Perioperative Combination Chemotherapy Versus Chemoradiation for Locally Advanced EGJ Adenocarcinoma

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSixth Affiliated Hospital, Sun Yat-sen University

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

Qualifiers

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

Treatments tested in this trial

  • chemoradiation with weekly 5Fu and oxaliplatin
  • Perioperative mFLOT
  • Perioperative FOLFOX

Treatment groups

900 Participants
are divided into 3 treatment groups

Locations

This trial has no locations