Phase II Study Evaluating the Interest of the Re-introduction of Pemetrexed and Platinum (Cisplatin or Carboplatin) With Prolonged Angiogenic Blocking by Bevacizumab in Non Squamous Non Small Cell Lung Cancer of Advanced Stage.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 12
- 主要终点
- Feasibility
研究概览
简要总结
At present, the treatment of non-squamous cell lung cancer is based on chemotherapy with platinum eventually associated with bevacizumab. A new treatment begins at progression.
In colo-rectal metastatic cancer, it was demonstrated that the first-line of treatment could be administered according to a stop and go strategy respecting therapeutic breaks between sequences of identical treatment. During these therapeutic breaks, a treatment of maintenance is possibly better than an absence of treatment. These plans benefit to the patients in terms of efficiency but also in terms of toxicity, in particular neurological.
The question is to know if this strategy is feasible in lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Non squamous non small cell lung cancer histologically or cytologically confirmed with no EGFR mutation.
- •Stage IV NSCLC. Patient with cerebral metastasis are eligible if the metastasis is asymptomatic.
- •Measurable disease (recist criteria)
- •Age ≥18 years
排除标准
- •Mixed cancer small cells and non small cells or squamous lung cancer . EGFR mutated cancer
- •History of malignant tumour excepted cervical and basocellular cancer and cancer cured for at least 5 years.
- •Tumor invaded the big vessels or the proximal visible in TDM.
- •History of adjuvant or neoadjuvant chemotherapy
研究组 & 干预措施
BUCiL
Sequence 1 : 3 cycles of cisplatin-pemetrexed-bevacizumab, then maintenance by bevacizumab if disease control. If progression --> Sequence 2
Sequence 2 : 3 cycles of cisplatin-pemetrexed-bevacizumab, then maintenance by bevacizumab-pemetrexed if disease control
干预措施: Cisplatin (Drug)
BUCiL
Sequence 1 : 3 cycles of cisplatin-pemetrexed-bevacizumab, then maintenance by bevacizumab if disease control. If progression --> Sequence 2
Sequence 2 : 3 cycles of cisplatin-pemetrexed-bevacizumab, then maintenance by bevacizumab-pemetrexed if disease control
干预措施: Bevacizumab (Drug)
BUCiL
Sequence 1 : 3 cycles of cisplatin-pemetrexed-bevacizumab, then maintenance by bevacizumab if disease control. If progression --> Sequence 2
Sequence 2 : 3 cycles of cisplatin-pemetrexed-bevacizumab, then maintenance by bevacizumab-pemetrexed if disease control
干预措施: Pemetrexed (Drug)
结局指标
主要结局
Feasibility
时间窗: After 3 cycles
Number of patients receiving 3 cycles of chemotherapy with full-dose platinum in the 2nd sequence
次要结局
- Control rate after the 2nd sequence(After 3 cycles)
- Response rate after the 1st sequence(After 3 cycles)
- Overall survival(12 months)
- Quality of life(During Sequence 2 : at the beginning and after 3 cycles)