DRKS00002178已完成未知
PET-Plan - Optimization of radiotherapy planning in patients with inoperable locally advanced NSCLC using F-18-FDG-PET - PET-PLA
Klinik für Strahlenheilkunde0 个研究点目标入组 205 人开始时间: 2012年4月24日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 205
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Written informed Consent.
- •Histologically proven NSCLC, UICC-stage II-III.
- •Resection planned according to interdisciplinary consensus.
- •Complete staging < 6 weeks before initiation of treatment including cranial MRI or, if not possible, cranial CT.
- •ECOG < 3, Karnofsky-Index > 60%.
- •Age > 18 years. FEV1 > 1,0 l or >35% of expected value.
- •RT-planning according to both protocol arms feasible.
- •Application of chemotherapy feasible according to the treating study center specific standards.
排除标准
- •Neuroendocrine tumors or broncho-alveolar-cell carcinoma.
- •Distant metastases, supraclavicular lymph node metastases.
- •Malignant pleural or pericardial effusion.
- •Acute superior vena cava syndrome.
- •Recent pulmonary resection of the present NSCLC.
- •Parallel participation in another clinical trial. Chemotherapy or targeted therapy for to present NSCLC before study inclusion.
- •Induction chemotherapy.
- •Second malignancy (other than basalioma) within 2 years of study inclusion.
- •Pregnancy or lactation.
- •Application of chemotherapy not possible according to study center institutional standards.
- •Heart insufficiency NYHA III/IV.
- •FDG-PET associated exclusion criteria:
- •Detection of distant metastases or a secondary malignancy. Downstaging or change of therapeutical concept.
- •Acute broncho-pulmonary infection at time of the FDG-PET acquisition.
- •Active inflammatory changes of mediastinal lymph nodes associated with pneumoconiosis, sarcoidosis or tuberculosis.
- •FDG-PET acquisition not in radiotherapy planning position.
- •Co-registration of FDG-PET and CT not according to protocol guidelines.
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