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

Cervical Cancer Clinical Trial

— VIBE  

Official title:

A Phase I/II Study for Image Guided Stereotactic Body Radiation Therapy Boost for Definitive Treatment of Locally Advanced Cervical Cancer (LACC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06394297
• Other study ID #: VIBE
• Status: Recruiting
• Phase: N/A
• Start date: August 4, 2023
• Est. completion date: August 4, 2026

Study information

• Verified date: April 2024
• Source: Fundacao Champalimaud
• Contact: Maria Inês Antunes, MD
• Phone: +351210480200
• Email: ines.antunes[@]fundacaochampalimaud.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 4, 2026
• Est. primary completion date: August 4, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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

Locations

Country	Name	City	State
Portugal	Champalimaud Foundation	Lisboa

Sponsors (1)

Lead Sponsor	Collaborator
Fundacao Champalimaud

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dosimetric Feasibility of SBRT boost	Fulfillment of protocol dosimetrical endpoints and constraints	through study completion, an average of 3 year
Primary	reproducibility of SBRT boost	anatomical accuracy will be confirmed with image guided (CBCT) and online tracking will guarantee a limit of 2mm threshold	Accuracy of treatment delivery will be measured during the 15 minutes of treatment delivery time
Primary	Inter/intra fractional target motion	3D deviations recorded in CBCT images and electromagnetic recording	during the 15 minutes of treatment delivery time
Primary	Adverse Events	Treatment related side effects based on CTCAE V5.0	through study completion, an average of 3 years
Primary	Local control	Free from loco-regional relapse	through study completion, an average of 3 years
Secondary	Quality of life metrics	Change from baseline in European Organisation for Research and Treatment of Cancer quality of life questionnaire C30	through study completion, an average of 3 years
Secondary	Quality of life metrics	Change from baseline in European Organisation for Research and Treatment of Cancer quality of life questionnaire N24	through study completion, an average of 3 years
Secondary	Distant Relapse	Free from distant relapse	through study completion, an average of 3 years