Spots Global Cancer Trial Database for Neoadjuvant Chemoradiotherapy vs. Chemotherapy With Radical Gastrectomy and Adjuvant Chemotherapy for Advanced Gastric Cancer

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Trial Identification

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

Official Title: An Randomized, Multicenter, Open-label, Phase III Trial Comparing Neoadjuvant Chemoradiotherapy Versus Chemotherapy in Patients With Locally Advanced Gastric Adenocarcinoma

Study ID: NCT01815853

Conditions

Gastric Cancer

Interventions

Neoadjuvant Chemoradiotherapy

Neoadjuvant Chemotherapy

R0 D2 Gastrectomy

Adjuvant Chemotherapy

Study Description

Brief 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.

Detailed 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.