Main characteristics of randomized clinical trials on colon cancer
| Variable | COLOR (10), (14) | COST (16), (17) | CLASICC (11), (20), (21)* | LAPKON II (26) | ALCCaS (27) | Barcelona (22), (23) | Liang (24) | LAFA-study (25)† |
|---|---|---|---|---|---|---|---|---|
| Study design, Phase III | multi | multi | multi | multi | multi | single | single | multi |
| Concealment | Computer-generated random numbers | Centralized | Centralized by telephone | Centralized by telephone Revealed during operation | Centralized | Sealed envelopes | Random-sized blocks 2–10 | 2 × 2 Internet randomization module |
| Median follow-up, mo. | 53 | 60 | 37 | § | § | 43 | 40 | — |
| Primary outcomes | 3-year DFS | Time to recurrence | 3-year DFS 3-year OS LR | § | § | Cancer-related survival | Time to recurrence | Total postop hospital stay |
| Level of evidence‡ | I | I | I | I | I | II | II | I |
| Population, no | ||||||||
| OP | 542 | 428 | 140 | 222 | 298 | 102 | 134 | 108 |
| LAP | 534 | 435 | 273 | 250 | 294 | 106 | 135 | 110 |
| Tumour stage | ||||||||
| I | 24% | 26% (OP) 35% (LAP) | NA | 28% (OP) 35% (LAP) | 23% | 22% | — | NA |
| II | 43% | 34% (OP) 31% (LAP) | NA | 38% (OP) 32% (LAP) | 40% | 43% | 49% | NA |
| III | 33% | 28% (OP) 26% (LAP) | NA | 33% (OP) 33% (LAP) | 30% | 35% | 51% | NA |
| IV | — | 4% (OP) 2% (LAP) | NA | — | 2% | — | — | NA |
| Postoperative chemotherapy | According to surgeon (p = 0.99) | According to surgeon | 29% (OP) 28% (LAP) | NA | NA | 55% (OP) 61% (LAP) | For stage III patients | NA |
| Surgery | ||||||||
| Surgical procedure | ||||||||
| Right | 47% | 54% | 45% | 29% | 58% | 45% | — | 48% |
| Left | 11% | 7% | 13% | ¶ | 4% | 2% | 70% | 49% |
| Sigmoid | 38% | 38% | 21% | ¶ | — | 45% | 30% | — |
| Anterior | — | — | 11% | — | 38% | 5% | — | — |
| Conversion rate | 19% | 21% | 25% | 11% | 15% | 11% | 3% | 11% |
| Surgeon experience | ≥ 20 LAP colectomies | ≥ 20 LAP colectomies | ≥ 20 LAP resections | ≥ 20 LAP colectomies | 52% surgeons treated > 10 patients | Experienced team | Experienced surgeon | ≥ 20 LAP for benign disease |
CLASICC = Conventional Versus Laparoscopic-Assisted Surgery in Patients with Colorectal Cancer; COLOR = Colon Cancer Laparoscopic or Open Resection; COST = Clinical Outcomes of Surgical Therapy; DFS = disease-free survival; LAP = laparoscopy; LR = local recurrence; multi = multicentred; NA = not available; OP = open surgery; OS = overall survival; single = single-centred.
↵* This trial included patients with colon and rectum cancers. When available, only data specific to colon cancer are presented.
↵† This trial evaluated fast-track versus standard care and LAP versus OP (4 arms). Only the 2 arms with standard care (LAP v. OP) are presented.
↵‡ As evaluated according to the American Society of Clinical Oncology and European Society for Medical Oncology gradation system (see Table 1).
↵§ Only short-term outcomes are published.
↵¶ 71% for left plus rectosigmoid.