Table 3.
Ref. | Phase | Selection criteria | Study arms | No. of patients | R0 resection (%) | Pathologic CR (%) | Median survival (mo) |
Zhang et al[36] | RCT | EGJ | 40 Gy EBRT + surgery vs surgery alone | 370 (171 + 199) | 89.5 | 0 | 5-yr OS 30% vs 20% |
Shchepotin et al[37] | RCT | M0 resectable and unresectable | Surgery alone vs 20 Gy EBRT vs 20 Gy EBRT + Hy | 293 (98 + 100 + 95) | NS | NS | 5-yr OS 21.3% |
Skoropad et al[38] | RCT | M0 resectable + EGJ | 20 Gy EBRT + Hy + 20 Gy IORT vs surgery alone | 122 (59 + 53) | 66 | 0 | 16 |
Safran et al[39] | Phase I | Unresectable M0 | 45 Gy EBRT+ Paclitaxel | 27 | NS | 11 | 2-yr OS 35% |
Lowy et al[40] | Phase I | T > 2, Any N, M0 | 45 Gy EBRT, 5-FU | 24 | 75 | 11 | NS |
Ajani et al[41] | Phase II | T > 2, Any N | 5FU, LV, P + 45 Gy EBRT, 5FU | 33 | 70 | 30 | 34 |
Ajani et al[42] | Phase II | M0 resectable + EGJ | FP, paclitaxel + 45 Gy EBRT, 5FU | 41 | 78 | 20 | > 36 |
Allal et al[43] | Phase I | T3-T4, N+ | FP, Leucovorin + 31.2–45.6 Gy EBRT | 19 | NS | 5 | 5-yr OS 35% |
Ajani et al[44] | Phase II | M0 resectable | FP, LV, P + 45 Gy EBRT, 5FU, cis | 49 | 63 | 26 | 23 |
Stahl et al[45] POET trial | Phase III RCT | EGJ | PFL × 3 + 30 Gy + cisplatin/etoposide + surgery vs PFL × 2, 5 + surgery | 126 (62+64) | 72 vs 69 | 15.6 vs 2.0 | 33.1 vs 21.1 |
Van Hagen et al[48] CROSS trial | Phase III RCT | Esophageal or EGJ cancer | Carboplatin + paclitaxel + 41.1Gy + surgery vs surgery alone | 366 (178 + 188) | 92 vs 69 | 29 (CRT + surgery) | 49.9 vs 24 |
R0: Curative (R0) resections; CR: Complete response; GEJ: Gastro-esophageal junction; RCT: Randomized controlled trial; EBRT: External beam radiotherapy; IORT: Intraoperative radiotherapy; Hy: Hypertermia; FP: Fluorouracil and cisplatin; LV: Leucovorin; NS: Not stated; OS: Overall survival.