A Prospective Phase II Study of Attenuated S-1 and Oxaliplatin(Attenuated SOX) as First-line Treatment in Elderly Patients With Relapsed or Metastatic Gastric Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 36
- 主要终点
- To evaluate response rate of attenuated SOX as first-line chemotherapy in elderly patients with relapsed or metastatic AGC
研究概览
简要总结
Stomach cancer is the most common malignant disease and the second most common cause of cancer-related deaths in the Korea. The elderly are primarily affected by the disease with most gastric cancer-related deaths occuring in patients aged 65 years or older. Systemic chemotherapy improves the quantity and quality of life in patients with gastric cancer when compared with best supportive care. However, elderly cancer patients often present with concomitant co-morbidities and age-associated physiologic problems that make the selection of optimal treatment difficult. There is also uncertainty about the use of systemic palliative chemotherapy in elderly patients because of under representation of this age group in clinical trials. Therefore, this phase II trial was planned to investigate efficacy and toxicities of combination chemotherapy with attenuated dose of S-1 and oxaliplatin (attenuated SOX)in patients with elderly AGC
详细描述
Treatment scheme
- S-1 60mg/m2/day (D1-14) Oxaliplatin: 85mg/m2 + 5DW 250mL MIV over 2-hours
Each cycle is repeated every 3 weeks
Response evaluation will be performed every 2 cycles
Repeated cycles of treatment will be given for this study unless there is confirmed disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age : more than 70 to 80 and ECOG PS 0-2
- •Age : more than 65 to less than 70 and ECOG PS 2
- •Histological or pathologically confirmed adenocarinoma
- •Relapsed or metastatic adenocarcinoma of stomach
- •No previous chemotherapy except adjuvant chemotherapy completed at least 12 months before enrollment
- •At least more than one measurable lesion on RECIST criteria
- •No radiation history for the target lesion
- •An estimated life expectancy of more than 3 months
- •Ability for adequate oral intake
- •Adequate BM function: defined as WBC≥4000/μL, ANC ≥1500/μL, PLT≥100,000/μL.
- •Adequate renal function: defined as Creatinine <1.5mg/dL.
- •Adequate hepatic function: defined as total bilirubin < 2.0mg/dL, SGOT/SGPT < normal x
- •Written informed consent
排除标准
- •Symptomatic brain metastasis or meningeal metastasis.
- •Double primary cancer
- •Medical history of other cancer within 5 years
- •G-I bleeding or intestinal obstruction (other condition that can't have the oral intake)
- •Hypersensitivity to the 5-FU or oxaliplatin
- •Active infectious disease that need to treat systemically
- •Serious medical or psychologic condition: newly developed AMI ( within 6Ms)…
结局指标
主要结局
To evaluate response rate of attenuated SOX as first-line chemotherapy in elderly patients with relapsed or metastatic AGC
时间窗: every 2 cycles
次要结局
- To evaluate progression free survival, overall survival, and toxicities of aSOX-regimen(every 2 months)