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
试验速览
- 阶段
- 3 期
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- 3-year disease-free survival
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≦
- •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
排除标准
- •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
研究组 & 干预措施
POF
A 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and leucovorin (400 mg/m2), administered simultaneously over a 2-hour infusion period. Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating every 14 days for 12 cycles.
干预措施: POF (Drug)
CAPOX/SOX/FOLFOX
CAPOX: IV oxaliplatin given over 120 min at a dose of 130 mg/m2 on day 1, oral capecitabine 1000 mg/m2 twice daily on days 1 through 14 every 21 days for 8 cycles.
SOX: Oxaliplatin 130mg/m2 IV on D1 every 21 days and S-1 80mg/m2/day PO [BSA <1.25 40mg bid (total 80mg/day); BSA ≥1.25 - <1.5 50mg bid (total 100mg/day); BSA ≥1.5 60mg bid (total 120mg/day)], divided by two on D1-14 every 21 days for 8 cycles.
mFOLFOX6: IV oxaliplatin given over 120 min at a dose of 85 mg/m2 on day 1 followed by IV leucovorin 400 mg/m2 over 2h, IV bolus 5-Fluorouracil 400 mg/m2 and IV infusional 5-Fluorouracil 2400 mg/m2 over 46h every 14 days for 12 cycles.
干预措施: CAPOX/SOX/FOLFOX (Drug)
结局指标
主要结局
3-year disease-free survival
时间窗: From enrollment to 5 years after treatment
The time from randomisation to the time of recurrence of the original gastric cancer, development of a new gastric cancer, or death from any cause
次要结局
- overall survival(From enrollment to 5 years after treatment)
- safety (The incidence of chemotherapy related adverse events)(From enrollment to 1 years after treatment)