Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06394297
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-01-10
Brief Title:
VIBE - Virtual Image Guided Brachytherapy Emulation for Locally Advanced Cervical Cancer LACC
Sponsor:
Fundacao Champalimaud
Organization:
Fundacao Champalimaud
Study Overview
Official Title:
A Phase III Study for Image Guided Stereotactic Body Radiation Therapy Boost for Definitive Treatment of Locally Advanced Cervical Cancer LACC
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIBE
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 III 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None