Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06295744
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-02-28
Brief Title:
Outcomes and Cosmesis With Whole Breast Irradiation and Boost
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Patient-Reported Outcomes and Cosmesis Following Five Fraction Whole Breast Irradiation With Simultaneous Integrated Boost
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:
None
Brief Summary:
This study is being done to evaluate cosmetic patient-reported outcome measures PROMs and toxicities for women undergoing ultra-short whole breast irradiation WBI therapy with simultaneous integrated boost SIB 50 participants will be on study for up to 60 months
Detailed Description:
The study population will consist of 50 participants with non-metastatic early-stage invasive breast cancer or ductal carcinoma in situ DCIS Eligible patients will include those with a biopsy proven invasive breast cancer or DCIS greater than or equal to 18 years of age undergoing breast conserving surgery and adjuvant radiation therapy at UW Health with an indication for WBI with tumor bed boost Selection need for boost and radiation treatment field design and pre-tx imaging are at the discretion of the treating provider
Accrual will occur over 5 years at UW Health Participants will complete 5 treatment visits and 7 study visits over the course of approximately 55 years Research-related outcome measures - MD assessments eg cosmesis PROMs and AEs -- will be assessed prior to treatment start at the 6-week follow-up visit as well as at 12- 24- 36- 48- and 60-month follow-up visits Study participation ends after completion of the 60-month follow-up visit
Objective
To assess two-year cosmetic outcomes in patients treated with ultra-short WBI with a SIB
Secondary Objectives
To assess PROMs via BREAST-Q in patients treated with ultra-short WBI with SIB
To assess acute toxicities in patients treated with ultra-short WBI with SIB
To assess late toxicities in patients treated with ultra-short WBI with SIB
To assess ipsilateral breast tumor recurrence in patients treated with ultra-short WBI with SIB
To assess overall survival OS in patients treated with ultra-short WBI with SIB
Accrual will occur over 5 years at UW Health Participants will complete 5 treatment visits and 7 study visits over the course of approximately 55 years Research-related outcome measures - MD assessments eg cosmesis PROMs and AEs -- will be assessed prior to treatment start at the 6-week follow-up visit as well as at 12- 24- 36- 48- and 60-month follow-up visits Study participation ends after completion of the 60-month follow-up visit
Objective
To assess two-year cosmetic outcomes in patients treated with ultra-short WBI with a SIB
Secondary Objectives
To assess PROMs via BREAST-Q in patients treated with ultra-short WBI with SIB
To assess acute toxicities in patients treated with ultra-short WBI with SIB
To assess late toxicities in patients treated with ultra-short WBI with SIB
To assess ipsilateral breast tumor recurrence in patients treated with ultra-short WBI with SIB
To assess overall survival OS in patients treated with ultra-short WBI with SIB
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Protocol Version 252024 | OTHER | None | None |
| A533300 | OTHER | None | None |
| UW23114 | REGISTRY | UWCCC OnCore ID | None |