A Randomized, Parallel Control Trial to Compare mFOLFOX Versus mFOLFIRI Versus FOLFPTX (a Combination of Paclitaxel, Fluorouracil) as First-line Treatment in Advanced Gastric Cancer or Adenocarcinoma of Esophagogastric Junction
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
The aim of this study was to compare the efficacy and safety of mFOLFOX, mFOLFIRI and FOLFPTX as first-line treatment in AGC or EGJA.
详细描述
In previous studies, we found that mFOLFOX(a Combination of Oxaliplatin, Fluorouracil), mFOLFIRI(a Combination of Irinotecan, Fluorouracil), FOLFPTX (a Combination of Paclitaxel, Fluorouracil) are active in patients with AGC or EGJA.This study is being done to find out which one has the best efficacy.
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：18~70years.
- •Subjects with Histologically or cytologically confirmed advanced or metastatic gastric cancer or adenocarcinoma of gastroesophageal junction.
- •First-line treatment patients.
- •subjects with at least one measurable lesion as defined by RECIST (version 1.1).
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Survival expectation≥ 3 months.
- •No serious concomitant diseases(including heart,lung,liver jaundice or gastrointestinal obstruction and so on ).
- •Adequate organ functions defined as indicated below： （1）Adequate bone marrow function, defined as: (no blood transfusion within 14 days)
- •Hemoglobin (Hb)≥80g/L，
- •White blood count (WBC)≥3.5×109/L
- •Absolute neutrophil count (ANC)≥1.5×109/L，
- •Platelet count (PLT)≥75×109/L； （2）Adequate liver function, defined as:
- •Bilirubin ≤1.5×the upper limit of normal (ULN)
- •Alanine aminotransferase (ALT), or Aspartate aminotransferase (AST) ≤3.0×(ULN), Glutamyl transpeptidase(GGT)≤2.5×(ULN), (When liver metastases, ALT or AST and GPT <5.0×(ULN)).
- •serum creatinine ≤1.0×（ULN）, or creatinine clearance > 50 mL/min( calculated per the Cockcroft and Gault formula)
- •Females of childbearing potential must be a pregnancy test in 7 days before participating ( including serum or urine), and the results were negative, Females of childbearing potential must agree to use a highly effective method of contraception throughout the entire study period and for 8 weeks after study drug discontinuation. Male subjects must have had a successful vasectomy or they and their female partners must meet the criteria above (i.e.not of childbearing potential or practicing highly effective contraception throughout the study period and for 8 weeks after study drug discontinuation).
- •Subjects provided written informed consent before participating,Willing and able to comply with all aspects of the protocol.
排除标准
- •Females are lactating or pregnant at Screening or Baseline.
- •Patients with other active malignancy (except for definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix).
- •Patients who have received previous pre- or post-operative chemotherapy or chemoradiation are ineligible if therapy was completed less than 6 months prior to study registration. Patients must have recovered from adverse events from any previous therapy.
- •Patients with brain or central nervous system metastases, including leptomeningeal disease.
- •Significant cardiac disease as defined as:unstable angina, New York Heart Association (NYHA) grade II or greater, congestive heart failure, history of myocardial infarction within 6 months Evidence of bleeding diathesis or coagulopathy.
- •History of a stroke or CVA within 6 months.
- •Inability to comply with study and/or follow-up procedures.
- •Patients with any other condition that in the opinion of the investigator would preclude his/her participation in a clinical study.
研究组 & 干预措施
mFOLFOX
The mFOLFOX regimen consisted of oxaliplatin (85 mg/m2) and calcium levofolinate (200 mg/m2).Subsequently, a 48-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days till progressive disease or intolerable toxicities.
干预措施: Fluorouracil (Drug)
mFOLFOX
The mFOLFOX regimen consisted of oxaliplatin (85 mg/m2) and calcium levofolinate (200 mg/m2).Subsequently, a 48-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days till progressive disease or intolerable toxicities.
干预措施: Oxaliplatin (Drug)
mFOLFOX
The mFOLFOX regimen consisted of oxaliplatin (85 mg/m2) and calcium levofolinate (200 mg/m2).Subsequently, a 48-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days till progressive disease or intolerable toxicities.
干预措施: calcium levofolinate (Drug)
mFOLFIRI
The mFOLFIRI regimen consisted of irinotecan (180 mg/m2) and calcium levofolinate (200 mg/m2).Subsequently, a 48-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days till progressive disease or intolerable toxicities.
干预措施: Fluorouracil (Drug)
mFOLFIRI
The mFOLFIRI regimen consisted of irinotecan (180 mg/m2) and calcium levofolinate (200 mg/m2).Subsequently, a 48-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days till progressive disease or intolerable toxicities.
干预措施: Irinotecan (Drug)
mFOLFIRI
The mFOLFIRI regimen consisted of irinotecan (180 mg/m2) and calcium levofolinate (200 mg/m2).Subsequently, a 48-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days till progressive disease or intolerable toxicities.
干预措施: calcium levofolinate (Drug)
FOLFPTX
The FOLFPTX regimen consisted of paclitaxel (95 mg/m2) and calcium levofolinate (200 mg/m2).Subsequently, a 48-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days till progressive disease or intolerable toxicities.
干预措施: Fluorouracil (Drug)
FOLFPTX
The FOLFPTX regimen consisted of paclitaxel (95 mg/m2) and calcium levofolinate (200 mg/m2).Subsequently, a 48-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days till progressive disease or intolerable toxicities.
干预措施: Paclitaxel (Drug)
FOLFPTX
The FOLFPTX regimen consisted of paclitaxel (95 mg/m2) and calcium levofolinate (200 mg/m2).Subsequently, a 48-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days till progressive disease or intolerable toxicities.
干预措施: calcium levofolinate (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: 24 months
Adverse Event（AE）
时间窗: 35 months
NCI CTC 4.03
次要结局
- Disease Control Rate (DCR)(24 months)
- Overall Survival (OS)(35 months)
- Objective Response Rate (ORR)(24 months)
- Quality of Life (QoL)(35 months)