ESTRO 36 Abstract Book
S395 ESTRO 36 _______________________________________________________________________________________________
before treatment, 2 and 7 weeks, as well as 3 monthly after SBRT for 2 years of follow up (FU) or until death. Here we report on the primary descriptive analysis of early changes from baseline to 7 week-FU. A clinically significant change was defined as a change in HRQOL scores of >=10 points compared with baseline. Results QoL was assessed in 97 patients. Compliance was 92% at baseline and 85% at 7 weeks after SBRT. Overall, regarding the whole cohort, the Qol /Global Health Status (GHS), all function scores, and all inquired symptoms were unchanged from baseline until 7 weeks after SBRT. However, patients who initially scored their QoL / GHS below the median of 50 showed a clinically relevant improvement in QoL / GHS (delta 14), Emotional Function (delta 15.12), and loss of appetite (delta 15.12). In contrary, patients with initial scores of >= the median of 50 showed no clinically relevant alterations over time. Patients with an initial low Karnofsky Index (KI) <=80 revealed a clinical relevant improvement in Emotional Function (delta 10.2), whereas patients with high initial KI >80 did not show any alterations. Univariate, multivariate and further subgroup analysis are object of current investigations. Conclusion In short-term FU QoL is well maintained after pulmonary SBRT for elderly and comorbid inoperable patients. Interestingly, especially patients with initially low QoL/GHS may benefit from SBRT with respect to QoL. Further analyses of predefined predictors are in progress. Poster: Clinical track: Health services research / health economics PO-0750 Failure to publish the results of clinical trials in oncology is skewing our medical practice P. Gallego 1 , J. Perez-Alija 1 , E. Ambroa 2 , I. Linares 3 , A. Pedro 1 1 Hospital Plató, Radiation Oncology Department, Barcelona, Spain 2 Consorci Sanitari de Terrasa, Medical Physics Unit- Radiation Oncology Department, Terrasa, Spain 3 Institut Català d'Oncologia, Radiation Oncology Department, L'Hospitalet de Llobregat, Spain Purpose or Objective Clinical trials produce the best data available for decision- making in modern evidence-based medicine. Publication of all trials conducted in oncology is needed to fully determine the benefits and risks of treatments currently in use in our clinics. A US Federal law requires responsible parties of all interventional trials to submit summary results to the ClinicalTrials.gov database 12 months after the completion date. We aimed to determine how many of the interventional phase 3 and 4 trials conducted in oncology were in compliance with the law and make their results publicly available. We also analysed if there was any difference when we take into account only radiation oncology trials or molecular oncology ones. Finally we estimated how many of these trials have not published in a peer-reviewed journal (PRJ). Material and Methods As of 6 May 2016, the ClinicalTrials.gov database was searched for interventional phase 3 and 4 trials in Oncology with a primary completion date before 1 January 2013. We determined how many of these registry entries have not published the compulsory deposition of their results in the database. We then categorised our data into a radiation oncology subset and a molecular oncology one. For each trial registered in the database, ClinicalTrials.gov also displayed publication citations either submitted by sponsors or investigators, or automatically indexed by ClinicalTrials.gov. We reviewed
Conclusion Older patients have a remarkable benefit from palliative RT. A higher age should not be a reason to withhold palliative RT. PO-0749 Early impact of pulmonary SBRT on Quality of Life: Benefit for patients with low initial QoL/GHS S. Adebahr 1,2 , M. Hechtner 3 , N. Schräder 1 , T. Schimek- Jasch 1 , K. Kaier 4 , V. Duncker- Rohr 5 , F. Momm 5 , J. Gärtner 6 , A.L. Grosu 1,2 , U. Nestle 1,2 1 University Medical Center Freiburg, Department of Radiation Oncology, Freiburg, Germany 2 German Cancer Consortium DKTK, Partner Site Freiburg, Freiburg, Germany 3 University of Mainz, Department of Medical Biostatistics- Epidemiology and Informatics, Freiburg, Germany 4 Faculty of Medicine and Medical Center - University of Freiburg, Institute of Medical Biometry and Statistics, Freiburg, Germany 5 St. Josefsklinik Offenburg, Department of Radio- oncology, Offenburg, Germany 6 Medical Center- Faculty of Medicine- University of Freiburg, Clinic for Palliative Care, Freiburg, Germany Purpose or Objective To determine the early impact of stereotactic body radiotherapy (SBRT) on the quality of life (QoL) of inoperable elderly and comorbid patients with small pulmonary lesions. Material and Methods 100 inoperable patients with pulmonary lesion <= 5cm (early stage NSCLC or ≤ 2 pulmonary metastases of a controlled primary tumor) were treated with SBRT (3x12.5 Gy or 5X 7Gy to 60% isodose) from 02/2011 to 12/2014 within the prospective, monocenter phase II STRIPE trial. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30 and the QLQ LC13 lung cancer-specific questionnaire were used to evaluate quality of life. Assessments were done
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