NCT03961841

Perioperative Combination Chemotherapy Versus Chemoradiation for Locally Advanced EGJ Adenocarcinoma

A Randomised Controlled Trial Comparing Perioperative FLOT, FOLFOX and Preoperative Chemoradiation for Locally Advanced Esophagogastric Junction Adenocarcinoma

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 900 (estimated)
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophagogastric Junction Disorder
• Neoplasms

Interventions

Type	Name	Description
RADIATION	chemoradiation with weekly 5Fu and oxaliplatin	5Fu 225 mg/m2 IV daily continuous infusion；oxaliplatin 40 mg/m2/week
DRUG	Perioperative mFLOT	Perioperative docetaxel 50mg/m2；oxaliplatin 85 mg/m2; 5Fu 2.4g/m2 civ 48 hours; repeated every 2 weeks; total of 8 cycles
DRUG	Perioperative FOLFOX	Perioperative oxaliplatin 85 mg/m2; 5Fu 2.8g/m2 civ 48 hours; repeated every 2 weeks; total of 12 cycles

Timeline

• Start date: 2020-06-01
• Primary completion: 2024-08-01
• Completion: 2029-08-01
• First posted: 2019-05-23
• Last updated: 2019-12-23