Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005587
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2000-05-02
Brief Title:
Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer
Sponsor:
Medical Research Council
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Standardization of Breast Radiotherapy Trial B - A Randomized Comparison of Fractionation Regimens After Local Excision or Mastectomy in Women With Early Stage Breast Cancer
Status:
COMPLETED
Status Verified Date:
2001-07
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 damage tumor cells It is not yet known which regimen of radiation therapy is more effective following surgery for breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two regimens of radiation therapy following surgery in treating women who have early stage breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two regimens of radiation therapy following surgery in treating women who have early stage breast cancer
Detailed Description:
OBJECTIVES
Determine the benefits of radiotherapy schedules using fraction sizes larger than 20 Gy in terms of normal tissue responses local-regional tumor control quality of life and economic consequences in women prescribed postoperative radiotherapy for early stage breast cancer
OUTLINE This is a randomized multicenter study Patients are stratified according to center type of surgery mastectomy vs local excision and breast boost yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive radiotherapy 5 times a week for 5 weeks for a total dose of 50 Gy
Arm II Patients receive radiotherapy 5 times a week for 3 weeks for a total dose of 40 Gy
A breast boost is recommended in both arms for patients with microscopic evidence of invasive or in situ cancer at or within 1 mm of a resection margin These patients receive radiotherapy for 5 fractions in 1 week for a total boost dose of 10 Gy
Quality of life is assessed at baseline and then at 6 12 24 and 60 months
Patients are followed annually for up to 20 years
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 1840 patients 920 per arm will be accrued for this study
Determine the benefits of radiotherapy schedules using fraction sizes larger than 20 Gy in terms of normal tissue responses local-regional tumor control quality of life and economic consequences in women prescribed postoperative radiotherapy for early stage breast cancer
OUTLINE This is a randomized multicenter study Patients are stratified according to center type of surgery mastectomy vs local excision and breast boost yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive radiotherapy 5 times a week for 5 weeks for a total dose of 50 Gy
Arm II Patients receive radiotherapy 5 times a week for 3 weeks for a total dose of 40 Gy
A breast boost is recommended in both arms for patients with microscopic evidence of invasive or in situ cancer at or within 1 mm of a resection margin These patients receive radiotherapy for 5 fractions in 1 week for a total boost dose of 10 Gy
Quality of life is assessed at baseline and then at 6 12 24 and 60 months
Patients are followed annually for up to 20 years
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 1840 patients 920 per arm 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-99015 | None | None | None |
| STMG-STARTB | None | None | None |