Functional lung avoidance planning guided by lung perfusion PET/CT versus anatomical planning for lung stereotactic body radiotherapy: a double blinded, randomized, controlled trial

planned to be treated in the radiotherapy department of the participating centers with SBRT for primary or secondary lung tumors.

The primary endpoint is the occurrence of symptomatic RILI (grade≥2 lung toxicity as assessed using the CTCAE 5.0) during the year following lung SBRT. This evaluation will be performed by a medical oncologist blinded from the allocated arm.

Quality of life as assessed by the EORTC QLQ-C30,EORTC QLQ-LC29 and EQ-5D-5L questionnaires at 3, 6, 9 and 12 months., - Lung toxicity as assessed using the CTCAE 5.0, RTOG and Late effects in normal tissue-subjective objective management analysis (LENT-SOMA) scales at 3, 6, 9 and 12 months., - Local tumor control., - Progression-free survival at 3, 6, 9 and 12 months., Overall survival at 12 months., Grade 2 or higher lung toxicity as defined for the primary endpoint., Lung perfusion PET/CT imaging at 3 months., To assess the predictive value of the doses delivered to lung functional volumes as compared to the anatomical lung volume on lung perfusion PET/CT imaging at 3 months., To assess the predictive value of the decrease of lung perfusion at 3 months on long term lung toxicity at 12 months.

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France