About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
SBRT
RadiationSBRT to reproduce HDR BT dose distribution in non-operated patients LACC
Treatment groups
Trial outcomes
Primary outcomes
Dosimetric Feasibility of SBRT boost
Fulfillment of protocol dosimetrical endpoints and constraints
reproducibility of SBRT boost
anatomical accuracy will be confirmed with image guided (CBCT) and online tracking will guarantee a limit of 2mm threshold
Inter/intra fractional target motion
3D deviations recorded in CBCT images and electromagnetic recording
Adverse Events
Treatment related side effects based on CTCAE V5.0
Secondary outcomes
Quality of life metrics
Change from baseline in European Organisation for Research and Treatment of Cancer quality of life questionnaire C30
Quality of life metrics
Change from baseline in European Organisation for Research and Treatment of Cancer quality of life questionnaire N24
Distant Relapse
Free from distant relapse
Sponsors and contacts
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