The 6th Embrace Annual Meeting was held in Vienna on 16th and 17th January, 2015. This meeting also marked the official launch of the EMBRACE II Study. Some 70+ people attended. Further details and summary presentations will be available on this site soon.
New CRF: The new form for the 60 to 120 month follow-ups has been added to the Appendix section. Important New Updates to Database. First, the Off-study form has been updated to include the option "Major Protocol Violation". When this is selected then further follow-ups are blocked and no further action needs to be taken for this patient. One example of when this should be used is when no BT was given. Second, the follow-up timeframe has been increased to 10 years.
What is EMBRACE?
EMBRACE is a study on MRI guided brachytherapy (BT) in locally advanced cervical cancer. Today point-based two-dimensional BT is most often used for definitive radiotherapy in cervical cancer. However, MRI guided 3D brachytherapy is increasingly being used in several centres, and the results reported so far are very promising. The major advantage of this technique is the possibility to conform the dose given by BT with regard to both volume (3D) and time (4D). Thus, by repetitive imaging performed before each BT implant it is possible to adapt the dose given by BT to the anatomy of each individual patient taking into account not only the position of organs at risk but also the tumour regression which often is obtained by preceding external beam radiotherapy and chemotherapy. Based on the experience collected so far, the image based BT approach significantly improves the DVH parameters and the improved dose delivered seems to have a major impact on the clinical outcome with a concomitant decrease in the rates of both local failure and morbidity.
The aim of the EMBRACE protocol is to introduce MRI based brachytherapy in a multicenter setting within the frame of a prospective observational study and to correlate image based DVH parameters for the clinical target volume and for organs at risk with outcome. Based on these results, we hope to develop prognostic and predictive statistical models for clinical outcomes including volumetric, dosimetric, clinical and biological risk factors as well as radiobiological parameter estimates that will allow a precise risk assessment in individual patients and aid in the development of new treatment protocols.
Patient registration and reporting will be performed via the internet to a central database accessible for registered investigators through this website. The study coordinator are Richard Pötter (Vienna), Jacob Chr. Lindegaard (Aarhus), Kari Tanderup, (Aarhus) and Christian Kirisits (Vienna). If you would like to hear more about the possibilities to participate in this trial, please contact Ian Dilworth at the study office in Vienna.
Sponsored by: The Medical University of Vienna