Clinical trial · Interventional
Image Guided IMRT, Radiochemotherapy and MRI-based IGABT in Locally Advanced Cervical Cancer
Image Guided Intensity Modulated External Beam Radiochemotherapy and MRI Based Adaptive BRAchytherapy in Locally Advanced CErvical Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Cervical Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adaptation of EBRT nodal elective CTV according to risk of nodal and systemic recurrence | Radiation | — | UNRESOLVED |
| EBRT dose prescription and reporting | Radiation | — | UNRESOLVED |
| EBRT target concept related to the primary tumor (CTV-T) and internal motion; concepts for OAR contouring | Radiation | — | UNRESOLVED |
| Increased use of IC/IS technique in BT | Radiation | — | UNRESOLVED |
| Reduction of overall treatment time | Other | — | UNRESOLVED |
| Reduction of vaginal source loading | Radiation | — | UNRESOLVED |
| Systematic utilisation of IMRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Standard arm
- description
- 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.
- interventionNames
- Radiation: Increased use of IC/IS technique in BT
- Radiation: Reduction of vaginal source loading
- Radiation: Systematic utilisation of IMRT
- Radiation: Utilisation of daily IGRT (set-up according to bony structures)
- Radiation: EBRT target concept related to the primary tumor (CTV-T) and internal motion; concepts for OAR contouring
- Radiation: EBRT dose prescription and reporting
- Radiation: Adaptation of EBRT nodal elective CTV according to risk of nodal and systemic recurrence
- Drug: Systemic application of simultaneous chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available