Novel Approach to Radiotherapy in Locally Advanced Lung Cancer - Heterogeneous FDG-guided Dose Escalation With Concomitant Navelbine®
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 330
- 试验地点
- 13
- 主要终点
- Locoregional control (Tumor recurrency is assessed by scheduled CT (of the thorax and upper abdomen)
研究概览
简要总结
To investigate the effect of escalation of radiation dose to tumor and lymph nodes based on an inhomogeneous dose distribution controlled by FDG-PET positive areas compared to a standard homogeneous dose spread
详细描述
To investigate the effect of escalation of radiation dose to tumor and lymph nodes based on an inhomogeneous dose distribution controlled by FDG-PET-positive areas compared to a standard homogeneous dose spread.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Two independent radiation plans are made before randomization to ensure best available plans for both arms and trial.
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
- •Patients with histologically or cytologically proven locally advanced NSCLC stage IIB to IIIB
- •Performance status 0-1
- •Able to comply with treatment and follow study and follow-up procedures
- •Women must have negative pregnancy test
- •Signed, informed consent
- •Plan for radiotherapy with conventional 66 Gy/ 33 F, which meets all dosing limits two normal tissue must be available
排除标准
- •Any unstable systemic disorder (including infection , unstable angina, congestive heart failure , severe liver , kidney or metabolic disease)
- •Need for nasal oxygen
- •Former thoracic radiotherapy, unless there is no significant overlap with previous fields
- •Any other active malignant disease
- •Unable to take oral medications or needing intravenous nutrition
- •Nursing women
结局指标
主要结局
Locoregional control (Tumor recurrency is assessed by scheduled CT (of the thorax and upper abdomen)
时间窗: 5-7 years
Tumor recurrency is assessed by scheduled CT (of the thorax and upper abdomen ) every 3 months combined with PET/CT every 9 months or if occurrence is clinically suspected. Suspicion of tumor relapse local, regional or distant should be verified by biopsy. Date of detected recurrence is the date of the imaging modality suspecting relapse. The patient will be censured at death without local relapse.
次要结局
- Progression free survival(15 years)
- Toxicity (graded after CTCAE 4.0 assessed by physician)(10 years)
- Survival(15 years)
研究者
Olfred Hansen
MD
Odense University Hospital