VIBE - Virtual Image Guided Brachytherapy Emulation for Locally Advanced Cervical Cancer (LACC)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFundacao Champalimaud

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • SBRT

    Radiation

    SBRT to reproduce HDR BT dose distribution in non-operated patients LACC

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: SBRT for cervical cancerExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dosimetric Feasibility of SBRT boost

Fulfillment of protocol dosimetrical endpoints and constraints

Time frame
through study completion, an average of 3 year
2

reproducibility of SBRT boost

anatomical accuracy will be confirmed with image guided (CBCT) and online tracking will guarantee a limit of 2mm threshold

Time frame
Accuracy of treatment delivery will be measured during the 15 minutes of treatment delivery time
3

Inter/intra fractional target motion

3D deviations recorded in CBCT images and electromagnetic recording

Time frame
during the 15 minutes of treatment delivery time
4

Adverse Events

Treatment related side effects based on CTCAE V5.0

Time frame
through study completion, an average of 3 years

Secondary outcomes

1

Quality of life metrics

Change from baseline in European Organisation for Research and Treatment of Cancer quality of life questionnaire C30

Time frame
through study completion, an average of 3 years
2

Quality of life metrics

Change from baseline in European Organisation for Research and Treatment of Cancer quality of life questionnaire N24

Time frame
through study completion, an average of 3 years
3

Distant Relapse

Free from distant relapse

Time frame
through study completion, an average of 3 years

Other outcomes

Sponsors and contacts

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