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EMBRACE studies

EMBRACE I

In 2008 the GEC-ESTRO Gyn network initiated the EMBRACE study which has successfully finalised accrual in December 2015 with a total of 1419 patients (www.embracestudy.dk). The EMBRACE study is internationally recognised as the most ambitious study worldwide to evaluate and benchmark image guided brachytherapy in a prospective multicentre study. The EMBRACE research group is responsible for the clinical research structure, and currently >20 research studies are published (see under references) or are in progress addressing questions such as local, nodal and systemic recurrences; bladder, bowel, and vaginal morbidity; QoL; prognostic and predictive parameters; physics parameters, 3D QA etc. A vaginal substudy is evaluating in more detail vaginal side effects, vaginal dose and patient reported outcome measures.

EMBRACE I coordinators:

  • Richard Pötter (PI) (MUW)
  • Jacob Lindegaard (AUH)
  • Christian Kirisits (MUW)
  • Kari Tanderup (AUH)

RetroEMBRACE

While EMBRACE I data was collected and maturing, the GEC-ESTRO group initiated a retrospective collection of data (retroEMBRACE) on 852 patients from 12 centers treated with IGABT before starting EMBRACE (www.retroembrace.com). The purpose of retroEMBRACE was to compile retrospective IGABT outcome data until mature prospective data became available e.g. from the EMBRACE study.

retroEMBRACE coordinators:

  • Richard Pötter (PI) (MUW)
  • Jacob Lindegaard (AUH)
  • Christian Kirisits (MUW)
  • Kari Tanderup (AUH)
  • Alina Sturdza (MUW)
  • Lars Fokdal (AUH)

EMBRACE II

In 2016, the EMBRACE II study was initiated (www.embracestudy.dk), mainly based on the evaluations within EMBRACE I and RetroEMBRACE. The EMBRACE II interventions address local, nodal and systemic treatment as well as exposure of organs at risk:

  • Prospective use and validation of BT dose volume parameters for GTVres, CTVHR,IR and OARs
  • 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 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

The general aims of the EMBRACE II study are:

  • To systematically implement a dose prescription protocol for IGABT
  • To systematically apply combined IC/IS techniques in BT as appropriate
  • To systematically apply IMRT with daily IGRT as well as advanced image guided adaptive BT in a prospective multi-centre setting
  • To implement systematic contouring, prescription and reporting for EBRT CTV and OARs.
  • To administer EBRT in different targets which are adapted to the risk of nodal and systemic failure: to improve para-aortic and systemic control in high risk patients and not to decrease lymph node control in low risk and intermediate risk patients
  • To systematically administer simultaneous chemotherapy to EBRT to reach prescribed dose in as many patients as possible, in particular in high risk patients
  • To benchmark an outstanding high level of local, nodal and systemic control as well as survival with application of advanced EBRT, BT and chemotherapy within limited overall treatment time
  • To benchmark a low incidence of intermediate and major morbidity as well as a high level of quality of life with application of advanced EBRT, BT and chemotherapy
  • Beside these general aims, there is a significant number of specific aims which refer to the prospective validation of dose volume parameters from the EMBRACE analyses (e.g. dose escalation for large tumors with increased application of IC/IS techniques), to explore and evaluate dose volume parameters for EBRT and to identify prognostic parameters.
  • General and specific hypotheses were formulated for the various interventions (BT, EBRT, chemotherapy) and endpoints (disease, morbidity, quality of life).

The EMBRACE II study is planning substudies on functional MR imaging (coordinators Uulke van der Heide and Kari Tanderup) and translational research (coordinators Remi Nout and Supriya Chopra). Imaging will involve pre-RT quantitative imaging with DCE-MRI, DWI, quantitative T1 and T2. Translational research will be on different levels involving paraffin embedded tissue as well as fresh tissue.

EMBRACE II coordinators:

  • Richard Pötter (PI) (MUW)
  • Kari Tanderup (AUH)
  • Christian Kirisits (MUW)
  • Jacob Lindegaard (AUH)
  • Ina Jürgenliemk-Schulz (UMCU)
  • Astrid de Leeuw (UMCU)