Clinical Trial

Perioperative Combination Chemotherapy Versus Chemoradiation for Locally Advanced EGJ Adenocarcinoma

Not Yet Recruiting Phase 3
View on ClinicalTrials.gov →
Record status
This record was last updated December 23, 2019 (before its estimated August 2024 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2019-05-22.
Trial Details
NCT Number NCT03961841
Lead Sponsor Sixth Affiliated Hospital, Sun Yat-sen University
Conditions Esophagogastric Junction Disorder, Neoplasms
Enrollment 900 participants
Start Date 2020-06
Primary Completion 2024-08 (estimated)
Study Completion 2029-08 (estimated)
Updated on ClinicalTrials.gov 2019-12-23