Multicenter Phase II Trial Evaluating Cisplatin-Gemcitabine With Concomitant Thoracic Radiotherapy for Treatment of Inoperable Stage III Non Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Tumor Response at End of Treatment
研究概览
简要总结
The purpose of the study is to evaluate the response rate of patients with non small lung cancer to gemcitabine in combination with radiotherapy. The tolerability and safety of this combination will also be evaluated.
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
- •Inoperable non small cell lung cancer Stage III
- •Adequate hematological parameters
- •Adequate Lung function reserve
排除标准
- •Previous chemotherapy and thoracic radiation for non small cell lung cancer
- •Presence of distant metastases
研究组 & 干预措施
Gemcitabine + Cisplatin
Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).
Cisplatin: 80 mg/m2, IV, every 21 days x 5 cycles.
Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5.
干预措施: gemcitabine (Drug)
Gemcitabine + Cisplatin
Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).
Cisplatin: 80 mg/m2, IV, every 21 days x 5 cycles.
Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5.
干预措施: cisplatin (Drug)
Gemcitabine + Cisplatin
Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).
Cisplatin: 80 mg/m2, IV, every 21 days x 5 cycles.
Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5.
干预措施: radiation (Radiation)
结局指标
主要结局
Tumor Response at End of Treatment
时间窗: baseline to first follow-up visit (up to 8 weeks after end of chemo-radiation)
Response recorded at the first follow-up visit 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; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
次要结局
- Time to Progressive Disease(Preliminary: baseline to measured progressive disease (up to 3.5 years); Final: baseline to measured progressive disease (up to 5 years);)
- Overall Survival(Preliminary: baseline to date of death from any cause (up to 3.5 years); Final: baseline to date of death from any cause (up to 5 years))
- Safety of Induction Chemotherapy(every cycle (21 days) for 3 cycles (up to 10 weeks))
- Safety of Chemo-radiotherapy(Cycles 4 and 5 up to 8 weeks after the end of chemo-radiotherapy)