Randomized Multicenter Phase II Trial of Capecitabine Versus S-1 as First-line Treatment in Elderly Patients With Advanced or Recurrent Unresectable Gastric Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 9
- 主要终点
- Response Rate
研究概览
简要总结
A significant proportion of advanced gastric cancer (AGC) occurs in individuals 65 years of age and older. In addition, patient delay in seeking care for symptoms results in diagnosis at a more advanced stage than that seen in younger individuals. However, clinical trials on gastric cancer rarely have been available to the elderly. Recently oral 5-FU pro-drugs, which have been reported to have clinically significant response rates and survival with mild or negligible toxicities, have been widely used for the patients with AGC. However, few studies have been conducted in elderly patients.
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 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically proven gastric or gastroesophageal junction adenocarcinoma
- •Metastatic or recurrent unresectable disease
- •Measurable lesions (according to Response Evaluation Criteria in Solid Tumors [RECIST])
- •Age: 65-85 years old
- •Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2
- •Adequate bone marrow function: absolute neutrophile counts(ANC) ≥ 1,500/ul, platelet count ≥ 100,000/ul, hemoglobin ≥ 9 g/dl)
- •Adequate renal function (serum creatinine≤ 1.5)
- •Adequate liver function (serum bilirubin ≤ 2 x upper limits of normal [UNL], aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x UNL)
- •No prior chemotherapy (but adjuvant chemotherapy completed at least 1 year prior to study treatment is allowed with the exception of capecitabine or S-1) Written informed consent was signed by the patient
排除标准
- •Previous palliative chemotherapy
- •Known allergy to study drugs
- •CNS metastasis
- •Significant medical comorbidities
- •Active ongoing infection which antibiotic treatment is needed.
- •Previous ( within 5 years) history of other malignancy except cured non-malignant skin cancer and uterine cervical cancer in situ.
研究组 & 干预措施
S-1
干预措施: S-1 (Drug)
Capecitabine
干预措施: Capecitabine (Drug)
结局指标
主要结局
Response Rate
时间窗: Up to 2 years
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progressive disease (PD), \>20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), Insufficient change to qualify for PR or PD Response rate is defined as the proportion of patients who showed OR.
次要结局
- Number of Patients With Adverse Events(Up to 2 years)
研究者
Yoon-Koo Kang
Professor
Asan Medical Center