Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00103181
Status:
COMPLETED
Last Update Posted:
2022-04-14
First Post:
2005-02-07
Brief Title:
Radiation Therapy WBI Versus PBI in Treating Women Who Have Undergone Surgery For Ductal Carcinoma In Situ or Stage I or Stage II Breast Cancer
Sponsor:
NSABP Foundation Inc
Organization:
NSABP Foundation Inc
Study Overview
Official Title:
A Randomized Phase III Study of Conventional Whole Breast Irradiation WBI Versus Partial Breast Irradiation PBI for Women With Stage 0 I or II Breast Cancer
Status:
COMPLETED
Status Verified Date:
2022-04
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 kill tumor cells Giving radiation therapy in different ways may kill any tumor cells that remain after surgery It is not yet known whether whole breast radiation therapy is more effective than partial breast radiation therapy in treating breast cancer
PURPOSE This randomized phase III trial is studying whole breast radiation therapy to see how well it works compared to partial breast radiation therapy in treating women who have undergone surgery for ductal carcinoma in situ or stage I or stage II breast cancer
PURPOSE This randomized phase III trial is studying whole breast radiation therapy to see how well it works compared to partial breast radiation therapy in treating women who have undergone surgery for ductal carcinoma in situ or stage I or stage II breast cancer
Detailed Description:
OBJECTIVES
Primary
Compare local tumor control in women with ductal carcinoma in situ or stage I or II breast cancer treated with adjuvant whole breast vs partial breast irradiation following lumpectomy
Secondary
Compare overall survival recurrence-free survival and distant disease-free survival in patients treated with these regimens
Compare the cosmetic result in patients treated with these regimens
Compare fatigue and treatment-related symptoms in patients treated with these regimens
Compare perceived convenience of care in patients treated with these regimens
Compare acute and late toxic effects of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to disease stage ductal carcinoma in situ DCIS only vs invasive and node negative vs invasive with 1-3 positive nodes menopausal status premenopausal vs postmenopausal hormone receptor status estrogen receptor ER-positive andor progesterone receptor PR-positive vs ER-negative and PR-negative intention to receive chemotherapy yes vs no Patients are randomized to 1 of 2 treatment arms Patients who are 50 years of age and over with DCIS regardless of hormone receptor status AND patients with invasive breast cancer meeting all of the following criteria 50 years of age node-negative and hormone-receptor positive status will not be enrolled in study after 12302006
Group 1 Patients undergo whole-breast irradiation WBI once daily 5 days a week for 5-7 weeks
Group 2 Patients undergo partial-breast irradiation PBI twice daily on 5 days over a period of 5-10 days This may be delivered by multi-catheter brachytherapy single-entry intracavitary brachytherapy or 3-D conformal radiotherapy
Patients in both arms may receive adjuvant chemotherapy at least 2 weeks prior to initiation of WBI OR at least 2 weeks after completion of PBI at the discretion of the treating physician Patients with ER-positive or PR-positive tumors may also receive hormonal therapy beginning 3-12 weeks after completion of adjuvant chemotherapy or before during or after completion of WBI or PBI for patients not receiving adjuvant chemotherapy and continuing for at least 5 years
After completion of study treatment patients are followed at 1 and 6 months every 6 months for 45 years and then annually thereafter
PROJECTED ACCRUAL A total of 4300 patients 2150 per treatment arm will be accrued for this study within 46 years Note Accrual closed on April 16 2013 following approval of the Data Monitoring Committee to reduce the sample size from 4300 to 4214 patients
Primary
Compare local tumor control in women with ductal carcinoma in situ or stage I or II breast cancer treated with adjuvant whole breast vs partial breast irradiation following lumpectomy
Secondary
Compare overall survival recurrence-free survival and distant disease-free survival in patients treated with these regimens
Compare the cosmetic result in patients treated with these regimens
Compare fatigue and treatment-related symptoms in patients treated with these regimens
Compare perceived convenience of care in patients treated with these regimens
Compare acute and late toxic effects of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to disease stage ductal carcinoma in situ DCIS only vs invasive and node negative vs invasive with 1-3 positive nodes menopausal status premenopausal vs postmenopausal hormone receptor status estrogen receptor ER-positive andor progesterone receptor PR-positive vs ER-negative and PR-negative intention to receive chemotherapy yes vs no Patients are randomized to 1 of 2 treatment arms Patients who are 50 years of age and over with DCIS regardless of hormone receptor status AND patients with invasive breast cancer meeting all of the following criteria 50 years of age node-negative and hormone-receptor positive status will not be enrolled in study after 12302006
Group 1 Patients undergo whole-breast irradiation WBI once daily 5 days a week for 5-7 weeks
Group 2 Patients undergo partial-breast irradiation PBI twice daily on 5 days over a period of 5-10 days This may be delivered by multi-catheter brachytherapy single-entry intracavitary brachytherapy or 3-D conformal radiotherapy
Patients in both arms may receive adjuvant chemotherapy at least 2 weeks prior to initiation of WBI OR at least 2 weeks after completion of PBI at the discretion of the treating physician Patients with ER-positive or PR-positive tumors may also receive hormonal therapy beginning 3-12 weeks after completion of adjuvant chemotherapy or before during or after completion of WBI or PBI for patients not receiving adjuvant chemotherapy and continuing for at least 5 years
After completion of study treatment patients are followed at 1 and 6 months every 6 months for 45 years and then annually thereafter
PROJECTED ACCRUAL A total of 4300 patients 2150 per treatment arm will be accrued for this study within 46 years Note Accrual closed on April 16 2013 following approval of the Data Monitoring Committee to reduce the sample size from 4300 to 4214 patients
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-2009-00698 | REGISTRY | CTRP Clinical Trials Reporting Program | None |
| NSABP-B-39 | None | None | None |
| RTOG-0413 | None | None | None |
| SWOG-NSABP-B-39 | None | None | None |