Optimisation of Radiotherapy-Planning in Patients With Inoperable Locally Advanced Non-Small-Cell Lung Cancer by FDG-PET
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- time to local progression
研究概览
简要总结
Simultaneous radio-chemotherapy in advanced non-small cell lung cancer. The study focusses on a randomised comparison of conventional radiotherapy planning with irradiation of macroscopic tumor and lymph nodes together with prophylactic target volumes vs. irradiation only of FDG-positive lesions.
Primary endpoint is the local disease control in the chest.
详细描述
Simultaneous radio-chemotherapy in advanced non-small cell lung cancer. The study focusses on a randomised comparison of conventional radiotherapy planning with irradiation of macroscopic tumor and lymph nodes together with prophylactic target volumes vs. irradiation only of FDG-positive lesions.
Primary endpoint is the local disease control in the chest
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
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
- •histologically proved NSCLC
- •UICC-stage I-III, no resection planned
- •complete staging < 6 wks before treatment including cranial CT
- •ECOG <3, Karnofsky-Index >60%
- •age > 18 <
- •FEV1 > 1,0 l or >35%
- •RT-planning according to protocol feasible
- •chemotherapy feasible
- •written informed consent
排除标准
- •neuroendocrine tumors, plain broncho-alveolar-cell ca.
- •distant metastases, supraclavicular lymph node metastases
- •malignant pleural effusion
- •resection of actual tumor performed
- •inclusion in other study protocol
- •chemotherapy due to actual tumor before FDG-PET
- •induction-chemotherapy
- •acute vena cava superior syndrome
- •second malignancy other than basalioma
- •pregnancy, lactation
- •heart insufficiency NYHA III/IV
- •pneumoconiosis with active inflammatory changes of mediastinal lymph nodes
- •acute broncho-pulmonary infection at time of PET-examination
结局指标
主要结局
time to local progression
时间窗: actuarial
Time from randomization to first evidence of local progression or last follow up
次要结局
- Overall survival(actuarial)
- normal tissue toxicity(actuarial)
- in and out field progression(actuarial)
研究者
Prof. Dr. Ursula Nestle
Prof. Dr. Ursula Nestle, Universitätsklinikum Freiburg
Arbeitsgemeinschaft Nuklearmedizin und Strahlentherapie der DEGRO und DGN