VIBE - Virtual Image Guided Brachytherapy Emulation for L... | NCT06394297

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

NCT06394297

Sponsor

Fundacao Champalimaud

Status

Recruiting

Last Update Posted

May 1, 2024Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Cervical Cancer

Interventions

SBRT

Countries

Portugal

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 4, 2023Actual

Primary Completion Date

Aug 4, 2025Estimated

Completion Date

Aug 4, 2026Estimated

First Submitted Date

Jan 10, 2024

First Submission Date that Met QC Criteria

Apr 30, 2024

First Posted Date

May 1, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 30, 2024

Last Update Posted Date

May 1, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SBRT for cervical cancer	Experimental	SBRT to LACC following whole pelvis external beam radiotherapy	Radiation: SBRT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SBRT	Radiation	SBRT to reproduce HDR BT dose distribution in non-operated patients LACC	SBRT for cervical cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
Quality of life metrics

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Maria Inês Antunes, MD	Contact	+351210480200		ines.antunes@fundacaochampalimaud.pt
Carlo Greco, MD	Contact	+351210480200		carlo.greco@fundacaochampalimaud.pt

Overall Officials

Name	Affiliation	Role
Carlo Greco, MD	Fundaçao Champalimaud	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Champalimaud Foundation	Recruiting	Lisbon		1400-038	Portugal

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002583	Uterine Cervical Neoplasms

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

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.