Gastric Cancer Clinical Trial
Official title:
An Randomized, Multicenter, Open-label, Phase III Trial Comparing Neoadjuvant Chemoradiotherapy Versus Chemotherapy in Patients With Locally Advanced Gastric Adenocarcinoma
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.
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 ā‰¤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.
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