Role of 18FDG PET in the Evaluation of Early Response to Maintenance Treatment With Bevacizumab or Pemetrexed in Advanced Non-small-cell Lung Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 10
- 主要终点
- progression free survival
研究概览
简要总结
Non small cell lung cancer is the first cause of cancer related death in France and is becoming an increasing health problem in developing countries.
Recently for patient with no progression disease after first line chemotherapy, new therapies were validated in maintenance (bevacizumab) or switch maintenance treatment (erlotinib, pemetrexed) with improved survival.
Until now, determination of efficiency of treatment is only based on morphological response (RECIST) and remains inappropriate to such cytostatic drugs for which there is no anatomical lesion modification.
Nuclear Medicine and especially 18-FDG Positron Emission Tomography (PET) offers a biologically relevant tool for assessment of tumour response therapies.
The assumption of the study is that FDG PET would allow to earlier detect a lack of response, thereafter, to modify an ineffective treatment. Indeed, nowadays the treatment is maintained up to evidence of progression disease.
However, despite the increasing use of FDG PET for predicting therapeutic response, there are no validated criteria for judging response of maintenance therapy in non-small cell lung cancer.
It seems necessary to determine standardized criteria response, earlier during the course of maintenance therapy in patient with non small cell lung cancer.
The final aim is to optimize survival by an adapted metabolic imaging guided therapy.
详细描述
The purpose of the study is to optimize survival by an adapted metabolic imaging therapy in patients with advances non-small cell lung cancer.
The primary objective of the study is to evaluate the role of SUV and metabolic volume measured by FDG PETScan in the early prediction of treatment response.
80 patients will be included in 2 years. They will be follow up for one year for monitoring the progression free survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Age superior to 18 years old
- •Effective contraception method or negative pregnancy test at the inclusion
- •OMS inferior or equal to 1
- •Non-small cell lung cancer stage IIIb or IV
- •Non progressive disease after at lest 4 cycles of platinum-based chemotherapy
- •Eligible fo maintenance therapy with bevacizumab and/or pemetrexed
- •Inform consent signed
排除标准
- •Evolution of a second cancer in the 3 years before inclusion
- •Pregnancy or breast-feeding
- •poorly controlled diabetes
- •curatorship or guardianship
- •contraindication to iodinated contrast agents
- •participation to another clinical research with an experimental drug
- •impossible decubitus
- •not possibility to follow-up the procedures of the study due to geographic, social or psychic reasons
结局指标
主要结局
progression free survival
时间窗: 16 weeks after the start of maintenance therapy
time between the start of maintenance therapy and progression
次要结局
- progression free survival(on year)