Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06394258
Status:
COMPLETED
Last Update Posted:
2024-05-01
First Post:
2024-01-10
Brief Title:
POSE - POs Surgery Endometrial Cancer
Sponsor:
Fundacao Champalimaud
Organization:
Fundacao Champalimaud
Study Overview
Official Title:
POSE POs Surgery Endometrial Cancer - Phase III Study to Access SBRT as a Replacement for Brachytherapy in Intermediate and High Risk in Endometrial Cancer
Status:
COMPLETED
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:
POSE
Brief Summary:
This phase III feasibility study of hypo-fractionated image-guided Volumetric Modulated Arc Therapy VMAT Stereotactic Body Radiotherapy SBRT to the vaginal cuff in intermedium and high risk endometrial cancer The primary endpoints are SBRT feasibility and dosimetrical reproducibility to HDR brachytherapy interintra-fractional target motion assessment and toxicity rates Secondary endpoints are quality of life measures local control disease free survival and overall survival
Detailed Description:
This phase III feasibility study of hypo-fractionated image-guided Volumetric Modulated Arc Therapy VMAT Stereotactic Body Radiotherapy SBRT to the vaginal cuff aims to reproduce adjuvant High Dose Rate HDR brachytherapy dose distributions in patients operated for intermediate and high risk endometrial carcinoma The study will employ devices to accurately reproduce pelvic anatomy and mitigate target motion and will make use of real-time on-line tracking Eligible patients will receive three SBRT sessions to a prescription dose of 7 Gy to the vaginal cuff with 4 to 7 days interval SBRT will start within 4 to 8 weeks post-hysterectomy The study will enroll a total of 30 patients After treatment patients will be followed-up at 3 months - 6 weeks at 6 - 6 weeks and every 6 months - 6 weeks thereafter for a total of 2 years The duration of accrual in the study will be up to 3 years Toxicity and outcome will be compared to published data on the standard modality of care HDR brachytherapy Patients quality of life measures will be collected with validated questionnaires at the baseline and during follow up Recurrence rates and survival 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