About this trial
Patients with histologically confirmed esophagogastric junction adenocarcinoma with pre-operative staging cT3-4N+M0,aged between 18-75 years old, with adequate organ function and having an Eastern Cooperative Oncology Group performance status score ≤2, are randomized in a 1:1:1 ratio to receive neoadjuvant chemoradiotherapy with DT46-50Gy plus concomitant weekly oxaliplatin and 5-Fu, perioperative chemotherapy of FLOT regimen or FOLFOX regimen. The primary end point is disease free survival (DFS), and secondary end point is 5-year overall survival (OS), pathological complete remission (pCR) and treatment safety. The final study analytics are to be conducted at the end of the 5th year after the last patient's enrollment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
informed consensus of the enrolled patients
from 18 to 75 years old
proven to be primary adenocarcinoma of EGJ
pre-operative staging cT3-4N+M0
Disqualifiers
history of other malignancy
allergic reaction to capecitabine or oxaliplatin
enrolled in other clinical trials
abnormal GI tract function
Trial design
Parallel
Treatments tested in this trial
chemoradiation with weekly 5Fu and oxaliplatin
Radiation5Fu 225 mg/m2 IV daily continuous infusion;oxaliplatin 40 mg/m2/week
Perioperative mFLOT
DrugPerioperative docetaxel 50mg/m2;oxaliplatin 85 mg/m2; 5Fu 2.4g/m2 civ 48 hours; repeated every 2 weeks; total of 8 cycles
Perioperative FOLFOX
DrugPerioperative oxaliplatin 85 mg/m2; 5Fu 2.8g/m2 civ 48 hours; repeated every 2 weeks; total of 12 cycles
Treatment groups
Trial outcomes
Primary outcomes
3 year of disease free survival
Secondary outcomes
5 year of overall survival
Rate of pathological complete remission
Anastomosis leak rate
Locations
Sponsors and contacts
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