Clinical trial · Interventional
VIBE - Virtual Image Guided Brachytherapy Emulation for Locally Advanced Cervical Cancer (LACC)
A Phase I/II Study for Image Guided Stereotactic Body Radiation Therapy Boost for Definitive Treatment of Locally Advanced Cervical Cancer (LACC)
NCT06394297CI-TRIAL-00076652VIBEunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study will evaluate the role of SBRT with the aim to reproduce high dose rate brachytherapy (HDR BT) dose distribution by means of external beam radiotherapy in the radical treatment in patients with LACC. The study will employ devices to accurately reproduce pelvic anatomy and mitigate target motion and will make use of real-time online tracking.
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 |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SBRT for cervical cancer
- description
- SBRT to LACC following whole pelvis external beam radiotherapy
- interventionNames
- Radiation: SBRT
Primary outcomes (5)
- measure
- Dosimetric Feasibility of SBRT boost
- timeFrame
- through study completion, an average of 3 year
- description
- Fulfillment of protocol dosimetrical endpoints and constraints
- measure
- reproducibility of SBRT boost
- timeFrame
- Accuracy of treatment delivery will be measured during the 15 minutes of treatment delivery time
- description
- anatomical accuracy will be confirmed with image guided (CBCT) and online tracking will guarantee a limit of 2mm threshold
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Cancer of the uterine cervix suitable for curative treatment with definitive radio-chemotherapy * Biopsy proven showing squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix. * Pelvic MRI. * MRI and Positron emission tomography (PET-CT) of the retroperitoneal space and abdomen at diagnosis is performed. * Stage IIB to IVA according to International Federation of Gynecological and Obstetrics (FIGO) and TNM guidelines. * Planning MRI with the applicator in place for the SBRT boost. * Para-aortic metastatic nodes below L1-L2 are allowed. * Study specific signed 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 paraaortic L1-L2 interspace. * Previous pelvic or abdominal radiotherapy. * Previous total or partial hysterectomy. * Contra-indications to MRI. * Severe psychiatric condition. * Severe, active co-morbidity.
References
Publications (0)
Data not yet available
No reference posted for this study.