Phase II Study of the Efficacy and Safety of a Radiotherapy Dose Complement in the Treatment of Hypoxic Lesions Identified by F-miso PET/CT in Patients With Stage III Non-small-cell Lung Cancer (NSCLC) Not Amenable to Curative Surgical Resection Who Are Candidate for Curative Radio-chemotherapy
试验速览
- 阶段
- 2 期
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Evaluate the rate of local control
研究概览
简要总结
This study will assess the efficacy and safety of a radiotherapy dose complement (boost) in the treatment of hypoxic lesions, measured by F-miso PET/CT, in patients with stage III NSCLC not amenable to surgery and candidate for chemoradiotherapy.
Preliminary studies in head and neck cancers have demonstrated the feasibility and support the medical benefit of this novel approach.
The aim of the study is to assess the efficacy and safety of a radiotherapy dose complement (boost) in this difficult medical condition for which only limited treatment options are available.
详细描述
Background This phase II study will assess the efficacy and safety of a radiotherapy dose complement (boost) in the treatment of hypoxic lesions, measured by F-miso PET/CT, in patients with stage III NSCLC not amenable to surgery and candidate for chemoradiotherapy.
There is a strong theoretical rationale supporting a radiotherapy dose increase in patients with hypoxic pulmonary tumour. F-miso PET enables in vivo identification and localisation of hypoxic tumoral areas, which constitute a target for an increased total dose of radiation therapy. Preliminary studies in head and neck cancers have demonstrated the feasibility and support the medical benefit of this novel approach. To date, no studies investigating non-small-cell lung cancer patients have been performed.
Given the methodological constraints, we propose a Gehan plan optimizing the number of subjects to be enrolled and the budget.
The project team has been working on imaging of radiotherapy targets for NSCLC for many years within a research group identified by the French National Cancer Institute (INCa) in 2005, and part of the axis 3 of Northwest Canceropole (Prof. Gregoire - Prof. Lartigau - Prof. Vera)2. This project was presented at an EORTC meeting "Imaging and radiotherapy" (organised by Dr. Nestlé) on May 28th 2010. It has been approved by the President of ESTRO (Prof. Gregoire) and the members of SFMN (French Society of Nuclear Medicine) and of the SFRO (French Society of Radiation Oncology) during an "Imaging and Hypoxia" Meeting in September 8th, 2010.
The aim of the study is to assess the efficacy and safety of a radiotherapy dose complement (boost) in this difficult medical condition for which only limited treatment options are available.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with stage III non-small-cell lung cancer candidate for curative radio-chemotherapy
- •The final inclusion is granted after completion of a dosimetric study confirming that the dose objectives (minimum dose of 60 Gy in 99% of target volume) and constraints to organs at risk can be achieved.
排除标准
- •Other cancer
- •no evaluable tumor target
- •Absence of binding to FDG-PET tests before primary chemotherapy
- •Patients for which radiotherapy with curative intent is not indicated
- •History of neoplastic disease of less than 5 years or progressive
- •Patient already included in another clinical trial
- •Pregnant, likely to be or during breastfeeding
- •performance index OMS ≥2
- •Indicating renal insufficiency against Cisplatin treatment
- •Protected adults
- •Unable to submit to medical study for reasons geographical, social or physical
- •Patients with poorly controlled diabetes blood sugar ≥10 mmol/L
- •hypersensitivity to FDG or any excipients of the radiopharmaceutical
- •hypersensitivity to Fmiso or any excipients of the radiopharmaceutical
- •Patients unable to understand the study (language ...)
- •Patients not affiliated to the "sécurité social"
结局指标
主要结局
Evaluate the rate of local control
时间窗: 3 month
to evaluate the rate of local control after dose complement in hypoxic lesions \[maximum dose without the fraction of total lung volume receiving more that 20 Gy exceeding 30% of the lung (V20)\], as determined by F-miso PET/CT.
次要结局
- Simultaneous variation of the glucose metabolism and hypoxia during radiotherapy(3 years)
- Predictive value on 1-year survival(1 year)
- Percentage of patients for whom the RT dose could be increased(3 years)
- 3 months and 1 year toxicity(1 year)