Jannet Beukema

82 Chapter 6 Materials & Methods In this pilot study, we included 40 EC survivors who were treated 5 to 15 years ago. Twenty patients were treated with nCRT followed by surgery. Since the EC population is generally older with several (cardiopulmonary) comorbidities, 20 patients treated with surgery only were included as a control group. During the time frame 2002-2010, our hospital participated in the CROSS trial. At that time, multimodality treatment was not considered standard of care and therefore we expected to include EC survivors with comparable baseline cardiopulmonary risk factors. Because of the limited number of survivors, we included patients that were 2 years before, during and 2 years after the recruitment period of the CROSS trial. Thereafter, nCRT was considered standard of care. nCRT was given according to the CROSS trial with a total dose of 41.4 Gy in 23 fractions combined with weekly concurrent carboplatin and paclitaxel [1]. 3-Dimensional conformal radiotherapy was used during this time frame. Beam directions usually consisted of two opposing beams, adding a third, lateral beam to decrease the dose to the heart. According to the protocol, the volume of lung tissue receiving 20 Gray (V20) did not exceed 30 %, the V40 of the heart did not exceed 30%, and the V30 of the liver did not exceed 60%. The current study was approved by the local ethics committee and registered in clinicaltrials.gov (NCT03396614). All patients treated for EC with curative surgery plus or minus neoadjuvant CRT were selected from our institutional database. After verification of survival and disease status with their general practitioners, we contacted patients whether they were willing to participate in this study. In total, 36 nCRT patients and 40 control patients were contacted. Written informed consent was given by 22 and 26 patients respectively. Inclusion was done in order of response. Participants visited our hospital for one day. They were interviewed on issues concerning medical history and physical functioning. In addition, the EORTC Quality of life questionnaires (EORTC-QLQ), measuring cancer patients’ physical, psychological and social health (C-30) and OES-18, focusing on EC cancer patients, were completed. After a routine physical examination, a 6-minute walking test (6MWT) was performed as measurement for functional capacity and physical fitness [20,21]. Blood biomarkers were taken to evaluate myocardial damage: NT pro BNP is considered an early biomarker for heart failure and is prognostic for cardiac events and overall survival [22] and HS-TNT is considered as a measurement

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