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

Not Applicable

Recruiting

• Conditions: Cervical Cancer

• Registration Number: NCT06394297
• Lead Sponsor: Fundacao Champalimaud

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2023-08-04
• Study First Submitted: 2024-01-10
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-30
• Last Update Submitted: 2024-04-30
• Study First Posted: 2024-05-01
• Last Update Posted: 2024-05-01
• Primary Completion: 2025-08-04
• Study Completion: 2026-08-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Local control	through study completion, an average of 3 years	Free from loco-regional relapse
Dosimetric Feasibility of SBRT boost	through study completion, an average of 3 year	Fulfillment of protocol dosimetrical endpoints and constraints
reproducibility of SBRT boost	Accuracy of treatment delivery will be measured during the 15 minutes of treatment delivery time	anatomical accuracy will be confirmed with image guided (CBCT) and online tracking will guarantee a limit of 2mm threshold
Inter/intra fractional target motion	during the 15 minutes of treatment delivery time	3D deviations recorded in CBCT images and electromagnetic recording
Adverse Events	through study completion, an average of 3 years	Treatment related side effects based on CTCAE V5.0

Secondary Outcome Measures

Name	Time	Method
Distant Relapse	through study completion, an average of 3 years	Free from distant relapse
Quality of life metrics	through study completion, an average of 3 years	Change from baseline in European Organisation for Research and Treatment of Cancer quality of life questionnaire N24

Trial Locations

Locations (1)

Champalimaud Foundation; 🇵🇹 Lisboa, Portugal