Accelerated Partial Breast Radiotherapy With Either Mammosite or Intensity Modulated Radiotherapy
Phase 2
- Conditions
- Breast Cancer
- Registration Number
- NCT01185145
- Lead Sponsor
- Rocky Mountain Cancer Centers
- Brief Summary
Accelerated Partial Breast Irradiation by Mammosite and intensity modulated radiotherapy is safe and effective in patients with early stage breast cancer resected by lumpectomy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 291
Inclusion Criteria
- Be a Tis, T1, N0, M0 AJC Classification
- Have negative surgical margins (> or = 2 mm) after final surgery
- Should have adequate skin spacing between balloon surface and surface the skin (> 7 mm)*
- Patients with infiltrating lobular histologies should have breast MRI scanning as part of the initial staging to verify localized T1, or Tis disease
- Multifocal findings (define as 2 or more breast quadrants) on MRI scanning should be further evaluated by ultrasound and, if necessary biopsy, to exclude multiquadrant disease.
Exclusion Criteria
- Be pregnant or breast-feeding
- Have collagen-vascular disease
- Inadequate surgical margins (< 2 mm)
- Patients with malignant/suspicious calcifications
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Overall Survival 2-15 years Ipsilateral breast failure 2-15 years Disease free survival 2-15 years Cause specific survival 2-15 years
- Secondary Outcome Measures
Name Time Method Serious Adverse device-related Events 2-5 years
Trial Locations
- Locations (6)
Rocky Mountain Cancer Centers - Aurora
🇺🇸Aurora, Colorado, United States
Rocky Mountain Cancer Centers - Boulder
🇺🇸Boulder, Colorado, United States
Rocky Mountain Cancer Centers - Midtown
🇺🇸Denver, Colorado, United States
Rocky Mountain Cancer Centers - Littleton
🇺🇸Littleton, Colorado, United States
Rocky Mountain Cancer Centers - Sky Ridge
🇺🇸Lone Tree, Colorado, United States
Rocky Mountain Cancer Centers - Thornton
🇺🇸Thornton, Colorado, United States
Rocky Mountain Cancer Centers - Aurora🇺🇸Aurora, Colorado, United States