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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
246
Perioperative chemotherapy will be administered according to description in two arms.
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Total Percentage of Patients With Pathological Complete Tumor Regression (TRG1a) and Sub-total Tumor Regression (TRG1b) in the Primary Tumour
Tumor regression grade (TRG), Becker criteria Grade 1a :Complete tumor regression: 0% residual tumor per tumor bed Grade 1b: Subtotal tumor regression: \<10% residual tumor per tumor bed Grade 2: Partial tumor regression: 10-50% residual tumor per tumor bed Grade 3: Minimal or no tumor regression: \>50% residual tumor per tumor bed
Time frame: Upto three months
Overall Survival (OS)
Overall survival Time from randomization to death from any cause
Time frame: Five years
Disease free survival (DFS)
Disease free survival Time from randomization to relapse or death from any cause
Time frame: Three years
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