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

April 30, 2024 updated by: Inês Antunes, Fundacao Champalimaud

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SBRT for cervical cancer
SBRT to LACC following whole pelvis external beam radiotherapy
Radiation: SBRT
SBRT to reproduce HDR BT dose distribution in non-operated patients LACC
Other Names:
  • SABR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inter/intra fractional target motion
Time Frame: during the 15 minutes of treatment delivery time
3D deviations recorded in CBCT images and electromagnetic recording
during the 15 minutes of treatment delivery time
Dosimetric Feasibility of SBRT boost
Time Frame: through study completion, an average of 3 year
Fulfillment of protocol dosimetrical endpoints and constraints
through study completion, an average of 3 year
reproducibility of SBRT boost
Time Frame: 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
Accuracy of treatment delivery will be measured during the 15 minutes of treatment delivery time
Adverse Events
Time Frame: through study completion, an average of 3 years
Treatment related side effects based on CTCAE V5.0
through study completion, an average of 3 years
Local control
Time Frame: through study completion, an average of 3 years
Free from loco-regional relapse
through study completion, an average of 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life metrics
Time Frame: through study completion, an average of 3 years
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
Quality of life metrics
Time Frame: 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
through study completion, an average of 3 years
Distant Relapse
Time Frame: through study completion, an average of 3 years
Free from distant relapse
through study completion, an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacao Champalimaud

Investigators

  • Study Director: Carlo Greco, MD, Fundacao Champalimaud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2023

Primary Completion (Estimated)

August 4, 2025

Study Completion (Estimated)

August 4, 2026

Study Registration Dates

First Submitted

January 10, 2024

First Submitted That Met QC Criteria

April 30, 2024

First Posted (Actual)

May 1, 2024

Study Record Updates

Last Update Posted (Actual)

May 1, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIBE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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