Perioperative Combination Chemotherapy Versus Chemoradiation for Locally Advanced EGJ Adenocarcinoma

Phase

Condition

Neoplasms

Adenocarcinoma

Treatment

N/A

Clinical Study ID

NCT03961841

SAHMO202

Ages 18-75
All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Study Design

June 01, 2020

August 31, 2029