Table 8. Ongoing clinical trials.
PI/Study name | Study location(s) | Clinicaltrial.gov | Patient population | Sample size | Control arm | Study arm | Study start date | Projected completion date |
---|---|---|---|---|---|---|---|---|
Preoperative | ||||||||
Leong | Australia, Europe, Canada | 1924819 | Stomach Ca | 750 | ECF§ | ECF | 2009 | 2020 |
TOPGEAR (50) | GE jc if <2 cm of esophagus involvement | RT: 45 Gy in 25 fractions | ||||||
T1-2N1 (T2N0 excluded), T3-4N + M0 | ||||||||
D2 dissection recommended | ||||||||
Zhou (52) | China | 1815853 | Stomach Ca | 620 | Cap/Ox‡ | CapOx | 2012 | 2022 |
T4anyNM0 | RT: 45 Gy in 25 fractions | |||||||
Dissection requirement: NA | ||||||||
Postoperative | ||||||||
CRITICS (51) | Netherlands | 407186 | Stomach Ca | 788 | ECC∫ | ECC | 2006 | 2014 |
SIb-IVaM0 | RT: 45 Gy in 25 fractions | |||||||
≥ D1 dissection | ||||||||
Kang (54) | Korea | 323830 | SIb, II, III, IV (T4N3M1nodes) | 458 | XP¶ | XP | 2004 | 2011 |
D2 dissection | RT: NA | |||||||
Kang (55) | Korea | 1761461 | Gastric or gastroesophageal Ca | 1,000 | S1/Ox | S1/Ox | 2013 | 2016 |
ARTIST II | SII/III, N + M0 | RT | ||||||
≥ D2 dissection | ||||||||
Xie (53) | China | 1711242 | Stomach Ca | 300 | Cap/Ox | CapOx | 2012 | 2017 |
T3-4, N + M0 | RT: 45 Gy in 25 fractions | |||||||
D2 dissection |
§, ECF: epirubicin 50 mg/m2 day 1, cisplatin 60 mg/m2 day 1, 5FU 200 mg/m2/day continuous intravenous infusion days 1-21, ×3 cycles preoperative, 3 cycles postoperative. (5FU can be replaced by capecitabine 625 mg/m2 twice daily); ECF/RT, cycle 3 ECF replaced by RT 45 Gy in 25 fractions, 5FU 200 mg/m2/d days 1-35 (5FU can be replaced by capecitabine 625 mg/m2 twice daily); ‡, CapOx: capecitabine 1 g/m2 days 1-14, oxaliplatin 130 mg/m2 day 1, ×2 cycles every 21 days; CapOx/RT, same chemo + RT 45 Gy in 25 fractions; ∫, ECC: epirubicin 50 mg/m2 day 1, cisplatin 60 mg/m2 day 1, capecitabine 1 g/m2 bid days 1-14, every 3 weeks, c3 cycles; ECC/RT, after ECC ×3 cycles, 45 Gy in 25 fractions with cisplatin 20 mg/m2 weekly, capecitabine 575 mg/m2 bid daily during RT; ¶, XP: capecitabine, cisplatin; S1/Ox, S and oxaliplatin; Ca, cancer; GE jc, gastroesophageal junction cancers; 5FU, 5-fluorouracil; RT, radiotherapy; NA, not available.