Neoadjuvant Chemoradiotherapy vs. Chemotherapy With Radical Gastrectomy and Adjuvant Chemotherapy for Advanced Gastric Cancer

  • STATUS
    Recruiting
  • End date
    Dec 22, 2025
  • participants needed
    620
  • sponsor
    Sun Yat-sen University
Updated on 22 January 2021
gastrectomy
oxaliplatin
gastric adenocarcinoma
capecitabine
cancer chemotherapy
adenocarcinoma
adjuvant chemotherapy
immunostimulants
xelox regimen

Summary

Patients with histologically confirmed gastric adenocarcinoma with locally advanced gastric cancer are randomized in a 1:1 ratio to receive neoadjuvant chemoradiotherapy with DT45Gy/25f plus three cycles of XELOX therapy or neoadjuvant chemotherapy alone using XELOX regimen following D2 gastrectomy and adjuvant chemotherapy for 3 cycles. 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.

Description

Background: Literatures have shown that patitents with locally advanced gastric cancer could potentially benefit from neoadjuvant chemoradiotherapy, but whether this can improve patitents' outcome is still unclear.

Patients and methods: In this study , patients with histologically confirmed gastric adenocarcinoma with pre-operative staging are cT3N2/N3M0, cT4aN+M0 and cT4bNanyM0, 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 ratio to receive neoadjuvant chemoradiotherapy with DT45Gy/25f plus three cycles of XELOX therapy (Capecitabine 1000mg/m2, BID, D1-14; Oxaliplatin 130mg/m2 on day 1 for a 21-day cycle) or neoadjuvant chemotherapy alone using XELOX regimen following by D2 gastrectomy and adjuvant chemotherapy with same dosage of XELOX therapy for up to 3 cycles. 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.

Details
Condition Gastropathy, Stomach Discomfort, Gastric Cancer, Gastric Cancer, Stomach Cancer, Stomach Discomfort, Gastric Carcinoma, Stomach Cancer, gastric cancers
Treatment Adjuvant chemotherapy, Pre-operative chemoradiotherapy, Capecitabine,Oxaliplatin, Neoadjuvant Chemotherapy, neoadjuvant chemoradiotherapy, R0 D2 Gastrectomy
Clinical Study IdentifierNCT01815853
SponsorSun Yat-sen University
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

informed consensus of the enrolled patients
being able to receive oral drug
from 18 to 75 years old
proven to be primary adenocarcinoma of gastric cancer and pre-operative staging cT3N2/N3M0, cT4aN+M0, cT4bNanyM0
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
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