EMBRACE II
EMBRACE II is an interventional prospective multicenter study with some areas for observational research. EMBRACE II intends benchmarking excellent local, nodal, distant control and survival rates, as well as morbidity and Quality of Life outcome. The most advanced radiation techniques currently available for cervix cancer treatment will be applied including MRI guided adaptive IMRT for external beam radiotherapy with simultaneously integrated nodal boosting and MRI guided adaptive brachytherapy with intensified use of interstitial needles. This all should be given in combination with the highest standard concomitant chemotherapy. The interventional aims of the EMBRACE II study intend to prospectively evaluate the evidence and outcome derived from the previous RetroEMBRACE and EMBRACE I studies. The prospectively defined interventions address local, nodal and systemic treatment as well as radiation exposure of organs at risk:
- Increased use of IC/IS technique in BT based on systematic adaptive volume contouring for BT
- Reduction of vaginal source loading
- Systematic utilisation of IMRT
- Systematic utilisation of daily IGRT (set-up according to bony structures)
- EBRT target concept related to the primary tumour
- Concepts for OAR contouring
- EBRT dose prescription and reporting
- Adaptation of EBRT nodal elective CTV according to risk of nodal and systemic recurrence
- Systematic application of simultaneous chemotherapy
- Reduction of overall treatment time
For achieving the aimed high standard treatments in this multicenter study, participating centers are provided a quality assurance program for EBRT and brachytherapy including contouring and treatment planning exercises (CCMO). Final validation will also include data evaluation for the first patients submitted.
Patient registration and reporting will be performed to the central database accessible for registered investigators through this website. The study coordinators are Richard Pötter (Vienna), Kari Tanderup (Aarhus), Jacob Lindegaard (Aarhus), Christian Kirisits (Vienna), Ina Jürgenliemk-Schulz (Utrecht) and Astrid de Leeuw (Utrecht).
For additional information about the possibilities to participate in this trial, please contact Tamara Rumpold at the study office in Vienna:(tamara.rumpold@meduniwien.ac.at).