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

Dragon III- Phase 2: The Preliminary Efficacy Study of FLOT Versus SOX Regimen as Neoadjuvant Chemotherapy for Patients With Locally Advanced Gastric Cancer: Open-label, Randomized Controlled Trial

Safety and efficacy study of neoadjuvant chemotherapy (FLOT versus SOX) for gastric cancer patients in high volume center of China

DRAGON III research, Neoadjuvant Chemotherapy (FLOT versus SOX) for Gastric Cancer, is an investigator initiated; phase II, open label, randomised controlled study. This study will be conducted and analyzed by the Gastrointestinal department（Unit III）of the Ruijin Hospital and the project is supported by the Institute of Digestive Surgery, Shanghai, which is a state key research center. This study will be monitored by the Clinical Research Center of the Ruijin hospital (Official body which is responsible to guide and monitor all types of research at Ruijin hospital). Primary endpoint and secondary endpoint is described above. The aim of this study to obtain preliminary result and further conduct a large scale multi-center randomised controlled trial(RCT) study.

Inclusion criteria:

• Histology confirmed non-obstructive adenocarcinoma of the stomach or esophagogastric junction.
• Clinical stage: cTNM: stage III or above
• 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
• Confirmed distant metastases
• Locally advanced inoperable disease (Clinical assessment)
• Relapse of gastric cancer
• Malignant secondary disease
• Prior chemo or radiotherapy
• Inclusion in another clinical trial
• Known contraindications or hypersensitivity for planned chemotherapy