Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00301041
Status:
COMPLETED
Last Update Posted:
2013-08-21
First Post:
2006-03-08
Brief Title:
Radiation Therapy in Treating Women With Invasive Breast Cancer
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
The Relationship Between Plasma Transforming Growth Factor-beta 1 TGF-β and Fractionation in Radiotherapy for Breast Cancer A Randomized Study
Status:
COMPLETED
Status Verified Date:
2013-08
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:
RATIONALE Radiation therapy uses high-energy x-rays to kill tumor cells Giving radiation therapy in different ways may kill more tumor cells
PURPOSE This randomized clinical trial is studying the side effects and best way to give radiation therapy and to see how well it works in treating patients with invasive breast cancer
PURPOSE This randomized clinical trial is studying the side effects and best way to give radiation therapy and to see how well it works in treating patients with invasive breast cancer
Detailed Description:
OBJECTIVES
Primary
Compare the ratio between post- and pre-treatment plasma transforming growth factor-beta 1 TGF-β in women with invasive breast cancer undergoing hypofractionated radiotherapy vs standard-fractionated external-beam radiotherapy
Secondary
Establish longitudinal serum and plasma biorepository for retrospective evaluation of TGF-β and other biomarkers with special relevance to radiation response
Correlate pre-treatment plasma TGF-β levels with clinical fibrosis development
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms
Arm I hypofractionated radiotherapy Patients undergo external-beam radiotherapy once daily 5 days a week for up to 35 weeks 16 fractions total
Arm II standard fractionated radiotherapy Patients undergo radiotherapy as in arm I at a lower dose for up to 5 weeks 25 fractions total
After completion of study treatment patients are followed every 6 months for 2 years and then annually for 3 years
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study
Primary
Compare the ratio between post- and pre-treatment plasma transforming growth factor-beta 1 TGF-β in women with invasive breast cancer undergoing hypofractionated radiotherapy vs standard-fractionated external-beam radiotherapy
Secondary
Establish longitudinal serum and plasma biorepository for retrospective evaluation of TGF-β and other biomarkers with special relevance to radiation response
Correlate pre-treatment plasma TGF-β levels with clinical fibrosis development
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms
Arm I hypofractionated radiotherapy Patients undergo external-beam radiotherapy once daily 5 days a week for up to 35 weeks 16 fractions total
Arm II standard fractionated radiotherapy Patients undergo radiotherapy as in arm I at a lower dose for up to 5 weeks 25 fractions total
After completion of study treatment patients are followed every 6 months for 2 years and then annually for 3 years
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study
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