Could Positon Emission Tomography With Radiolabelled 3'-Deoxy-3'-(18)F-Fluoro-L-Thymidine be a Theranostic Tool During Erlotinib Treatment in Non-small Cell Lung Cancer Patients ?
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 80
- 试验地点
- 16
- 主要终点
- Early prediction of response to erlotinib therapy by 18F-FLT and 18F-FDG PETscans
研究概览
简要总结
In France, lung cancer is the leading cause of death induced by cancer. Therapeutic advances have been made in therapy of unresectable non-small cell lung cancer (NSCLC) with tyrosine kinase receptor inhibitors blocking the Epidermal Growth Factor Receptor (EGFR), as erlotinib.
This drug usually does not induce rapid shrinking of NSCLC tumour explaining why RECIST criteria are less reliable with erlotinib than cytotoxic drugs after 8 weeks of treatment.
Among patients with unresectable NSCLC, 3'-deoxy-3'-18F-fluoro-L-thymidine (18F-FLT) and 18F-2-18F-fluoro-2-deoxy-D-glucose (18F- FDG) Positron Emission Tomography (PET) has identified early responding patients and with better progression-free survival in erlotinib first line and in the second or third line.
To date, none medico-economic study has been conducted to determine if this strategy will be cost-effective.
The purpose of this study is to confirm that an early metabolic imaging with 18 F-FLT and 18FFDG PET could have theranostic issue by identifying at the fourteenth day of erlotinib (second line or more) the subjects that do not respond to erlotinib, i.e. 6 weeks prior to the morphological evaluation based on the new RECIST 1.1, that is typically done at week 8 of erlotinib treatment.
A health economics ancillary study will be achieved. Indeed, recent therapeutic improvements, in particular targeted therapies in NSCLC, have improved quality of life and life expectancy, but have also induce an important increase of the health costs. According to studies, the mean cost of the treatments of NSCLC has been increased by a factor 3 during the 10 last years. More efficient strategies that would permit to stop early with objective endpoints, expensive therapies is a main achievement in thoracic oncology.
The potential clinical impacts of this work are 1) to stop early erlotinib in non-responders and replace another treatment before a deterioration in their physical status, 2) reduce the risk of side effects and costs of unnecessary treatment and 3) to propose a customization treatment after the first line therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 over superior to 18
- •NSCLC proved by a histological biopsy
- •EGFR mutation status known with no activating EGFR mutation
- •indication of erlotinib therapy after at least one previous therapy
- •patients who have signed an informed consent to participate in this study
- •life expectancy exceeding 12 weeks
- •WHO activity score between 0 and 2.
排除标准
- •contraindication for the initiation of erlotinib
- •refusal to sign the consent
- •progressive inflammatory disease
- •infection with the HIV virus
- •other malignant disease
- •life expectancy less than 12 weeks
- •major adults protected by French law
结局指标
主要结局
Early prediction of response to erlotinib therapy by 18F-FLT and 18F-FDG PETscans
时间窗: Six months
The primary endpoint is the correlation between tumour response to erlotinib assessed by morphological imaging by RECIST 1.1 at Day 56 (considered the gold standard) and the change in the uptake of 18F-FLT and 18F-FDG assessed by PET before and at Day 7 after initiation of erlotinib derived from criteria PERCIST. the Kappa test will be used.
次要结局
- Economic study of the early prediction of response to erlotinib therapy by 18F-FLT and 18F-FDG PETscans(Six months)