Phase II Study of Concurrent Carboplatin, Pemetrexed, and Radiotherapy for Limited Stage of Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Proportion of Patients With a Complete or Partial Response (Overall Response Rate [ORR])
研究概览
简要总结
This is a multicenter, phase II, open-label trial to evaluate the efficacy of pemetrexed + carboplatin combined with thoracic radiotherapy in patients with Limited Stage of small cell lung cancer
详细描述
Two 21-day cycles of pemetrexed (500 milligrams per square meter [mg/m2] intravenous [IV] infusion) and carboplatin (target area under the curve [AUC] 5 IV infusion) followed by two 21-day cycles of pemetrexed (500 mg/m2 IV infusion) and carboplatin (target AUC 5 IV infusion) with concurrent radiotherapy (2 Gray [Gy] per fraction, 5 fractions per week, up to a dose of 50 Gy is administered).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic and/or cytologic diagnosis of Limited Stage of small cell lung cancer
- •Measurable disease
- •Good performance status
- •Adequate bone marrow reserve, hepatic, pulmonary and renal functions
排除标准
- •Serious concomitant systemic disorder
- •Prior chemotherapy for this cancer and/or prior thoracic radiotherapy
- •Pregnancy/breast-feeding
- •Significant weight loss over the previous 6 weeks before study entry
- •Inability or unwillingness to take vitamin supplementation and corticosteroids
研究组 & 干预措施
Pemetrexed + Carboplatin
干预措施: pemetrexed (Drug)
Pemetrexed + Carboplatin
干预措施: carboplatin (Drug)
Pemetrexed + Carboplatin
干预措施: radiotherapy (Procedure)
结局指标
主要结局
Proportion of Patients With a Complete or Partial Response (Overall Response Rate [ORR])
时间窗: baseline to measured response after chemotherapy and radiation
Overall Response Rate (ORR) was defined as the proportion of participants having either a Complete or Partial response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions.
次要结局
- Progression-free Survival(baseline to measured progressive disease)
- Overall Survival(baseline to date of death from any cause, 1 year)
- Duration of Response(time of response to progressive disease)
- Pharmacology Toxicity(every 21-day cycle for 4 cycles)