We use cookies necessary to giving you a better online experience. By using our website you consent to all cookies in accordance with our Privacy Policy.
Yes, I accept
Menu
Search Opener
Current and upcoming clinical studies

EMBRACE II

  • Coordinators: Richard Pötter, Kari Tanderup, Ina Jürgenliemk Schulz, Christian Kirisits, Remi Nout, Max Schmid
  • Patient enrollment: from 2016-2021
  • Description: EMBRACE II aims to implement interventions in terms of: systematic use of IC/IS application techniques, dose prescription protocol for IGABT, introduction of tumor related target concept (at diagnosis) and risk adaptive elective nodal target selection for IMRT; risk adaptive margin concept for IGRT (ITV/PTV). To benchmark related to a well-defined intervention strategy for IGABT, IMRT/IGRT and radio-chemotherapy an outstanding level of local, nodal, systemic control, and overall survival as well as excellent outcome of morbidity and quality of life.
  • Research: ongoing research in EBRT and brachytherapy treatment characteristics and acute morbidity
     

Translational research EMBRACE I and II

  • IQ EMBRACE:
    • Coordinators: Petra van Houdt, Uulke van der Heide, Kari Tanderup
    • Description: functional imaging, linking imaging data to clinical outcome
  • BIO EMBRACE:
    • Coordinators: Supriya Chopra, Remi Nout
    • Description: molecular biomarkers, linking patterns of biomarker expression to clinical outcome with a retrospective and prospective part. For a first research project paraffin embedded tissue of EMBRACE-I patients has been collected from multiple international sites and immunohistochemically staining has performed.
       

EMBRAVE

  • Patient enrollment: from 2022 ongoing
  • Description: A prospective multi-center clinical registration study on radiochemotherapy and IGABT in vaginal cancer (EMBRAVE), according to the 2020 published target concept has been launched and first patients have been entered. This study will overall follow the EMBRACE-I template aiming to evaluate the target concept; benchmark results and derive evidence based recommendations for dose planning aims and constraints for vaginal cancer. PI Remi Nout.
     

EMBRACE low risk study

  • Coordinators: Remi Nout, Kari Tanderup
  • Patient enrollment: planned from end of 2023
  • Description: The EMBRACE low-risk study aims to reduce treatment related acute and late morbidity in low-risk cervix cancer patients through dose and volume de-escalation of EBRT and combined EBRT+BT dose. Furthermore, the overall treatment time and number of EBRT and BT fractions will be reduced with the aim of lessening the burden of the treatment for the patient and improving the efficiency for the hospitals through reduction of number of EBRT and BT fractions. It is hypothesized that radiotherapy de-escalation can be carried out without compromising pelvic control. Since the optimal radiotherapy dose for low-risk patients is unknown, the study is designed to investigate dose de-escalation in a stepwise manner. While continuous monitoring safety (pelvic control), the design allows further de-escalation early on when interim results are favorable.
     

RetroCOSMOS

  • Coordinators: Supriya Chopra, Remi Nout
  • Patient registration: from 2023
  • Description: The RetroCOSMOS study aims to build more evidence on the role of radiotherapy in the context of (oligo)metastatic/recurrent cervical cancer, including re-irradiation. An international multicenter retrospective cohort study has opened for inclusion of patients via an electronic web-based CRF system.
     

Definitive endometrium

  • Coordinator: Angeles Rovirosa
  • Description: A multicentric retrospective collection of data has been carried out. 183 patients have been collected.
  • Research: The cohort with patients treated with brachytherapy alone has been published: Exclusive 3D-brachytherapy as a good option for stage-I inoperable endometrial cancer: a retrospective analysis in the gynaecological cancer GEC-ESTRO Working Group. Rovirosa A, Zhang Y, Chargari C, Cooper R, Bownes P, Wojcieszek P, Stankiewicz M, Hoskin P, Van der Steen-Banasik E, Segedin B, Najjari D, Pötter R, Tanderup K, Van Limbergen E; Endometrial Task Group in the Gynecological Cancer Working Group; GEC-ESTRO Working Group. Clin Transl Oncol. 2022 Feb;24(2):254-265. doi: 10.1007/s12094-021-02680-z. Epub 2021 Jul 16. PMID: 34272660
     

EMBRACE high-risk study

  • Coordinators: Remi Nout, Supriya Chopra, Ingrid Boere
  • In this extension to the EMBRACE study, the addition of immunotherapy and anti-vascular endothelial growth factor will be tested in high-risk patients and those who have responded poorly to EBRT. The immunotherapy will be positioned close to the BT source in an attempt to synergise immunotherapy and high-dose radiotherapy. The study is expected to begin recruitment in mid-2024.
     

CT EMBRACE registration study

  • Coordinator: Umesh Mahantshetty
  • Status: protocol in preparation
  • This study is designed to introduce the use of CT-based 3D-4D BT to treat patients with locally advanced cervical cancer. It will be a multicentre project within the framework of a prospective observational study, and thereby the aim is to establish a benchmark for clinical outcomes after the use of CT-based BT in a large patient population with respect to local control, survival, morbidity and QoL. Furthermore, another aim is to establish a reference for image-based dose-volume histogram (DVH) parameters according to the guidelines from the GEC ESTRO WG for CT IGABT settings, and to correlate image-based DVH parameters for clinical target volumes and organs at risk with outcomes.
     

MR EMBRACE   registration study

  • Coordinator: Max Schmid
  • Status: protocol in preparation
  • The aim of this study is to collect real-world data regarding cervical cancer patients who have been treated through the use of either standard-of-care radiochemotherapy, which includes MRI-guided BT, according to the ESGO-ESTRO-ESP guideline; or alternative schedules for unsuitable or frail patients. The study will also facilitate the prescription of evidence-based doses by providing a decision-support tool.