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: 2024年8月19日

适应症

试验速览

暂无简介。

•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.

•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.

发起方

Klinik für Strahlenheilkunde