Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003857
Status:
COMPLETED
Last Update Posted:
2022-05-25
First Post:
1999-11-01
Brief Title:
Radiation Therapy With or Without Optional Tamoxifen in Treating Women With Ductal Carcinoma in Situ
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
Phase III Trial of Tamoxifen Alone vs Tamoxifen Plus Radiation Therapy for Good Risk Duct Carcinoma In-Situ DCIS of the Female Breast
Status:
COMPLETED
Status Verified Date:
2022-05
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 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 It is not yet known if radiation therapy is more effective than observation with or without tamoxifen in treating ductal carcinoma in situ
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy with that of observation with or without tamoxifen in treating women who have ductal carcinoma in situ
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy with that of observation with or without tamoxifen in treating women who have ductal carcinoma in situ
Detailed Description:
OBJECTIVES
Compare the efficacy of whole breast radiotherapy vs observation with or without optional tamoxifen in decreasing or delaying the appearance of local failure both invasive and in situ and preventing the need for mastectomy in women with good-risk ductal carcinoma in situ DCIS of the breast
Compare distant disease-free survival of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to age under 50 vs 50 and over final path margins negative vs 3-9 mm vs at least 10 mm mammographic size of primary no greater than 1 cm vs greater than 1 cm to 25 cm nuclei grade low vs intermediate and tamoxifen use yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo observation and may receive optional oral tamoxifen once daily at the discretion of the physician for 5 years
Arm II Beginning within 12 weeks after final surgery patients receive radiotherapy to the whole breast once daily 5 days a week for 35-55 weeks Patients may receive optional tamoxifen as in arm I
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 1790 patients will be accrued for this study within 6 years
Compare the efficacy of whole breast radiotherapy vs observation with or without optional tamoxifen in decreasing or delaying the appearance of local failure both invasive and in situ and preventing the need for mastectomy in women with good-risk ductal carcinoma in situ DCIS of the breast
Compare distant disease-free survival of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to age under 50 vs 50 and over final path margins negative vs 3-9 mm vs at least 10 mm mammographic size of primary no greater than 1 cm vs greater than 1 cm to 25 cm nuclei grade low vs intermediate and tamoxifen use yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo observation and may receive optional oral tamoxifen once daily at the discretion of the physician for 5 years
Arm II Beginning within 12 weeks after final surgery patients receive radiotherapy to the whole breast once daily 5 days a week for 35-55 weeks Patients may receive optional tamoxifen as in arm I
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 1790 patients will be accrued for this study within 6 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 |
|---|---|---|---|
| NCI-2011-02038 | REGISTRY | CTRP Clinical Trial Reporting Program | None |
| CDR0000067020 | None | None | None |
| CAN-NCIC-MA26 | None | None | None |
| CALGB-49801 | None | None | None |