TUmor-volume to breast-volume RAtio for improving COSmetic results in breast cancer patients (TURACOS); a randomized controlled trial

BMC Cancer

Study Protocol

A. H. J. Koning¹  M. G. M. Hunink²  M. Lagendijk³  E. L. Vos³  C. Verhoef³  L. B. Koppert³  C. de Monye⁴  W. van Lankeren⁴  J. P. Pignol⁵  C. H. M. van Deurzen⁶  E. M. L. Corten⁷  W. W. Vrijland⁸  J. H. van Dam⁹  C. M. E. Contant^1,10 

[1] Department of Bioinformatics, Erasmus MC, Rotterdam, the Netherlands;Department of Epidemiology and Department of Radiology, Erasmus MC, Rotterdam, the Netherlands;Center for Health Decision Science, Harvard T.H. Chan School of Public Health, Boston, MA, USA;Department of Oncological Surgery, Erasmus MC Cancer Institute, DHA-102, PO Box 5201, 3008, AE Rotterdam, The Netherlands;Department of Radiology, Erasmus MC, Rotterdam, the Netherlands;Department of Radiotherapy, Erasmus MC, Rotterdam, the Netherlands;Department of pathology, Erasmus MC, Rotterdam, the Netherlands;Department of plastic and reconstructive surgery, Erasmus MC, Rotterdam, the Netherlands;Department of surgery, Franciscus Gasthuis, Rotterdam, the Netherlands;Department of surgery, Havenziekenhuis, Rotterdam, the Netherlands;Department of surgery, Maasstad ziekenhuis, Rotterdam, the Netherlands;

关键词: Breast Cancer Patient;    Cosmetic Outcome;    Breast Conserve Surgery;    Oncoplastic Surgery;    Automate Breast Volume Scanner;   

DOI  :  10.1186/s12885-017-3280-y

 received in 2016-12-03, accepted in 2017-04-12,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundCosmetic result following breast conserving surgery (BCS) for cancer influences quality of life and psychosocial functioning in breast cancer patients. A preoperative prediction of expected cosmetic result following BCS is not (yet) standard clinical practice and therefore the choice for either mastectomy or BCS is still subjective. Recently, we showed that tumour volume to breast volume ratio as well as tumour location in the breast are independent predictors of superior cosmetic result following BCS. Implementation of a prediction model including both factors, has not been studied in a prospective manner. This study aims to improve cosmetic outcome by implementation of a prediction model in the treatment decision making for breast cancer patients opting for BCS.Methods/designMulticentre, single-blinded, randomized controlled trial comparing standard preoperative work-up to a preoperative work-up with addition of the prediction model. Tumour volume to breast volume ratio and tumour location in the breast will be used to predict cosmetic outcome in invasive breast cancer patients opting for BCS. Three dimensional (3D)-ultrasonography will be used to measure the tumour volume to breast volume ratio needed for the prediction model. Sample size was estimated based on a 14% improvement in incidence of superior cosmetic result one year after BCS (71% in the control group versus 85% in the intervention group). Primarily cosmetic outcome will be evaluated by a 6-member independent panel. Secondary endpoints include; (1) patient reported outcome measured by BREAST-Q, EORTC-QLQ-C30/BR23 and EQ-5D-5 L (2) cosmetic outcome as assessed through the BCCT.core software, (3) radiation-induced reaction (4) surgical treatment performed, (5) pathological result and (6) cost-effectiveness. Follow-up data will be collected for 3 years after surgery or finishing radiotherapy.DiscussionThis randomized controlled trial examines the value of a preoperative prediction model for the treatment-decision making. It aims for a superior cosmetic result in breast cancer patients opting for BCS. We expect improvement of patients’ quality of life and psychosocial functioning in a cost-effective way.Trial registrationProspectively registered, February 17th 2015, at ‘Nederlands Trialregister - NTR4997’.

【 授权许可】

CC BY   
© The Author(s). 2017