Table 4.
Adverse events across trial groups (per CTCAE v.4).
| Adverse Event | Standard regimen (41.4 Gy) n (%) | Intensified regimen (50.4 Gy) n (%) | p-values | |
|---|---|---|---|---|
| During Neo-adjuvant chemoradiotherapy | Raised Cr G2+ | 0 (0.0%) | 3 (8.3%) | 0.24b |
| HBT G1+ | 1 (2.9%) | 3 (8.3%) | 0.615b | |
| N/V G3+ | 4 (11.8%) | 5 (13.9%) | 0.999b | |
| Diarrhea | 1 (2.9%) | 4 (11.1%) | 0.358b | |
| Dermatitis G2+ | 1 (2.9%) | 1 (2.8%) | 0.999b | |
| Anemia G2+ | 2 (5.9%) | 5 (13.9%) | 0.430b | |
| Neutropenia G2+ | 6 (17.6%) | 13 (36.1%) | 0.083a | |
| Thrombocytopenia G2+ | 0 (0.0%) | 2 (5.6%) | 0.493b | |
| Esophagitis G3+ | 0 (0.0%) | 2 (5.6%) | 0.493b | |
| After chemoradiotherapy /surgery | Neuropathy G2+ | 1 (2.9%) | 4 (11.1%) | 0.358b |
| Stenosis G3+ | 1 (2.9%) | 6 (16.7%) | 0.107b | |
| Pneumonitis | 2 (5.9%) | 9 (25.0%) | 0.028a | |
| Fistula | 1 (2.9%) | 1 (2.8%) | 0.999b | |
| Abscess | 2 (5.9%) | 1 (2.8%) | 0.609b | |
| Infection | 6 (17.6%) | 5 (13.9%) | 0.666a |
Cr: creatinine; HBT: Hepatobiliary toxicity: N/V: nausea/vomiting.
a
Chi-Squared test.
b
Fisher's Exact test.