Perioperative Combination Chemotherapy Versus Chemoradiation for Locally Advanced EGJ Adenocarcinoma

• Status: Not yet recruiting
• Trial end date: 2029-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
• Treatments: Oxaliplatin

Criteria

Inclusion Criteria:

• 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

• no prior other chemotherapy and/or radiation against the disease

• normal function of all other vital organs including heart,liver ,kidney and so on

• Eastern Cooperative Oncology Group performance status: 0~2

Exclusion Criteria:

• history of other malignancy

• allergic reaction to capecitabine or oxaliplatin

• enrolled in other clinical trials

• abnormal GI tract function

• dysfunction of other organs

• pregnant or lactating females ,or refuse to receive contraception measures during chemotherapy

• other situations judged as not adaptive to the study by investigators