Image Guided Intensity Modulated External Beam Radiochemotherapy and MRI Based Adaptive BRAchytherapy in Locally Advanced CErvical Cancer

Who is this study for? Adult female patients with Uterine Cervical Squamous Cell Carcinoma, Adenocarcinoma, or Adenosquamous Carcinoma
Status: Recruiting
Location: See location...
Intervention Type: Radiation, Drug, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• Cancer of the uterine cervix considered suitable for curative treatment with definitive radio-(chemo)therapy including MRI guided BT

• Positive biopsy showing squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix.

• Staging according to FIGO and TNM guidelines

• MRI of pelvis at diagnosis is performed

• MRI, CT or PET-CT of the retroperitoneal space and abdomen at diagnosis is performed

• MRI with the applicator in place at the time of (first) BT will be performed

• Para-aortic metastatic nodes below L1-L2 are allowed

• Patient informed consent

Locations
Other Locations
Austria
Medical University of Vienna
RECRUITING
Vienna
Contact Information
Primary
Richard Pötter, MD
richard.poetter@akhwien.at
0043140400
Backup
Kari Tanderup, PhD
karitand@rm.dk
Time Frame
Start Date: 2016-04
Estimated Completion Date: 2031-04
Participants
Target number of participants: 1000
Treatments
Other: Standard arm
General and specific aims of EMBRACEII as well as the multiple quantitative hypotheses are based on technical data, dose volume parameters and clinical results of the prospective observational study EMBRACEI (NCT00920920, 3 year data 2015) and the retrospective RetroEMBRACE (3/5 year data 2015). The performance of EMBRACE II interventions and clinical outcome in terms of disease- (local, nodal, systemic control, OS, CSS) and morbidity-outcome (various organs and endpoints) is thus based on recent clinical evidence with radiochemotherapy and image guided adaptive brachytherapy. The expected effect of EMBRACE II interventions on clinical outcome is estimated from comparative analyses of interventions in subgroups of Retro-/EMBRACE (partly published). Based on the Retro-/EMBRACE benchmark, the estimated outcome including a confidence interval is quantified for each clinical endpoint in the overall cohort as well as different subgroups for an overall expected patient number of 1000.
Related Therapeutic Areas
Sponsors
Collaborators: Hospital Clinic of Barcelona, North Estonia Medical Centre, The Netherlands Cancer Institute, The Christie NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust, Tata Memorial Centre, Tom Baker Cancer Centre, Post Graduate Institute of Medical Education and Research, Chandigarh, University Hospitals Bristol and Weston NHS Foundation Trust, Radiotherapiegroep, Institut Català d'Oncologia, Leiden University Medical Center, Aarhus University Hospital, Erasmus Medical Center, Skane University Hospital, Cross Cancer Institute, Ludwig-Maximilians - University of Munich, Loyola University Chicago, McGill University, Cambridge University Hospitals NHS Foundation Trust, Pamela Youde Nethersole Eastern Hospital, Universitaire Ziekenhuizen KU Leuven, Maastro Clinic, The Netherlands, Gustave Roussy, Cancer Campus, Grand Paris, Rigshospitalet, Denmark, University Hospitals Coventry and Warwickshire NHS Trust, Tuen Mun Hospital, Catharina Ziekenhuis Eindhoven, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Institut Bergonié, Odense University Hospital, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), University of Pittsburgh, National Cancer Institute, Slovakia, Radboud University Medical Center, Institute of Oncology Ljubljana, Princess Margaret Hospital, Canada, M.D. Anderson Cancer Center, UMC Utrecht, Complejo Hospitalario de Navarra, Region Örebro County, Siriraj Hospital, Maisonneuve-Rosemont Hospital, St Thomas' Hospital, London, Liverpool Hospital, Sydney, Oslo University Hospital, Chulalongkorn University, Royal Marsden NHS Foundation Trust, Mount Vernon Cancer Centre, University Hospital Heidelberg
Leads: Medical University of Vienna

This content was sourced from clinicaltrials.gov