Table 1 Comparison of Intergroup 0116, MAGIC and CRITICS trials
| Â | Intergroup 0116[8] | MAGIC[9] | CRITICS |
|---|---|---|---|
General | |||
Accrual | 1991 - 1998 | 1994 - 2002 | 2007 - |
Number of patients | 556 | 503 | 788 (needed) |
Randomization | after R0 surgery | after diagnosis (before any treatment) | after diagnosis (before any treatment) |
Inclusion | |||
Histology | Adenocarcinoma | Adenocarcinoma | Adenocarcinoma |
Location | GOJ/Stomach | Lower 1/3 oesophagus/GOJ/Stomach | GOJ (bulk tumour in stomach)/Stomach |
Stage | IB-IV (M0) | II-IV (M0) | IB-IV (M0) |
Preoperative Therapy | |||
Preoperative therapy | not applicable | A: ECF (3 courses) B: none | A: ECC/EOC (3 courses) B: ECC/EOC (3 courses) |
Completed preoperative therapy | not applicable | 86% | ongoing |
Surgery | |||
Surgery | D0 gastrectomy: 54% D1 gastrectomy: 36% D2 gastrectomy: 10% | oesophagogastrectomy: 23% D1 gastrectomy: 19% D2 gastrectomy: 40% non-curative/unknown: 18% | ongoing |
R0 resection | 100% (if R1/R2: no inclusion) | A: 69.3% B: 66.4% | ongoing |
Postoperative Therapy | |||
Postoperative Therapy | A: 5-FU/LV/RT (45Gy) B: none | A: ECF (3 courses) B: none | A: CC/RT (45Gy) B: ECC/EOC (3 courses) |
Completed postoperative therapy | 64% | 42% | ongoing |
Quality Assurance | |||
Surgery | D2 recommended Postoperative analysis of extent of LN dissection | not reported | D1+ resection Regular feedback to individual surgeons and pathologists |
Radiotherapy | Central review of RT plan Major deviations corrected | not applicable | Central review of at least first 3 RT plans of each center CTV contouring atlas available |
Results | |||
Primary endpoint | Overall Survival | Overall Survival | Overall Survival |
Result primary endpoint (experimental versus control) | A: 42% 5-year OS B: 25% 5-year OS | A: 36% 5-year OS B: 23% 5-year OS | ongoing |