Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006030
Status:
UNKNOWN
Last Update Posted:
2013-08-07
First Post:
2000-07-05
Brief Title:
Comparison of Four Different Treatment Regimens in Treating Women With Stage I Breast Cancer
Sponsor:
British Association of Surgical Oncology Breast Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Protocol of a Randomized Trial for the Management of Small Well-Differentiated and Special Type Carcinomas of the Breast
Status:
UNKNOWN
Status Verified Date:
2006-12
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Estrogen can stimulate the growth of breast cancer cells Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells Combining radiation therapy and tamoxifen with surgery may kill more tumor cells It is not yet known which treatment regimen is most effective for stage I breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of four different treatment regimens in treating women who have stage I breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of four different treatment regimens in treating women who have stage I breast cancer
Detailed Description:
OBJECTIVES I Compare the effectiveness of wide local excision alone versus wide local excision followed by radiotherapy with or without tamoxifen versus wide local excision plus tamoxifen in women with stage I breast cancer II Assess local occurrence in the treated breast regional recurrence distant recurrence death from breast cancer and occurrence of cancer in the opposite breast in these patients when treated with one of these regimens
OUTLINE This is a randomized study Patients are randomized to one of four treatment arms All patients undergo wide local excision of the tumor and axillary node dissection Arm I Patients undergo surgery only Arm II Patients undergo surgery followed by 25-35 radiotherapy treatments Arm III Patients undergo surgery plus oral tamoxifen daily for 5 years Arm IV Patients undergo surgery followed by 25-35 radiotherapy treatments and oral tamoxifen daily for five years Patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 1200 patients 300 per treatment arm will be accrued for this study
OUTLINE This is a randomized study Patients are randomized to one of four treatment arms All patients undergo wide local excision of the tumor and axillary node dissection Arm I Patients undergo surgery only Arm II Patients undergo surgery followed by 25-35 radiotherapy treatments Arm III Patients undergo surgery plus oral tamoxifen daily for 5 years Arm IV Patients undergo surgery followed by 25-35 radiotherapy treatments and oral tamoxifen daily for five years Patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 1200 patients 300 per treatment 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 |
|---|---|---|---|
| ISRCTN47734678 | REGISTRY | ISRCTN International Standard Randomised Controlled Trial Number Register | None |
| CDR0000068043 | REGISTRY | None | None |
| EU-20019 | None | None | None |