A Randomized Multicenter Phase II Study Of Induction Therapy With Pemetrexed And Cisplatin Followed By Chemoradiation With Pemetrexed Versus Chemoradiation With Pemetrexed Followed By Consolidation Therapy With Pemetrexed And Cisplatin In Patients With Stage III Non-Small Cell Lung Cancer: Paccora Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Response rate
研究概览
简要总结
The aim of this study is to evaluate if the multi modality treatment pemetrexed combined with cisplatin and radiotherapy can lead to a better tumor control and/or a better side-effect profile in patients with locally advanced NSCLC. Patients will be randomized between 3 cycles of induction chemotherapy followed by concurrent chemoradiotherapy or concurrent chemoradiotherapy followed by 3 cycles of adjuvant combination chemotherapy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cytological or histological proven NSCLC
- •unresectable stage III NSCLC
- •presence of at least one measurable lesion (RECIST criteria)
- •adequate haematological, renal and hepatic function
- •adequate lung function reserve
- •good condition, weight loss <10 % over previous 6 months, life expectancy > 3 months
排除标准
- •previous chemo- or radiotherapy for NSCLC
- •distant metastasis or a malignant pleural or pericardial effusion
- •second active primary malignancy or serious concomitant medical disease
- •interstitial lung disease
- •auto-immune systemic disease with potential involvement of the lungs
- •inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period
- •concomitant use of amiodarone
研究组 & 干预措施
A
pemetrexed + cisplatin (3 cycles) followed by thoracic irradiation + pemetrexed
干预措施: combination chemotherapy (pemetrexed + cisplatin) (Drug)
A
pemetrexed + cisplatin (3 cycles) followed by thoracic irradiation + pemetrexed
干预措施: thoracic irradiation + pemetrexed (Radiation)
B
thoracic irradiation + pemetrexed followed by pemetrexed + cisplatin
干预措施: combination chemotherapy (pemetrexed + cisplatin) (Drug)
B
thoracic irradiation + pemetrexed followed by pemetrexed + cisplatin
干预措施: thoracic irradiation + pemetrexed (Radiation)
结局指标
主要结局
Response rate
时间窗: after each treatment modality and 5 year follow-up
次要结局
- Toxicity(at the end of each cycle and 5 year follow-up)
- Time to progression(5 year follow-up)
- Overall survival(median survival and 2-year survival)