Details of the 3 Randomized Clinical Trials (RCTs) (Primary and Follow-Up Studies) of Patients With Malignant Melanoma of the Extremities Who Underwent Wide or Narrower Excision
| Series | Methods | Participants | Interventions | Outcomes |
|---|---|---|---|---|
| Veronesi et al, 1988 (12) (primary study) | Multicentre international RCT Blinding of: randomization: yes intervention: no outcome measuremes: no Complete follow-up: no (1 lost) | 612 adults with cutaneous melanoma up to 2 mm Breslow thickness | 307 patients treated with 3-cm margin v. 305 with 1-cm margin of excision. Age, sex, Breslow thickness, ulceration, anatomic site similar | 55 mo OS, DFS and LRR |
| Veronesi et al, 1991 (15) (follow-up study) | Follow-up to Veronesi et al 1988 primary study | Same as Veronesi et al 1988 | Same as Veronesi et al 1988 | 8 yr OS, DFS and LRR |
| Balch et al, 1993 (13) (primary study) | Multicentre, international RCT Blinding of: randomization: not stated intervention: no outcome measures: only for local recurrence Complete follow-up: no (2.3% lost) | 486 adults with cutaneous melanoma 1–4 mm Breslow thickness | 242 patients treated with 4-cm margin v. 244 with 2-cm margin of excision. Age, sex, Breslow thickness, ulceration, anatomic site similar | 5 yr OS, median 6 yr LRR Wound complications Need for skin graft LOHS |
| Balch et al, 2001 (16) (follow-up study) | Follow-up to Balch et al 1993 primary study | Same as Balch 1993 | Same as Balch et al 1993 | 10 yr mean OS and LRR |
| Ringborg et al, 1996 (14) (primary study) | Multicentre, international RCT Blinding of: randomization: yes intervention: no outcome measurements: can’t tell for recurrence Complete follow-up: yes | 769 adults with cutaneous melanoma 0.8–2 mm Breslow thickness | 396 patients treated with 5-cm margin v. 373 with 2-cm margin of excision. Age, sex, Breslow thickness, ulceration, anatomic site similar | 5 yr OS, 5 yr melanoma survival, median 4 yr DFS, median 4 yr LRR |
| Cohn-Cedermark et al, 2000 (17) (follow-up study) | Follow-up to Ringborg et al 1996 primary study with added patients | 989 adults with cutaneous melanoma | 513 patients treated with 5-cm margin v. 476 with 2-cm margin of excision | 11 yr OS and melanoma survival 8 yr DFS and LRR |
LOHS = length of hospital stay, OS = overall survival, LRR = local recurrence rate, DFS = disease-free survival.