NCT00580359Unknown2 期
A Randomized Phase II Study of S-1 Versus Capecitabine as First-Line Chemotherapy in the Elderly and/or Poor Performance Status Patients With Recurrent or Metastatic Gastric Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- To evaluate each response rate of S-1 and capecitabine in the elderly and/or poor performance status patients with recurrent or metastatic gastric cancer
研究概览
简要总结
This study is an open-label, single-center, and randomized phase II study designed to evaluate each efficacy and safety of S-1 and capecitabine in the elderly and/or poor performance status patients with recurrent or metastatic gastric cancer. The randomization will be stratified by age (70-85 years versus 65 years and < 70 years) and performance status, which is dependent on age group; in 70-85 years, ECOG performance status 0-1 versus 2 and in ³65 years and <70 years, ECOG performance status 2 versus 3.
- S-1 40mg/m2 orally twice daily on days 1 (evening) - 15 (morning)
- Capecitabine 1250mg/m2 orally twice daily on days 1 (evening) - 15 (morning) Treatment will be administered every 3 weeks and will be continued in the absence of disease progression or unacceptable toxicity.
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
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed gastric adenocarcinoma with recurrent or metastatic disease
- •Age of 70-85 years with Eastern Cooperative Oncology Group (ECOG) performance status 0-2 or age ≥65 and <70 with ECOG performance status ≥ 2
- •Measurable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) Measurable lesions:
- •Lesions that can be accurately measured in at least one dimension by any of the following:
- •Computed tomography (CT) of abdomen, pelvis or thorax, if the longest diameter to be recorded is at least 10 mm with spiral CT
- •Chest x-ray, if the lung lesion to be recorded is clearly defined and surrounded by aerated lung and the diameter to be recorded is at least 20 mm- Physical examination, if the clinically detected lesions are superficial (e.g., skin nodule and palpable lymph nodes) and at least 10 mm
- •No prior chemotherapy for recurrent and/or metastatic disease (prior adjuvant/neoadjuvant chemotherapy is allowed at least 6 months has relapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the therapy; prior S-1 or capecitabine is not allowed)
- •Adequate major organ function including the following:
- •Hematopoietic function:
- •absolute neutrophil count (ANC)≥1,500/mm3,
- •Platelet ≥ 100,000/mm3,
- •Hepatic function:
- •serum bilirubin =< 1.5 x upper limit of normal (ULN),
- •AST/ALT levels =< 2.5 x ULN ( 5 x ULN if liver metastases are present)
- •Renal function:
- •serum creatinine =< 1.5 x ULN
- •Patients should sign a written informed consent before study entry
排除标准
- •Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (e.g. patients with partial or total gastrectomy can enter the study, but not those with a jejunostomy probe), or inability to take oral medication
- •Patients with active (significant or uncontrolled) gastrointestinal bleeding
- •Inadequate cardiovascular function:
- •New York Heart Association class III or IV heart disease
- •Unstable angina or myocardial infarction within the past 6 months
- •History of significant ventricular arrhythmia requiring medication with antiarrhythmics or significant conduction system abnormality
- •Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
- •Other malignancy within the past 3 years except non-melanomatous skin cancer or carcinoma in situ of the cervix
- •History of or current brain metastases
- •Psychiatric disorder that would preclude compliance
- •Known dihydropyrimidine dehydrogenase deficiency
- •Patients receiving a concomitant treatment with drugs interacting with S-1 or capecitabine such as flucytosine, phenytoin, warfarin, lamivudine, or allopurinol et al.
- •Patients with known active infection with HIV, HBV, or HCV
- •Major surgery within 4 weeks of start of study treatment, without complete recovery
- •Radiotherapy within 4 weeks of start of study treatment; 2 weeks interval allowed if palliative radiotherapy was given to bone metastatic site and patient recovered from any acute toxicity
研究组 & 干预措施
A
Active Comparator
S-1 40mg/m2 orally twice daily on days 1 (evening) - 15 (morning)
干预措施: S-1, capecitabine (Drug)
B
Active Comparator
Capecitabine 1250mg/m2 orally twice daily on days 1 (evening) - 15 (morning)
干预措施: S-1, capecitabine (Drug)
结局指标
主要结局
To evaluate each response rate of S-1 and capecitabine in the elderly and/or poor performance status patients with recurrent or metastatic gastric cancer
时间窗: During Chemotherapy
次要结局
- the duration of response, time to progression, progression-free survival,overall survival,the safety profiles,the quality of life,the CYP2A6 genetic polymorphism and its association with clinical outcomes in patients treated with S-1(During study period)
研究者
研究点 (1)
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