Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107497
Status:
COMPLETED
Last Update Posted:
2019-02-27
First Post:
2005-04-05
Brief Title:
Radiation Therapy in Treating Women With Localized Breast Cancer
Sponsor:
Institute of Cancer Research United Kingdom
Organization:
Institute of Cancer Research United Kingdom
Study Overview
Official Title:
Prospective Randomised Clinical Trial Testing 57 Gy and 60 Gy Fractions of Whole Breast Radiotherapy in Terms of Late Normal Tissue Responses and Tumour Control - FAST
Status:
COMPLETED
Status Verified Date:
2019-02
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:
FAST
Brief Summary:
RATIONALE Radiation therapy uses high-energy x-rays to kill tumor cells Giving radiation therapy in different ways and giving it after surgery may kill any tumor cells that remain after surgery
PURPOSE This randomized clinical trial is studying radiation therapy to see how well it works in treating women with localized breast cancer
PURPOSE This randomized clinical trial is studying radiation therapy to see how well it works in treating women with localized breast cancer
Detailed Description:
OBJECTIVES
Compare late normal tissue effects of standard vs 2 different dose levels of hypofractionated adjuvant whole breast radiotherapy in terms of changes in photographic breast appearance in women with localized breast cancer who are at average or low risk of recurrence
Compare tumor control in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center Patients are randomized to 1 of 3 treatment arms
Arm I control Patients undergo standard radiotherapy 5 days a week for 5 weeks
Arm II Patients undergo hypofractional radiotherapy once a week for 5 weeks
Arm III Patients undergo hypofractional radiotherapy at a lower dose than arm II once a week for 5 weeks
After completion of study treatment patients are followed annually for 5-10 years
PROJECTED ACCRUAL A total of 900 patients 300 per treatment arm will be accrued for this study within 12 months
Compare late normal tissue effects of standard vs 2 different dose levels of hypofractionated adjuvant whole breast radiotherapy in terms of changes in photographic breast appearance in women with localized breast cancer who are at average or low risk of recurrence
Compare tumor control in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center Patients are randomized to 1 of 3 treatment arms
Arm I control Patients undergo standard radiotherapy 5 days a week for 5 weeks
Arm II Patients undergo hypofractional radiotherapy once a week for 5 weeks
Arm III Patients undergo hypofractional radiotherapy at a lower dose than arm II once a week for 5 weeks
After completion of study treatment patients are followed annually for 5-10 years
PROJECTED ACCRUAL A total of 900 patients 300 per treatment arm will be accrued for this study within 12 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ICR-04MRE0617 | OTHER_GRANT | UK MREC | None |