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

RECRUITINGN/ASponsored by Fundacao Champalimaud
Actively Recruiting
PhaseN/A
SponsorFundacao Champalimaud
Started2023-08-04
Est. completion2025-08-04
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted

Summary

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

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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.

Conditions2

CancerCervical Cancer

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