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

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 3-year disease free survival (DFS), and secondary end point is 5-year overall survival (OS), R0 resection rate, pathological complete remission (pCR) and treatment safety.

Conditions

• Gastric Cancer

Interventions

RADIATION

Neoadjuvant Chemoradiotherapy

Radiotherapy (45Gy/25f) + 3 cycles of XELOX Chemotherapy \[Oxaliplatin 130 mg/m² IV on Day 1 + Capecitabine 1000 mg/m² orally BID on Days 1-14 of a 21-day cycle (non-concurrent); Oxaliplatin 100 mg/m² IV on Day 1 + Capecitabine 825 mg/m² orally BID on Days 1-14 of a 21-day cycle (concurrent chemoradiotherapy)\]

DRUG

Neoadjuvant Chemotherapy

3 cycles of XELOX Chemotherapy (Oxaliplatin 130 mg/m² IV on Day 1 + Capecitabine 1000 mg/m² orally BID on Days 1-14 of a 21-day cycle)

PROCEDURE

R0 D2 Gastrectomy

DRUG

Adjuvant Chemotherapy

3 cycles of XELOX Chemotherapy (Oxaliplatin 130 mg/m² IV on Day 1 + Capecitabine 1000 mg/m² orally BID on Days 1-14 of a 21-day cycle)

Sponsors & Collaborators

• The First Affiliated Hospital of Anhui Medical University

  collaborator OTHER

• Liaoning Cancer Hospital & Institute

  collaborator OTHER

• Guangdong Provincial Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Tianjin Medical University Cancer Institute and Hospital

  collaborator OTHER

• Zhejiang Cancer Hospital

  collaborator OTHER

• First Hospital of China Medical University

  collaborator OTHER

• The Affiliated Tumor Hospital of Guangxi Medical University

  collaborator UNKNOWN

• Hangzhou First People's Hospital, School of Medicine, Zhejiang Universiry

  collaborator UNKNOWN

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

• Sichuan Cancer Hospital and Research Institute

  collaborator OTHER

• National Clinical Research Center for Cancer/Cancer Hospital

  collaborator UNKNOWN

• Sun Yat-sen University

  lead OTHER

Principal Investigators

• Zhi-wei Zhou, M.D, Ph.D · Sun Yat-sen University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-06-30

Primary Completion

2025-06-30

Completion

2025-06-30

Countries

• China

Study Locations