Status:
UNKNOWN
Accelerated Partial Breast Radiotherapy With Either Mammosite or Intensity Modulated Radiotherapy
Lead Sponsor:
Rocky Mountain Cancer Centers
Collaborating Sponsors:
Charles Leonard, MD
Conditions:
Breast Cancer
Eligibility:
All Genders
40+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- Be pregnant or breast-feeding
- Have collagen-vascular disease
- Inadequate surgical margins (\< 2 mm)
- Patients with malignant/suspicious calcifications
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2024
Estimated Enrollment :
291 Patients enrolled
Trial Details
Trial ID
NCT01185145
Start Date
February 1 2004
End Date
August 1 2024
Last Update
July 11 2013
Active Locations (6)
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1
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, United States, 80012
2
Rocky Mountain Cancer Centers - Boulder
Boulder, Colorado, United States, 80303
3
Rocky Mountain Cancer Centers - Midtown
Denver, Colorado, United States, 80128
4
Rocky Mountain Cancer Centers - Littleton
Littleton, Colorado, United States, 80120