VIBE

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-04

Study Completion Date

2026-08-04

Brief Summary

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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.

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Detailed Description

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This is a phase I/II feasibility study of hypofractionated, image-guided Volumetric Modulated Arc Therapy (VMAT) Stereotactic Body Radiotherapy (SBRT) to LACC with the aim to reproduce 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.

Eligible patients who consent to participate in the current study will receive 4 image-guided SBRT sessions to a prescription of 7 Gray per fraction to the LACC (HR-CTV) following whole pelvis external beam radiotherapy.

SBRT will start within one week after whole pelvis external beam radiotherapy. The study will enroll a total of 30 patients. After treatment, patients will be followed-up at 1 month, at 3 months (+/- 1 week), at 6 months (+/- 4 weeks), and then every 6 months (+/- 6 weeks) until the end of the 3rd year, then annually until the 5th year.

The equivalence of outcome and toxicity will be measured by comparing the data obtained in the study to literature data regarding the standard modality of brachytherapy. Patients' oncological outcomes, toxicity and quality of life data will be reported.

Conditions

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Cervical Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patients enrolled in this study must have received or planned to receive 45 to 50 Gray in 25 fractions to pelvis with a simultaneous integrated boost (SIB) of 55 Gray in 25 fractions to metabolic active primary lesion and of 55 Gray in 25 fractions to 62.5 Gray in 25 fractions suspicious nodes of prior external beam radiation therapy. Following completion, patients will receive a boost of 28 Gray in 4 fractions using Image Guided Stereotactic Body Radiation Therapy techniques.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SBRT for cervical cancer

SBRT to LACC following whole pelvis external beam radiotherapy

Group Type EXPERIMENTAL

SBRT

Intervention Type RADIATION

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

Interventions

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SBRT

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

Intervention Type RADIATION

Other Intervention Names

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SABR

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No