Actively Recruiting
Image Guided IMRT, Radiochemotherapy and MRI-based IGABT in Locally Advanced Cervical Cancer
Led by Medical University of Vienna · Updated on 2022-03-17
1000
Participants Needed
1
Research Sites
782 weeks
Total Duration
On this page
Sponsors
M
Medical University of Vienna
Lead Sponsor
U
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Image Guided IMRT, Radiochemotherapy and MRI-based IGABT in Locally Advanced Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cancer of the uterine cervix suitable for curative treatment with definitive radio-(chemo)therapy including MRI guided brachytherapy
- Positive biopsy showing squamous-cell carcinoma, adenocarcinoma, or adeno-squamous carcinoma of the uterine cervix
- Staging performed according to FIGO and TNM guidelines
- MRI of the pelvis performed at diagnosis
- MRI, CT, or PET-CT of the retroperitoneal space and abdomen performed at diagnosis
- MRI with the applicator in place during the first brachytherapy session
- Para-aortic metastatic nodes allowed if below L1-L2
- Patient provides informed consent
You will not qualify if you...
- Presence of primary malignancies other than carcinoma in situ of the cervix or basal cell carcinoma of the skin
- Small cell neuroendocrine cancer, melanoma, or other rare cervical cancers
- Metastatic disease beyond the retroperitoneal para-aortic L1-L2 interspace
- Previous pelvic or abdominal radiotherapy
- Previous total or partial hysterectomy
- Combination of preoperative radiotherapy with surgery
- Receiving only brachytherapy or only external beam radiotherapy
- Receiving neo-adjuvant chemotherapy or antineoplastic treatments other than weekly cisplatin, except allowed adjuvant chemotherapy
- Contraindications to MRI or brachytherapy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Medical University of Vienna
Vienna, Austria, 1090
Actively Recruiting
Research Team
R
Richard Pötter, MD
CONTACT
K
Kari Tanderup, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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