SLNBx Melanoma >2mm thick Trunk or limbs |
1cm margin: 198 pts 2cm margin: 202 pts |
LR and DSS were not assessed 2cm margin associated with high wound necrosis and reconstruction QoL similar between groups |
May 30, 2018 |
| MelMartTII | Melanoma and Skin Trials Limited | Australia New Zealand | December 2019 – | 1cm vs 2cm margin >2mm or 1–2mm with ulceration |
1cm margin: 1499 (target) 2cm margin: 1499 (target) |
Primary Outcome: DFS Secondary Outcomes: LR, Distant DFS, DSS, OS, QoL, Safety |
ongoing |
Abbreviations: ECOG-Eastern Cooperative Oncology Group, SWOG-Southwestern Oncologu Group, NSABP-National Surgical Adjuvant Breast and Bowel Project, NCI-National Cancer Institute, CALBG-Cancer and Leukemia Group N, USA-United States of America, EU-European Union