Irinotecan Plus Oxaliplatin, 5-fluorouracil and Leucovorin as First-line Treatment for Metastatic Gastric Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 388
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This parallel, randomized, open-label study will evaluate the effect on overall survival of irinotecan on oxaliplatin and 5-fluorouracil (5-FU) in patients with HER2-negative and pMMR metastatic gastric cancer. Irinotecan will be administered as intravenous infusion of 150 mg/m2 every 2 weeks. Oxaliplatin will be given 85 mg/m2 and 5-FU will be given 400mg/m2 iv and 2400mg/m2 civ 48 hours fortnightly. Treatment will continue until disease progress or untolerable toxicity appears. The target sample size is 350-400 patients.
详细描述
Eligible patients will be randomly assigned to FOLFOXiri group and FOLFOX group. Stratification factors include ECOG PS, disease extent and pathological subtypes. Efficacy will be evaluated every 3-4 cycles with RECIST. Toxicity will be assessed with WHO CTC 3.0 every 2 weeks.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years old, gender is not limited;
- •Inoperable locally advanced, recurrent, and/or metastatic cancer of the stomach or gastro-esophageal junction;
- •Pathologically confirmed adenocarcinoma;
- •Expected survival time ≥ 3 months;
- •ECOG PS 0-3;
- •Adequate bone marrow function reserve: white blood cell count ≥ 3.0 × 10*9 / L, neutrophil count ≥ 1.5 × 10*9/ L; platelet count ≥ 100 ×10*9/ L; hemoglobin ≥ 90 g / L;
- •AST and ALT ≤ 2.5 times the upper limit of normal value, total bilirubin ≤ 2 times the upper limit of normal value; serum creatinine ≤ 1.5 times the upper limit of normal value;
- •Be able to understand the research process, volunteer to participate in the study, and sign an informed consent form.
排除标准
- •Patients known to be allergic to active or other components of chemotherapeutic drugs;
- •Patients with severe peritoneal dissemination and GI obstruction;
- •Her-2 overexprssion or d-MMR;
- •Severe or uncontrolled infections that may affect the evaluation of the study treatment or study results;
- •History of other malignant tumors in the past 5 years (except for cured cervical carcinoma in situ or basal cell carcinoma of the skin);
- •Participated in other clinical trials within 4 weeks prior to the start of the study;
- •Pregnant or lactating women, or women of childbearing age who refuse to take effective contraception during the study period.
研究组 & 干预措施
FOLFOXiri group
Irinotecan 150 mg/m2 iv drip d1; Oxaliplatin 85 mg/m2 iv drip d1; LV 200 mg/m2 iv drip d1; 5FU 400mg/m2 iv bolus and 2400 mg/m2 civ; The regimen will be repeated every 2 weeks until disease progression or untolerable toxicity.
干预措施: 5-fluorouracil (Drug)
FOLFOX group
Oxaliplatin: 85 mg/m2 iv drip d1; LV 200 mg/m2 iv drip d1; 5FU 400mg/m2 iv bolus and 2400 mg/m2 civ 46h; The regimen will be repeated every 2 weeks until disease progression or untolerable toxicity.
干预措施: Oxaliplatin (Drug)
FOLFOXiri group
Irinotecan 150 mg/m2 iv drip d1; Oxaliplatin 85 mg/m2 iv drip d1; LV 200 mg/m2 iv drip d1; 5FU 400mg/m2 iv bolus and 2400 mg/m2 civ; The regimen will be repeated every 2 weeks until disease progression or untolerable toxicity.
干预措施: Irinotecan (Drug)
FOLFOXiri group
Irinotecan 150 mg/m2 iv drip d1; Oxaliplatin 85 mg/m2 iv drip d1; LV 200 mg/m2 iv drip d1; 5FU 400mg/m2 iv bolus and 2400 mg/m2 civ; The regimen will be repeated every 2 weeks until disease progression or untolerable toxicity.
干预措施: Oxaliplatin (Drug)
FOLFOX group
Oxaliplatin: 85 mg/m2 iv drip d1; LV 200 mg/m2 iv drip d1; 5FU 400mg/m2 iv bolus and 2400 mg/m2 civ 46h; The regimen will be repeated every 2 weeks until disease progression or untolerable toxicity.
干预措施: 5-fluorouracil (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: 2 years
OS is defined as the time from the date of randomization to the date of death due to any cause. Participants were censored at the last date of tumor measurement, the last date in the study drug log or the date of last follow-up.
次要结局
- Progression-Free Survival (PFS)(1 year)
- Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Determined by Response Evaluation Criteria in Solid Tumors (RECIST)(24 weeks)
- Duration of Response(1 year)
- European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores(2 years)
- EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores(2 years)
- Treatment associated toxicities(2 years)
研究者
Jian Xiao
Asso. Professor
Sixth Affiliated Hospital, Sun Yat-sen University