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RecruitingNot ApplicableNCT06394297

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)

Sponsor

Fundacao Champalimaud

Enrollment

30 participants

Start Date

Aug 4, 2023

Study Type

INTERVENTIONAL

Conditions

Cervical Cancer

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria8

  • 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 Criteria8

  • 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.

Interventions

RADIATIONSBRT

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

Locations(1)

Champalimaud Foundation

Lisbon, Portugal

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NCT06394297

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