Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005983
Status:
TERMINATED
Last Update Posted:
2013-01-24
First Post:
2000-07-05
Brief Title:
S9927 Radiation Therapy After Surgery Chemotherapy andor Hormone Therapy in Stage II Breast Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Randomized Trial of Post-Mastectomy Radiotherapy in Stage II Breast Cancer in Women With One to Three Positive Axillary Nodes Phase III
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
due to lack of accrual
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 whether mastectomy chemotherapy andor hormone therapy are more effective with or without radiation therapy in treating breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of mastectomy chemotherapy andor hormone therapy with or without radiation therapy in treating women who have stage II breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of mastectomy chemotherapy andor hormone therapy with or without radiation therapy in treating women who have stage II breast cancer
Detailed Description:
OBJECTIVES
Compare overall and disease-free survival in women with stage II breast cancer with one to three positive nodes treated with radiotherapy vs observation only after mastectomy and adjuvant chemotherapy andor hormonal therapy
Compare local regional control in patients treated with these regimens
Assess the potential toxic effects of radiotherapy in this patient population
OUTLINE This is a randomized multicenter study Patients are stratified according to prior systemic hormonal therapy chemotherapy with or without hormonal therapy vs hormonal therapy alone prior taxane exposure yes vs no and duration of chemotherapy no chemotherapy vs less than 3 months vs 3-5 months vs 6 months or more Patients are randomized to one of two treatment arms
Arm I Patients undergo radiotherapy 5 days a week for 5 weeks
Arm II Patients are observed for disease progression Patients are followed every 6 months for 2 years and then annually for 15 years
PROJECTED ACCRUAL A total of 2500 patients 1250 per treatment arm will be accrued for this study within 5 years
Compare overall and disease-free survival in women with stage II breast cancer with one to three positive nodes treated with radiotherapy vs observation only after mastectomy and adjuvant chemotherapy andor hormonal therapy
Compare local regional control in patients treated with these regimens
Assess the potential toxic effects of radiotherapy in this patient population
OUTLINE This is a randomized multicenter study Patients are stratified according to prior systemic hormonal therapy chemotherapy with or without hormonal therapy vs hormonal therapy alone prior taxane exposure yes vs no and duration of chemotherapy no chemotherapy vs less than 3 months vs 3-5 months vs 6 months or more Patients are randomized to one of two treatment arms
Arm I Patients undergo radiotherapy 5 days a week for 5 weeks
Arm II Patients are observed for disease progression Patients are followed every 6 months for 2 years and then annually for 15 years
PROJECTED ACCRUAL A total of 2500 patients 1250 per treatment arm will be accrued for this study within 5 years
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 |
|---|---|---|---|
| RTOG-9915 | OTHER | RTOG | httpsreporternihgovquickSearchU10CA032102 |
| S9927 | OTHER | None | None |
| U10CA032102 | NIH | None | None |
| S9927 | OTHER | None | None |
| CAN-NCIC-MA25 | OTHER | None | None |
| CLB-49910 | OTHER | None | None |
| S9927 | OTHER | None | None |
| S9927 | OTHER | None | None |
| S9927 | OTHER | None | None |