A Randomized Single Center Phase II Study Comparing XELOX With Capecitabine Maintenance or XELOX Treatment in Elderly Metastatic Adenocarcinoma of Stomach
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
To confirm the efficacy and safety of XELOX with capecitabine maintenance in treatment of elderly advanced gastric cancer (AGC) by comparing it with that of XELOX regimen.
详细描述
To investigate whether XELOX with capecitabine maintenance treatment as 1st line treatment in the elderly advanced gastric cancer is as effective and safe as XELOX regimen.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages Eligible for Study: 65 Years or older
- •Genders Eligible for Study: Both
- •The Eastern Cooperative Oncology Group (ECOG) status ≤ 2
- •Histologically confirmed gastric adenocarcinoma(including LAUREN type).
- •Measurable disease(according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1).
- •chemotherapy naive after recurrence or metastasis. Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months.
- •Hb > 90g/L, neutrophil count > or = 1.5*10^9/L, platelet > or = 100*10^9/L, alanine transaminase (ALT) and aspartate aminotransferase (AST) < or = 2.5 times upper limit of nominal (ULN), alkaline phosphatase (ALP) < or = 2.5 times ULN, total bilirubin (TBIL) < 1.5 times ULN, serum albumin level > or = 30g/L, serum creatinine < 1 times ULN.
- •No serious concomitant diseases which could lead to death within 5 years. At least 5 years from the last Biological/Immunotherapy/Hormone treatment for Malignancy excluding gastric cancer.
- •Able to accept oral medication
- •Compliance with protocol
排除标准
- •Had received cytotoxic chemotherapy, radiotherapy or immunotherapy for this gastric cancer, excluding Corticosteroids.
- •Other previous malignancy within 5 year, except curative skin cancer or carcinoma in situ of uterine cervix.
- •Uncontrolled epilepsy, central nervous system disorders, or a history of mental disorders.
- •clinically significant(i.e. active)cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) II or more serious congestive heart failure or severe requiring medication intervention arrhythmia, or history of myocardial infarction within the last 12 months.
- •Upper gastrointestinal obstruction or physiological dysfunction or suffering from malabsorption syndrome, which could affect the absorption of capecitabine.
- •Organ transplantation requires immunosuppressive treatment.
- •Severe uncontrolled recurrent infections, or Other serious uncontrolled concomitant diseases.
- •Moderate or severe renal impairment(creatinine clearance (CCr) = or < 50 ml/min), or serum creatinine > ULN.
- •Known enzyme deficiency of dihydropyrimidine dehydrogenase(DPD).
- •Allergy to Oxaliplatin or any study medication ingredients.
研究组 & 干预措施
XELOX-X
XELOX: Oxaliplatin: 100mg/m2 d1 Intravenous infusion, every 3 weeks. Capecitabine: 850mg/m^2 bid, days 1-14, every 3 weeks and maximum 4 cycles, or progression/intolerance.
X Maintenance: Capecitabine 850mg/m^2 bid, days 1-14, every 3 weeks after 4 cycles XELOX regimen, until progression/intolerance.
干预措施: Oxaliplatin (Drug)
XELOX-X
XELOX: Oxaliplatin: 100mg/m2 d1 Intravenous infusion, every 3 weeks. Capecitabine: 850mg/m^2 bid, days 1-14, every 3 weeks and maximum 4 cycles, or progression/intolerance.
X Maintenance: Capecitabine 850mg/m^2 bid, days 1-14, every 3 weeks after 4 cycles XELOX regimen, until progression/intolerance.
干预措施: Capecitabine (Drug)
XELOX
XELOX: Oxaliplatin 100mg/m2 d1 Intravenous infusion, every 3 weeks. Capecitabine 850mg/m^2 bid, days 1-14, every 3 weeks, until progression/intolerance.
干预措施: Oxaliplatin (Drug)
XELOX
XELOX: Oxaliplatin 100mg/m2 d1 Intravenous infusion, every 3 weeks. Capecitabine 850mg/m^2 bid, days 1-14, every 3 weeks, until progression/intolerance.
干预措施: Capecitabine (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
次要结局
- overall survival (OS)(from the date of randomization until death from any cause or up to 1 year)
- Response Rate (RR)(evaluate every 6 weeks after the date of randomization until diease progress or up to 12 weeks)
- adverse events (AE)(from date of randomization to 28 days after the last chemo dosage)
研究者
BAI Yuxian
Professor
Harbin Medical University