NCT03617133 Image Guided IMRT, Radiochemotherapy and MRI-based IGABT in Locally Advanced Cervical Cancer
| NCT ID | NCT03617133 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Medical University of Vienna |
| Condition | Uterine Cervical Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2016-04 |
| Primary Completion | 2021-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 1,000 participants in total. It began in 2016-04 with a primary completion date of 2021-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Richard Pötter, MD
PRINCIPAL INVESTIGATOR
Medical University of Vienna
Frequently Asked Questions
Who can join the NCT03617133 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 99 Years, studying Uterine Cervical Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03617133 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03617133 currently recruiting?
Yes, NCT03617133 is actively recruiting participants. Contact the research team at richard.poetter@akhwien.at for enrollment information.
Where is the NCT03617133 trial being conducted?
This trial is being conducted at Vienna, Austria.
Who is sponsoring the NCT03617133 clinical trial?
NCT03617133 is sponsored by Medical University of Vienna. The principal investigator is Richard Pötter, MD at Medical University of Vienna. The trial plans to enroll 1,000 participants.