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
- Conditions
- Breast Cancer
- Registration Number
- NCT00103181
- Lead Sponsor
- NSABP Foundation Inc
- 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.
- 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 and/or 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 12/30/2006.)
* 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 4.5 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 4,300 patients (2,150 per treatment arm) will be accrued for this study within 4.6 years. Note: Accrual closed on April 16, 2013, following approval of the Data Monitoring Committee to reduce the sample size from 4,300 to 4,214 patients.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 4216
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method In-breast tumor recurrence (IBTR) every 6 months for 5 years; annually thereafter for up to 10 years
- Secondary Outcome Measures
Name Time Method Recurrence-free survival time from randomization to recurrence assessed every 6 months for 5 years and annually thereafter for up to 10 years Quality of life and patient-reported cosmesis by Breast Cancer Treatment Outcome Scale, MOS SF-36 Vitality, Convenience of Care scale, and symptoms measured at baseline, and 1 and 6 months and 1, 2, and 3 years after completion of study treatment Overall survival time from randomization to death due to any cause assessed up to 15 years Distant disease-free survival time from randomization to event occurrence assessed every 6 months for 5 years and annually thereafter for up to 10 years Toxicity as assessed by adverse events during treatment at end of RT, and 4 weeks, 6 months, 12 months; every 6 months for years 2 through 5; and annually thereafter for up to 10 years
Related Research Topics
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Trial Locations
- Locations (387)
UAB Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Arizona Center for Cancer Care - Peoria
🇺🇸Peoria, Arizona, United States
Arizona Oncology Services Foundation
🇺🇸Phoenix, Arizona, United States
Arizona Breast Cancer Specialists
🇺🇸Scottsdale, Arizona, United States
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Auburn Radiation Oncology
🇺🇸Auburn, California, United States
Alta Bates Summit Comprehensive Cancer Center
🇺🇸Berkeley, California, United States
Peninsula Medical Center
🇺🇸Burlingame, California, United States
Radiation Oncology Centers - Cameron Park
🇺🇸Cameron Park, California, United States
Scroll for more (377 remaining)UAB Comprehensive Cancer Center🇺🇸Birmingham, Alabama, United States