Comparing Paclitaxel/Cisplatin and Cisplatin/5-fluorouracil in Neo-CRT for ESCC
Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
This clinical trial has two stages: phase II and phase III. Eligible patients will be
randomized 1:1 to the two arms: paclitaxel plus cisplatin and cisplatin plus 5-fluorouracil.
The phase II stage will enroll 128 patients, 64 patients for each arm. The endpoint of the
phase II stage is complete pathological response (pCR). If the endpoint, i.e., the
significant improvement of pCR rate, is met, the clinical trial will proceed to the phase III
stage, in which 120 more patients will be enrolled. The estimated enrollment time is four
years with 3 more years of follow-up after completing enrollment. The primary endpoint of the
clinical trial is overall survival, and the secondary endpoints include clinical response,
disease free survival, operation rate, complete resection rate, tumor regression rate,
hospital stay days after surgery, safety and toxicity, and quality of life.