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Image Guided Intensity Modulated External Beam Radiochemotherapy and MRI Based Adaptive BRAchytherapy in Locally Advanced CErvical Cancer (EMBRACEII)
The research group on adaptive image-guided radiotherapy for locally advanced cervical carcinoma completed the protocol for the EMBRACE II study in October 2018. This study will be carried out in the next few years at the University Clinic for Radiotherapy at the Medical University of Vienna and other international partner institutes. EMBRACE II builds on the findings of the current EMBRACE study. These are already implemented in everyday clinical practice in order to further improve the accuracy of the entire therapy of cervical carcinomas, using state-of-the-art techniques of tele- and brachytherapy. The aim of the EMBRACE II study is to maintain and enhance the excellent local tumor control as well as the nodal and systemic control for all tumor stages while minimizing the adverse reaction rates for all affected organs (rectum, sigmoid, urinary bladder, and vagina) to increase the quality of life of patients with cervical carcinomas.
Details
| Lead sponsor | Medical University of Vienna |
|---|---|
| Phase | Phase 2 |
| Status | RECRUITING |
| Enrolment | 1000 |
| Start date | 2016-04 |
| Completion | 2031-04 |
Conditions
- Uterine Cervical Neoplasms
Interventions
- Increased use of IC/IS technique in BT
- Reduction of vaginal source loading
- Systematic utilisation of IMRT
- Utilisation of daily IGRT (set-up according to bony structures)
- EBRT target concept related to the primary tumor (CTV-T) and internal motion; concepts for OAR contouring
- EBRT dose prescription and reporting
- Adaptation of EBRT nodal elective CTV according to risk of nodal and systemic recurrence
- Systemic application of simultaneous chemotherapy
- Reduction of overall treatment time
Primary outcomes
- local control — 5 years
- nodal control — 5 years
- systemic control — 5 years
- overall survival — 5 years
- overall morbidity — 5 years
- health-related quality of life: physical functioning — 5 years
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire. Scores ranging from 0 to 100, higher scores indicating better functioning.
Countries
Austria