Radiation Therapy in Treating Women Who Have Undergone Surgery for Early-Stage Invasive Breast Cancer
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ClinicalTrials.gov Identifier: NCT00005957 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Results First Posted : June 15, 2016
Last Update Posted : August 21, 2023
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Tracking Information | |||||||||||||||||||
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First Submitted Date ICMJE | July 5, 2000 | ||||||||||||||||||
First Posted Date ICMJE | January 27, 2003 | ||||||||||||||||||
Results First Submitted Date ICMJE | April 5, 2016 | ||||||||||||||||||
Results First Posted Date ICMJE | June 15, 2016 | ||||||||||||||||||
Last Update Posted Date | August 21, 2023 | ||||||||||||||||||
Actual Study Start Date ICMJE | March 9, 2000 | ||||||||||||||||||
Actual Primary Completion Date | November 20, 2014 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Current Primary Outcome Measures ICMJE |
Overall Survival [ Time Frame: 10 years ] Duration of study
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Original Primary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||
Change History | |||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
Disease-free Survival [ Time Frame: 10 years ] Disease-free survival (including locoregional and distant disease)
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Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Descriptive Information | |||||||||||||||||||
Brief Title ICMJE | Radiation Therapy in Treating Women Who Have Undergone Surgery for Early-Stage Invasive Breast Cancer | ||||||||||||||||||
Official Title ICMJE | A Phase III Study of Regional Radiation Therapy in Early Breast Cancer | ||||||||||||||||||
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. |
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Detailed Description | OBJECTIVES:
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
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 (i.e., 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 1,822 patients will be accrued for this study within approximately 4 years. |
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Study Type ICMJE | Interventional | ||||||||||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Breast Cancer | ||||||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||||||||
Actual Enrollment ICMJE |
1832 | ||||||||||||||||||
Original Enrollment ICMJE | Not Provided | ||||||||||||||||||
Actual Study Completion Date ICMJE | April 19, 2017 | ||||||||||||||||||
Actual Primary Completion Date | November 20, 2014 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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Sex/Gender ICMJE |
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Ages ICMJE | 16 Years to 120 Years (Child, Adult, Older Adult) | ||||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||
Listed Location Countries ICMJE | Canada | ||||||||||||||||||
Removed Location Countries | United States | ||||||||||||||||||
Administrative Information | |||||||||||||||||||
NCT Number ICMJE | NCT00005957 | ||||||||||||||||||
Other Study ID Numbers ICMJE | MA20 CAN-NCIC-MA20 NSABP-CAN-NCIC-MA20 ( Other Identifier: NSABP ) NCCTG-CAN-NCIC-MA20 ( Other Identifier: NCCTG ) RTOG-CAN-NCIC-MA20 ( Other Identifier: RTOG ) SWOG-CAN-NCIC-MA20 ( Other Identifier: SWOG ) TROG-CAN-NCIC-MA20 ( Other Identifier: TROG ) CDR0000067938 ( Other Identifier: PDQ ) |
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Has Data Monitoring Committee | Yes | ||||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Canadian Cancer Trials Group ( NCIC Clinical Trials Group ) | ||||||||||||||||||
Original Responsible Party | Not Provided | ||||||||||||||||||
Current Study Sponsor ICMJE | NCIC Clinical Trials Group | ||||||||||||||||||
Original Study Sponsor ICMJE | Canadian Cancer Trials Group | ||||||||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Canadian Cancer Trials Group | ||||||||||||||||||
Verification Date | March 2020 | ||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |