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

NCT06394297 | Recruiting

• 1 other identifier: VIBE
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Keywords

cervical cancer; Stereotactic body radiotherapy (SBRT); Stereotactic ablative body radiotherapy (SABR); Brachytherapy

Outcome Measures

Primary Outcomes (5)

• Dosimetric Feasibility of SBRT boost

  Fulfillment of protocol dosimetrical endpoints and constraints

  through study completion, an average of 3 year

• 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

• Inter/intra fractional target motion

  3D deviations recorded in CBCT images and electromagnetic recording

  during the 15 minutes of treatment delivery time

• Adverse Events

  Treatment related side effects based on CTCAE V5.0

  through study completion, an average of 3 years

• Local control

  Free from loco-regional relapse

  through study completion, an average of 3 years

Secondary Outcomes (3)

• Quality of life metrics

  through study completion, an average of 3 years

• Quality of life metrics

  through study completion, an average of 3 years

• Distant Relapse

  through study completion, an average of 3 years

Study Arms (1)

SBRT for cervical cancer

EXPERIMENTAL

SBRT to LACC following whole pelvis external beam radiotherapy

Radiation: SBRT

Interventions

SBRT RADIATION

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

Also known as: SABR

SBRT for cervical cancer

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacao Champalimaud: lead

Study Sites (1)

Champalimaud Foundation

Lisbon, 1400-038, Portugal

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Carlo Greco, MD

  Fundaçao Champalimaud

  STUDY DIRECTOR

Central Study Contacts

Maria Inês Antunes, MD

CONTACT

+351210480200; ines.antunes@fundacaochampalimaud.pt

Carlo Greco, MD

CONTACT

+351210480200; carlo.greco@fundacaochampalimaud.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: May 1, 2024
• Study Start: August 4, 2023
• Primary Completion: August 4, 2025
• Study Completion (Estimated): August 4, 2026
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)