Table 2 Ongoing phase II and III trials in locally advanced gastroesophageal adenocarcinoma
Trial | Setting | N (To be enrolled) | Location | Primary endpoint | Intervention | Expected completion date |
|---|---|---|---|---|---|---|
Alderson et al.[30], 2013 | Neoadjuvant | 842 | Esophageal | Survival and QOL | A: C (ECX x 4) → S | NR |
MRC OEO5 |  |  | EGJ I-II |  | B: C (CFx2) → S |  |
Kang et al.[35], 2013 | Adjuvant CRT | 1000 | Gastric and EGJ | DFS (3 years) | A: S → C (S1) | January 2016 |
NCT01761461 |  |  |  |  | B: S → C (S1x1) → CRT (S1) → C (S1x6) |  |
‘ARTIST II’ |  |  |  |  | C: S → C (SOX) |  |
|  |  |  |  |  | D: S → C (SOX) → CRT (S1) → C (SOXx4) |  |
Lorenzen et al.[53], 2010 | Neoadjuvant CRT | NR | Resectable EGJ (I-II) | Â | Non-randomized, single institution | Not initiated |
NCT01271322 |  |  |  |  | A: C (Cisplatin/Taxotere) → PET |  |
‘HICON’ Trial (Phase II) |  |  |  |  | If Response: Continue C |  |
| Â | Â | Â | Â | Â | If No response: Cross to Arm B | Â |
|  |  |  |  |  | B: Taxane based CRT (45 Gy) → PET |  |
| Â | Â | Â | Â | Â | If Response: CRT (TP x 3) | Â |
| Â | Â | Â | Â | Â | If No response: Cross to Arm A | Â |
Goodman et al.[54], 2013 | Neoadjuvant CRT | 204 | Esophageal and EGJ I and II | pCR | A: C (FOLFOX x 3) → PET | September 2011 |
NCT01333033 | Â | Â | Â | Â | If Response: CRT (FOLFOX x 3) | Â |
CALGB 80803 (Phase II) | Â | Â | Â | Â | If No response: Cross to Arm B | Â |
|  |  |  |  |  | B: C (TP x 3) → PET |  |
| Â | Â | Â | Â | Â | If Response: CRT (TP x 3) | Â |
| Â | Â | Â | Â | Â | If No response: Cross to Arm A | Â |
Nordwest et al.[74], 2012 | Perioperative | 590 | Gastric EGJ I-III | DFS (2 years) | A: C (FLOTx4) → S (D2) → C (FLOTx4) | July 2015 |
NCT01216644 |  |  |  |  | B: C (ECFx3) → S (D2) → C (ECFx3) |  |
‘FLOT4’ |  |  |  |  |  |  |
Chen et al.[72], 2012 | Perioperative | 722 | Gastric EGJ II or III | DFS (3 years) | A: C (SOX) → S (D2) → C (SOX) | September 2014 |
NCT01583361 |  |  |  |  | B: S (D2) → C (SOX) |  |
‘RESONANCE’ |  |  |  |  |  |  |
Shen et al.[73], 2012 | Perioperative | 1059 | Gastric EGJ I-III | DFS (3 years) | A: S (D2) → C (SOXx8) | September 2014 |
NCT01534546 |  |  |  |  | B: S (D2) → C (XELOXx8) |  |
|  |  |  |  |  | C: C (SOXx3) → S (D2) → C (SOXx5) → C (S-1x3) |  |
Reynolds et al.[60], 2013 | Perioperative | 366 | Esophageal EGJ (I-III) | OS (3 years) | A: C (ECF) → S → C (ECF) | September 2021 |
NCT01726452 |  |  |  |  | B: CRT (TP) → S |  |
‘MAGIC vs. CROSS EGJ’ |  |  |  |  |  |  |
Verheji et al.[61], 2011 | Perioperative CRT | 788 | Gastric | OS | A: C (ECCx3) → S (D1+) → CRT (CC, 45Gy) | June 2013 |
NCT00407186 CRITICS Trial |  |  |  |  | B: C (ECCx3) → S (D1+) → C (ECCx3) |  |
Leong et al.[62], 2013 | Peri-operative CRT | 752 | Gastric EGJ | OS | A: C (ECF/Xx2) → CRT (5-FU/RT) → S → C (ECF/Xx3) | NR |
‘TOP GEAR’ (Australia) |  |  |  |  | B: C (ECF/Xx3) → S → C (ECF/Xx3) |  |
Molecularly targeted trials | ||||||
Safran et al.[67], 2013 | Neoadjuvant CRT | 480 | Mid and Distal Esophagus including EGJ | DFS | A: CRT (TP) → S → T (13) | August 2018 |
NCT01196390 |  |  |  |  | B: CRT (TP) → S |  |
RTOG 1010 | Â | Â | Â | Â | Â | Â |
Reed et al.[68], 2012 | Neoadjuvant CRT | 69 | Distal Esophagus and EGJ | pCR | CRT (CDP) → S | Study Completed |
NCT00757172 | Â | Â | Â | Â | Â | Â |
ACASOG Z4051 | Â | Â | Â | Â | Â | Â |
Phase II | Â | Â | Â | Â | Â | Â |
Ilson et al.[69], 2012 | Neoadjuvant CRT | 420 | Esophageal (Squamous allowed) GEJ I-II | OS | A: CRT (CCT, 50.4Â Gy) | August 2018 |
NCT00655876 | Â | Â | Â | Â | B: CRT (CT, 50.4Â Gy) | -Closed at interim analysis for AC arm due to low clinical complete response |
RTOG 0436 | Â | Â | Â | Â | Â | -Closed SCC arm due to SCOPE-1 results (see text) |
Cunningham et al.[75], 2012 | Perioperative | 1100 | Gastric EGJ I-III | OS, Safety, Efficacy | A: C (ECXB) → S → C (ECXB) | December 2014 |
NCT00450203 | Â | Â | Â | Â | Â | Â |
‘MAGIC-B’ (ST03) |  |  |  |  | B: C (ECX) → S → C (ECX) |  |