Dragon III-Phase 3: Neoadjuvant Chemotherapy (FLOT Versus SOX) for Gastric Cancer

Efficacy Study of FLOT Versus SOX Regimen as Neoadjuvant Chemotherapy for Patients With Locally Advanced Gastric Cancer: A Phase 3 Multi-center Randomized Controlled Trial

DRAGON III research, Neoadjuvant Chemotherapy (FLOT versus SOX) for Gastric Cancer, is an investigator initiated; phase 3, open label, multi-center randomized controlled study.

Non inferiority of SOX will be tested against FLOT. This study will be conducted at multiple center of China and will invite international centers to join it.The sponsor of this study is Ruijin Hospital and the project is supported by the Shanghai Key Laboratory of Gastric Neoplasms and Institute of Digestive Surgery, Shanghai.

Inclusion Criteria:

• Histology confirmed non-obstructive adenocarcinoma of stomach or esophago-gastric junction.
• Clinical stage: Clinical Tumor-Node-Metastasis (cTNM:) stage III
• Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2 (normal to symptomatic but in bed less than half the day)
• Clinically fit for systemic chemotherapy and gastric cancer surgery, i.e. adequate renal, hepatic, hematologic and pulmonary function.
• Written informed consent

Exclusion Criteria:

• Clinically unfit for systemic chemotherapy and gastric cancer surgery, i.e. uncontrolled cardiac disease, or other clinically significant uncontrolled comorbidities, unable to undergo general anesthesia
• Distant metastases (including retroperitoneal lymph node)
• Locally advanced inoperable disease (Clinical assessment)
• Relapse of gastric cancer
• Malignant secondary disease
• Prior chemo or radio therapy
• Inclusion in another clinical trial
• Known contraindications or hypersensitivity for planned chemotherapy