Table 5.
Parameter | CRSOSS | NEOCRTE 5010 |
---|---|---|
number of patients | 368 | 451 |
patient inclusion | esophageal adenocarcinoma (75%) and squamous cell carcinoma (25%) | esophageal squamous cell carcinoma (100%) |
chemotherapy regimen | Carboplatin + Paclitaxel | vinorelbine + Cisplatin |
radiation dose | 41.4 Gy/23F | 40 Gy/20F |
radiation technique | three-dimensional conformal | three-dimensional conformal |
photon energies | equal to or greater than 6 MV | 6-8MV |
GTV | the primary tumor and any enlarged regional lymph nodes | primary tumor and any enlarged regional lymph nodes |
CTV | a 1.5 cm radial margin around the GTV | a proximal and distal margin of 3 cm and a 0.5- to 1.0-cm radial margin around the GTV |
PTV | a proximal and distal margin of 4 cm, in case of tumor extension into the stomach, a distal margin of 3 cm will be chosen | an 8-mm margin of the clinical target volume |
primary endpoint | OS | OS |
pCR rate | 29% | 43.2% |
median DFS | 23 months | 100.1 months |
OS results | 47% at 5 years | 59.9% at 5 years |
Abbreviations: GTV gross tumor volume, CTV clinical target volume, PTV planning target volume, OS overall survival, DFS disease-free survival, pCR pathological complete response