Table 3.
Main characteristics of randomized clinical trials on rectal cancer
| Variable | Liang33 | COREAN34 | CLASICC11,20,21* | Lujan36 | Ng37,38 | Ng39 | Pechlivanides40 | Braga41* | Zhou42 |
|---|---|---|---|---|---|---|---|---|---|
| Study design, Phase III | single | multi | multi | single | single | single | multi | single | single |
| Concealment | Opaque envelopes | Computer-generated | Centralized, by phone | Computer-generated | Computer-generated | Computer-generated | Computer-generated | Computer-generated | NA |
| Median follow-up, mo. | 44 | NA | 37 | 34 (OP) 33 (LAP) |
113 (OP) 109 (LAP) |
91 (OP) 87 (LAP) |
NA | 54 | NA |
| Primary outcomes | 3-year OS | DFS | 5-year DFS, 5-year OS, LR | No. lymph nodes retrieved, integrity of mesorectal resection margin | Long-term morbidity | Postoperative recovery | No. lymph nodes retrieved | Short-term postopmorbidity | Short-term results |
| Level of evidence† | I | I | I | I | I | I | I | I | I |
| Population, no | |||||||||
| OP | 174 | 170 | 128 | 103 | 77 | 48 | 39 | 89 | 89 |
| LAP | 179 | 170 | 253 | 101 | 76 | 51 | 34 | 82 | 82 |
| Tumour stage | |||||||||
| I | NA | NA | NA | 15% (OP) 11% (LAP) |
15% (OP) 17% (LAP) |
NA | NA | NA | NA |
| II | NA | NA | NA | 38% (OP) 35% (LAP) |
38% (OP) 38% (LAP) |
NA | NA | NA | NA |
| III | NA | NA | NA | 43% (OP) 45% (LAP) |
26% (OP) 36% (LAP) |
NA | NA | NA | NA |
| IV | NA | NA | NA | 5% (OP) 10% (LAP) |
21% (OP) 9% (LAP) |
NA | NA | NA | NA |
| Postoperative chemotherapy | NA | Recommended for 4 mo | 29% (OP) 28% (LAP) |
Stage III or IV disease | 33% (OP) 14% (LAP) |
NA | NA | NA | NA |
| Surgery | |||||||||
| Tumour distance from AV, cm | NA | 5.3 (OP) 5.6 (LAP) |
NA | 6.2 (OP) 5.5 (LAP) |
12–15 cm | ≥ 5 cm | 8 (OP) 6 (LAP) |
8.6 (OP) 9.1 (LAP) |
NA |
| Conversion rate | < 1% | 1% | 34% | 8% | 30% | 10% | 3% | 7% | NA |
| Surgeon experience | Experienced surgeon | 28–150 LAP | ≥ 20 LAP | Experienced team | Experienced surgeon | Experienced surgeon | Experienced surgeon | Experienced team | Experienced surgeon |
AV = anal verge; CLASICC = Conventional Versus Laparoscopic-Assisted Surgery in Patients with Colorectal Cancer; COREAN = Comparison of Open versus laparoscopic surgery for mid and low Rectal cancer After Neoadjuvant chemoradiotherapy; DFS = disease-free survival; LAP = laparoscopy; LR = local recurrence; NA = not available; OP = open surgery; OS = overall survival.
*
This trial included patients with colon and rectum cancers. When available, data specific to rectal cancer are presented.
†
As evaluated according to the American Society of Clinical Oncology and European Society for Medical Oncology gradation system (Table 1).