You are here:

Intervention protocol 12

EMBRACE: An International Study on MRI-guided Brachytherapy in Locally Advanced Cervical Cancer

Objectives Today two-dimensional brachytherapy (BT) based on specific dose points (point-A, ICRU reference points) is most often used for definitive radiotherapy in cervical cancer. However, MRI guided BT is increasingly being used with promising results. 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). 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 dose-volume parameters for the clinical target volume and for organs at risk with outcome.
Study outline (intervention) The study will be running from Oct. 2008 and the aim is to recruit > 600 patients in 3 years and follow them for at least another 3 years. More than 20 major centres around the world with expertise in MRI guided BT will participate. Local control within the specific BT target and morbidity related to normal tissue in the pelvis are the primary outcome measures. Secondary endpoints include regional control, disease free survival and overall survival. Morbidity will be scored by use of the Common Terminology Criteria for Adverse Events (CTCAE v3.0). QoL will also be systematically recorded by use of EORTC C30+CX24.
Expected impact Based on the experience collected so far, the MRI based BT approach significantly improves the dose-volume parameters and the improved dose delivery seems to have a major impact on the clinical outcome with a concomitant 50% decrease in the rates of both local failure and morbidity.
Linkages with work packages WP 1, 2, 3, 4, 7, 8, 9. WP02 and WP04 BT target definition and to obtain knowledge of the tumour biology within the BT target itself. From WP01 MRI guided biopsies; WP03 image management; WP07 MR compatible markers; from WP08 small dosimeters; WP09 storage and analysis of 3D data