Image Guided IMRT, Radiochemotherapy and MRI-based IGABT in Locally Advanced Cervical Cancer

• Status: Recruiting
• Trial end date: 2031-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Vienna
• Collaborators: Aarhus Universitetshospital; Academisch Medisch Centrum (AMC) Amsterdam; Addenbrooke's NHS Trust Cambridge; Antoni van Leeuwenhoekziekenhuis (AVL) Amsterdam; Bristol Haematology & Oncology Centre; Catharina Ziekenhuis Eindhoven; Chulalongkorn University Bangkok; Clinic Hospital Universitari Barcelona; Complejo Hospitalario de Navarra; Cross Cancer Institute Edmonton; Erasmus University Medical Center Rotterdam; Fondazione IRCCS Istituto Nazionale dei Tumori, Milano; Guy's and St Thomas' NHS Foundation Trust London; Hôpital Maisonneuve-Rosemont Montréal; Institut Bergonié Bordeaux; Institut Català d'Oncologia (ICO) Barcelona; Institute Gustave Roussy Paris; Institute of Oncology Ljubljana; Klinikum der Universität München - Campus Großhadern/Innenstadt; Leeds Teaching Hospitals NHS Trust; Leiden University Medical Center (LUMC); Liverpool Hospital, Sydney; Loyola University Chicago; Maastro Maastricht; McGill University; MD Anderson Cancer Center University of Texas; Mount Vernon Cancer Centre - East & North Hertfordshire NHS Trust London; National Cancer Institute Bratislava; North Estonia Medical Centre Foundation Tallinn; Odense Universitetshospital; Pamela Youde Nethersole Eastern Hospital, Hong Kong; Post Graduate Institute of Medical Education and Research (PGIMER) Chandigarh; Princess Margaret Cancer Centre Toronto; Radboudumc Nijmegen; Radiotherapiegroep; Region Örebro County; Rigshospitalet, Denmark; Royal Marsden Hospital London; Siriraj Piyamaharajkarun Hospital Bangkok; Skåne University Hospital Lund; Tata Memorial Center Mumbai; The Christie NHS Foundation Trust Manchester; The Norwegian Radiumhospital - Oslo University Hospital HF; Tom Baker Cancer Center Calgary; Tuen Mun Hospital Hong Kong; UMC Utrecht Cancer Center; University Hospital Coventry & Warwickshire Coventry; University Hospital Heidelberg; UPMC Hillman Cancer Center Pittsbrugh; UZ Leuven

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin

• Small cell neuroendocrine cancer, melanoma and other rare cancers in the cervix

• Metastatic disease above and beyond the retroperitoneal para-aortic L1-L2 interspace

• 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 neo-adjuvant chemotherapy or other forms of antineoplastic treatment apart from weekly concomitant cisplatin (40 mg/2). However, adjuvant chemotherapy in the form of 4 courses of 3 weekly Carboplatin (AUC 5) and Paclitaxel (155 mg/m2) is allowed according to departmental policy.

• Contra indications to MRI

• Contra indications to BT