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Table 1 Comparison of Intergroup 0116, MAGIC and CRITICS trials

From: Neo-adjuvant chemotherapy followed by surgery and chemotherapy or by surgery and chemoradiotherapy for patients with resectable gastric cancer (CRITICS)

  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
  1. A: experimental arm
  2. B: control arm
  3. GEJ: gastro-oesophageal junction
  4. 5-FU: 5-fluorouracil
  5. LV: leucovorin
  6. RT: radiotherapy (always 25 × 1.8 Gy in 5 weeks)
  7. CC: capecitabine/cisplatin
  8. ECC: epirubicin/cisplatin/capecitabine
  9. EOC: epirubicin/oxaliplatin/capecitabine
  10. CTV: clinical target volume
  11. GOJ: gastro oesophageal junction
  12. OS: overall survival
  13. D1+ resection: removal of stations 1-9 and 11, at least 15 lymph nodes, no routine splenectomy
  14. R0: microscopically radical