Table 1 Comparison of Intergroup 0116, MAGIC and CRITICS trials
| 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 |
