Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005957
Status:
COMPLETED
Last Update Posted:
2023-08-21
First Post:
2000-07-05
Brief Title:
Radiation Therapy in Treating Women Who Have Undergone Surgery for Early-Stage Invasive Breast Cancer
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase III Study of Regional Radiation Therapy in Early Breast Cancer
Status:
COMPLETED
Status Verified Date:
2020-03
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 Radiation to the tumor site and surrounding area may kill more tumor cells It is not yet known if radiation therapy to the breast alone following surgery is more effective than radiation therapy to the breast plus surrounding tissue in treating invasive breast cancer
PURPOSE This randomized phase III trial is studying radiation therapy to the breast alone to see how well it works compared to radiation therapy to the breast plus surrounding tissue in treating women who have undergone surgery for early-stage invasive breast cancer
PURPOSE This randomized phase III trial is studying radiation therapy to the breast alone to see how well it works compared to radiation therapy to the breast plus surrounding tissue in treating women who have undergone surgery for early-stage invasive breast cancer
Detailed Description:
OBJECTIVES
Compare the overall survival disease-free survival isolated local regional disease-free survival and distant disease-free survival in women with previously resected early stage invasive breast cancer treated with breast radiotherapy with or without regional radiotherapy
Compare the toxic effects of these regimens in these patients
Compare the quality of life of patients in certain participating centers treated with these regimens
Compare the cosmetic outcomes in patients in certain participating centers treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to number of positive nodes 0 vs 1-3 vs more than 3 number of axillary nodes removed 10 or equal to 10 type of chemotherapy anthracycline containing vs other vs none hormonal therapy yes vs no number of axillary lymph nodes excised and participating center Patients are randomized to one of two treatment arms
NOTE Patients with a negative sentinel node dissection with or without an axillary dissection will be stratified according to the total number of nodes removed
Arm I Patients undergo standard breast radiotherapy alone 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity
Arm II Patients undergo breast and regional radiotherapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity
Radiotherapy in both arms begins as soon as possible after randomization Radiotherapy must begin within 8 weeks after completion of adjuvant IV chemotherapy unless radiotherapy is administered concurrently with chemotherapy ie cyclophosphamide methotrexate and fluorouracil CMF or within 16 weeks after the last breast surgery for patients treated with hormonal therapy alone
Quality of life is assessed in patients in certain participating centers within 2 weeks prior to randomization during the last week of radiotherapy at 3 and 9 months after completion of radiotherapy and then annually until first distant disease recurrence
Cosmetic outcome is assessed in patients in certain participating centers within 2 weeks prior to randomization and then at 3 and 5 years after completion of radiotherapy or until first distant disease recurrence
Patients are followed at 3 6 and 9 months every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL Approximately 1822 patients will be accrued for this study within approximately 4 years
Compare the overall survival disease-free survival isolated local regional disease-free survival and distant disease-free survival in women with previously resected early stage invasive breast cancer treated with breast radiotherapy with or without regional radiotherapy
Compare the toxic effects of these regimens in these patients
Compare the quality of life of patients in certain participating centers treated with these regimens
Compare the cosmetic outcomes in patients in certain participating centers treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to number of positive nodes 0 vs 1-3 vs more than 3 number of axillary nodes removed 10 or equal to 10 type of chemotherapy anthracycline containing vs other vs none hormonal therapy yes vs no number of axillary lymph nodes excised and participating center Patients are randomized to one of two treatment arms
NOTE Patients with a negative sentinel node dissection with or without an axillary dissection will be stratified according to the total number of nodes removed
Arm I Patients undergo standard breast radiotherapy alone 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity
Arm II Patients undergo breast and regional radiotherapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity
Radiotherapy in both arms begins as soon as possible after randomization Radiotherapy must begin within 8 weeks after completion of adjuvant IV chemotherapy unless radiotherapy is administered concurrently with chemotherapy ie cyclophosphamide methotrexate and fluorouracil CMF or within 16 weeks after the last breast surgery for patients treated with hormonal therapy alone
Quality of life is assessed in patients in certain participating centers within 2 weeks prior to randomization during the last week of radiotherapy at 3 and 9 months after completion of radiotherapy and then annually until first distant disease recurrence
Cosmetic outcome is assessed in patients in certain participating centers within 2 weeks prior to randomization and then at 3 and 5 years after completion of radiotherapy or until first distant disease recurrence
Patients are followed at 3 6 and 9 months every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL Approximately 1822 patients will be accrued for this study within approximately 4 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CDR0000067938 | OTHER | PDQ | None |
| CAN-NCIC-MA20 | None | None | None |
| NSABP-CAN-NCIC-MA20 | OTHER | None | None |
| NCCTG-CAN-NCIC-MA20 | OTHER | None | None |
| RTOG-CAN-NCIC-MA20 | OTHER | None | None |
| SWOG-CAN-NCIC-MA20 | OTHER | None | None |
| TROG-CAN-NCIC-MA20 | OTHER | None | None |