NCT00463515已完成2 期
A Multicenter Phase II Study of Carboplatin Plus Gemcitabine Followed by Concomitant Chemoradiation in Patients With Non-resectable Stage III Non-Small-Cell-Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 4
- 主要终点
- 2-year survival rates
研究概览
简要总结
The aim of this study is to evaluate whether by combining a carboplatin-gemcitabine based induction chemotherapy with weekly cisplatin during standard thoracic radiotherapy it is possible to obtain optimal efficacy with minimal toxicity. Patients will be treated with 3 cycles of induction chemotherapy, unless there is the occurrence of early intrathoracic progression of disease. The induction chemotherapy is then to be followed by chemo-radiotherapy.
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
- •cytological or histologically 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 chemotherapy for NSCLC
- •distant metastasis or a pleural or pericardial effusion
- •treatment for malignant disease in the past or serious concomitant medical or psychiatric disease
- •active uncontrolled infection at time of inclusion
- •interstitial lung disease
- •auto-immune systemic disease with potential involvement of the lungs
- •concomitant use of amiodarone
结局指标
主要结局
2-year survival rates
次要结局
- Response rate
- Time to intrathoracic failure
- Overall survival
- Toxicity of induction chemotherapy
- Toxicity of chemo-radiotherapy
研究者
研究点 (4)
Loading locations...
相似试验
Unknown
2 期
Study of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Lung CancerNon-Small Cell Lung CancerNCT00150657St. John Providence Health System45
已完成
2 期
Carboplatin and Gemcitabine With Bevacizumab Every 2 Weeks for Stage IIIb/IV Non-small Cell Lung CancerCarcinoma, Non-Small-Cell LungNCT00400803Masonic Cancer Center, University of Minnesota38
已完成
1 期
Carboplatin Plus Gemcitabine for Elderly Patients With Stage IV NSCLCNSCLCNCT02175381Hellenic Oncology Research Group69
已完成
2 期
Combination of Gemcitabine and Carboplatin in Metastatic or Recurrent Nasopharyngeal CarcinomaNasopharyngeal CarcinomaNCT00697905Ministry of Health, Malaysia18
撤回
2 期
A Study of Gemcitabine-Carboplatin Plus Necitumumab (LY3012211) in Chemotherapy-Naïve Participants With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)Locally Advanced Squamous Non-Small Cell Lung CancerMetastatic Squamous Non-Small Cell Lung CancerNCT02941601Eli Lilly and Company