An International Study on Magnetic Resonance Imaging (MRI)-Guided Brachytherapy in Locally Advanced Cervical Cancer

Summary

Background:

The standard treatment of locally advanced cervical cancer is radio-chemotherapy including external beam radiotherapy (EBRT), brachytherapy (BT) and concomitant chemotherapy with weekly Cisplatin. While image based conformal EBRT is routinely used, prescription and reporting of BT is still based on specific dose points defined in 2D. Thus, for several decades the BT dose has most often been prescribed and reported to the Manchester point A defined according to different traditions.

Recently, a working group from GEC-ESTRO has published recommendations on contouring of tumour target and organs at risk (OAR) as well as on dose volume parameters to be reported for image guided BT in definitive radiotherapy for locally advanced cervical cancer. These recommendations are mainly derived from retrospective single institution experience with MRI based intracavitary BT. 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). Thus, by repetitive imaging performed before each BT implant it is possible adapt the dose given by BT to the anatomy of each individual patient taking into account not only the position of OAR but also the tumour regression which often is obtained by preceding EBRT and chemotherapy. Based on the experience collected so far, the image based BT approach is expected to have a major impact on the clinical outcome with a concomitant decrease in the rates of both local failure and morbidity.

Aims:

* To introduce MRI based 3D-4D BT in locally advanced cervical cancer in a multicenter setting within the frame of a prospective observational study.
* To establish a bench-mark for clinical outcome with image based BT in a large patient population with respect to local control, survival, morbidity and QoL
* To establish a reference material with regard to image based DVH parameters according to the guidelines from the GEC ESTRO working group.
* To correlate image based DVH parameters for CTV and for OAR with outcome
* To develop prognostic and predictive statistical models for clinical outcome including volumetric, dosimetric, clinical and biological risk factors
* To establish radiobiological parameter estimates that will allow a precise risk estimation in individual patients and aid in the development of new treatment protocols

Conditions

• Cervical Cancer

Interventions

RADIATION

3D MRI-guided Brachytherapy

MRI-based 3D-4D brachytherapy in locally advanced cervical cancer

Sponsors & Collaborators

• Aarhus University Hospital

  collaborator OTHER

• UMC Utrecht

  collaborator OTHER

• Leiden University Medical Center

  collaborator OTHER

• KU Leuven

  collaborator OTHER

• Mount Vernon Hospital

  collaborator OTHER

• Institute of Oncology Ljubljana

  collaborator OTHER

• ARTI Institute for Radiation Oncology Arnhem

  collaborator UNKNOWN

• Maastricht University Medical Center

  collaborator OTHER

• Gustave Roussy, Cancer Campus, Grand Paris

  collaborator OTHER

• Tata Memorial Hospital

  collaborator OTHER_GOV

• Kaposvár University

  collaborator OTHER

• Medical College of Wisconsin

  collaborator OTHER

• Leeds Cancer Centre at St. James

  collaborator UNKNOWN

• St. Olavs Hospital

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• British Columbia Cancer Agency

  collaborator OTHER

• Cambridge University Hospitals NHS Foundation Trust

  collaborator OTHER

• Post Graduate Institute of Medical Education and Research, Chandigarh

  collaborator OTHER

• University of Alberta

  collaborator OTHER

• University of Iowa

  collaborator OTHER

• Kuopio University Hospital

  collaborator OTHER

• Oslo University Hospital

  collaborator OTHER

• Hospital of Navarra

  collaborator OTHER

• Medical University of Vienna

  lead OTHER

Principal Investigators

• Richard Pötter, Prof., M.D. · Department of Radiotherapy, Medical University of Vienna

Eligibility

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-07-31

Primary Completion

2021-12-31

Completion

2021-12-31

Countries

• Austria

Study Locations