A Randomized Phase III Study Comparing POF With SOX/CAPOX/FOLFOX as a Postoperative Adjuvant Chemotherapy for Curatively Resected Stage III Gastric Cancer

A Randomized Phase III Study Comparing POF (Paclitaxel/Oxaliplatin/Leucovorin/5-FU) With SOX/CAPOX/FOLFOX as a Postoperative Adjuvant Chemotherapy for Curatively Resected Stage III Gastric Cancer

FNF-014 is a randomised, open-label, multicentre, parallel-group, phase 3 study in China to prove superiority of POF over S-1/docetaxel in postoperative adjuvant setting for pStage III gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction).

Inclusion Criteria:

• Age 18 to 70 years.
• Histologically proven in gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) of stage IIIA, IIIB, IIIC with no evidence of metastatic disease.
• Subjects must be able to take orally.
• R0 resection with D2 lymph-node dissection with al least 15 lymph nodes were examined to ensure adequate disease classification.
• Previously untreated except for the initial gastric resection for the primary lesion.
• ECOG performance status ≦ 1.
• Able to start chemotherapy with 42 days after gastrectomy.
• Hgb ≧ 9 g/dL, WBC 4000-12000/mm3, platelets ≧ 100,000/mm3
• Creatine ≦ upper normal limit (UNL)
• Total bilirubin ≦ 1.5 X UNL
• AST, ALT and ALP ≦ 2.5 x UNL
• Life expectancy estimated than 3 months
• Written informed consent

Exclusion Criteria:

• Active double cancer
• Gastrointestinal bleeding
• Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant
• Definite contraindications for the use of corticosteroids
• Any subject judged by the investigator to be unfit for any reason to participate in the study