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

NCT00920920 | Unknown

• 1 other identifier: EMBRACE 1
• Study Type: observational
• Target: 1,416
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

3D-4D MRI-based Brachytherapy; Cervical Cancer; Multicenter Clinical Study; Locally advanced cervical cancer

Outcome Measures

Primary Outcomes (1)

• local control/morbidity

  5 years

Secondary Outcomes (4)

• regional control

  5 years

• disease free survival

  5 years

• overall survival

  5 years

• quality of life (QoL)

  5 years

Interventions

3D MRI-guided Brachytherapy RADIATION

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

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients to be included: Patients with newly biopsy proven squamous carcinoma, adenocarcinoma or adeno-squamous carcinoma of the uterine cervix, FIGO stage IB, IIA, IIB, IIIA, IIIB and IVA in whom definitive radiotherapy with curative intent is planned are qualified for the study. Patients with para-aortic metastatic nodes (stage IVB) to the level of L2 are also eligible but patients with further dissemination are not. Staging should as a minimal include gynaecological examination, MRI of the pelvis, abdominal CT or MRI and chest radiography. Further investigations are applied if necessary (e.g. cystoscopy, rectoscopy) or normally done according to institutional practice (e.g. PET-CT).

You may qualify if:

• 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

You may not qualify if:

• Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin
• Metastatic disease beyond para-aortic region (L1-L2)
• Previous pelvic or abdominal radiotherapy
• Previous total or partial hysterectomy
• Combination of preoperative radiotherapy with surgery
• Patients receiving BT only
• Patients receiving EBRT only
• Patients receiving neoadjuvant chemotherapy
• Contra indications to MRI
• Contra indications to BT
• Active infection or severe medical condition endangering treatment delivery
• Pregnant, lactating or childbearing potential without adequate contraception

Sponsors & Collaborators

• Medical University of Vienna: lead
• Aarhus University Hospital: collaborator
• UMC Utrecht: collaborator
• Leiden University Medical Center: collaborator
• KU Leuven: collaborator
• Mount Vernon Hospital: collaborator
• Institute of Oncology Ljubljana: collaborator
• ARTI Institute for Radiation Oncology Arnhem: collaborator
• Maastricht University Medical Center: collaborator
• Gustave Roussy, Cancer Campus, Grand Paris: collaborator
• Tata Memorial Hospital: collaborator
• Kaposvár University: collaborator
• Medical College of Wisconsin: collaborator
• Leeds Cancer Centre at St. James's University Hospital: collaborator
• St. Olavs Hospital: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• British Columbia Cancer Agency: collaborator
• Cambridge University Hospitals NHS Foundation Trust: collaborator
• Post Graduate Institute of Medical Education and Research, Chandigarh: collaborator
• University of Alberta: collaborator
• University of Iowa: collaborator
• Kuopio University Hospital: collaborator
• Oslo University Hospital: collaborator
• Hospital of Navarra: collaborator

Study Sites (1)

MUV

Vienna, 1090, Austria

Location

Related Publications (2)

• Schmid MP, Lindegaard JC, Mahantshetty U, Tanderup K, Jurgenliemk-Schulz I, Haie-Meder C, Fokdal LU, Sturdza A, Hoskin P, Segedin B, Bruheim K, Huang F, Rai B, Cooper R, van der Steen-Banasik E, Van Limbergen E, Pieters BR, Petric P, Ramazanova D, Ristl R, Kannan S, Hawaldar R, Ecker S, Kirchheiner K, Tan LT, Nout R, Nesvacil N, de Leeuw A, Potter R, Kirisits C; EMBRACE Collaborative Group. Risk Factors for Local Failure Following Chemoradiation and Magnetic Resonance Image-Guided Brachytherapy in Locally Advanced Cervical Cancer: Results From the EMBRACE-I Study. J Clin Oncol. 2023 Apr 1;41(10):1933-1942. doi: 10.1200/JCO.22.01096. Epub 2023 Jan 4.

  PMID: 36599120 DERIVED

• Potter R, Tanderup K, Schmid MP, Jurgenliemk-Schulz I, Haie-Meder C, Fokdal LU, Sturdza AE, Hoskin P, Mahantshetty U, Segedin B, Bruheim K, Huang F, Rai B, Cooper R, van der Steen-Banasik E, Van Limbergen E, Pieters BR, Tan LT, Nout RA, De Leeuw AAC, Ristl R, Petric P, Nesvacil N, Kirchheiner K, Kirisits C, Lindegaard JC; EMBRACE Collaborative Group. MRI-guided adaptive brachytherapy in locally advanced cervical cancer (EMBRACE-I): a multicentre prospective cohort study. Lancet Oncol. 2021 Apr;22(4):538-547. doi: 10.1016/S1470-2045(20)30753-1.

  PMID: 33794207 DERIVED

Related Links

• Official homepage of the EMBRACE study

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Richard Pötter, Prof., M.D.

  Department of Radiotherapy, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 12, 2009
• First Posted: June 15, 2009
• Study Start: July 1, 2008
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 25, 2021

Record last verified: 2021-03

Locations

AU (1)