drugset / Trial / NCT03961841

Perioperative Combination Chemotherapy Versus Chemoradiation for Locally Advanced EGJ Adenocarcinoma

NCT03961841 ↗

Phase 3 Not yet recruiting 900 enrolled Sixth Affiliated Hospital, Sun Yat-sen University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2020-06
Primary completion
2024-08
Completion
2029-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 50 mg/m2 —
Subject Oxaliplatin Small molecule 85 mg/m2 —
Subject fluorouracil Small molecule 2.4 g Intravenous
Subject fluorouracil Small molecule 2.8 g Intravenous