Ignite Creation Date:
2024-10-25 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06559540
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Ultra-Hypofractionated vs Hypofractionated Radiation for Node-Positive Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
SWIFT RT Ultra-Hypofractionated vs Hypofractionated Radiation for Node-Positive Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SWIFT RT
Brief Summary:
In breast cancer patients with nodal involvement numerous studies have demonstrated that adjuvant radiation therapy reduces the risk of local recurrence regional recurrence and distant metastases in addition to improving survival The dose and fractionation for adjuvant breast radiation therapy has evolved over time as novel schedules have been compared to the current standard of care Hypofractionated radiation therapy 266 cGy per fraction x 15-16 fractions over 3 weeks has been shown to result in equivalent oncologic outcomes as well as equivalent acute and late toxicity when compared to standard fractionation 200 cGy per fraction x 25 fractions over 5 weeks Subsequently hypofractionated breast radiation has become the current standard of care
More recently ultra-hypofractionated breast radiation 520 cGy per fraction x 5 fractions over 1 week was shown in a randomized trial to be non-inferior to hypofractionated radiation when treating the breast after lumpectomy However the efficacy and toxicity of using ultra-hypofractionated radiation therapy when also treating the regional nodes has not been reported This is important as there is greater radiation exposure to several normal tissues such as the armshoulder brachial plexus normal lymphatics heart and lung when treating the regional nodes
In this randomized study the investigators aim to compare the tolerability and efficacy of ultra-hypofractionated breastchest wall and regional nodal radiation SWIFT RT against hypofractionated radiation RT The investigators will evaluate acute and late toxicity oncologic outcomes including local recurrence regional recurrence distant metastasis and overall survival cosmesis and patient-reported quality of life The investigators will collect blood samples for correlative studies of biomarkers of fibrosis and cardiac toxicity
More recently ultra-hypofractionated breast radiation 520 cGy per fraction x 5 fractions over 1 week was shown in a randomized trial to be non-inferior to hypofractionated radiation when treating the breast after lumpectomy However the efficacy and toxicity of using ultra-hypofractionated radiation therapy when also treating the regional nodes has not been reported This is important as there is greater radiation exposure to several normal tissues such as the armshoulder brachial plexus normal lymphatics heart and lung when treating the regional nodes
In this randomized study the investigators aim to compare the tolerability and efficacy of ultra-hypofractionated breastchest wall and regional nodal radiation SWIFT RT against hypofractionated radiation RT The investigators will evaluate acute and late toxicity oncologic outcomes including local recurrence regional recurrence distant metastasis and overall survival cosmesis and patient-reported quality of life The investigators will collect blood samples for correlative studies of biomarkers of fibrosis and cardiac toxicity
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None