Actively Recruiting
Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy
Led by Rocky Mountain Cancer Centers · Updated on 2014-06-26
660
Participants Needed
5
Research Sites
991 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In the setting of radiotherapy as part of breast-conservation therapy for patients with early stage breast cancer, the novel planning and delivery method of intensity modulated radiotherapy is an effective and safe alternative to the commonly-used standard 3D-conformal external beam radiotherapy, spares more normal breast and lung tissue, and may lead to improved clinical outcomes.
CONDITIONS
Official Title
Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed breast cancer (AJC Classification): Tis, T1, T2 (up to 3.0 cm), N0, M0
- Microscopic multifocal disease allowed if total size is 3.0 cm or less
- Negative surgical margins of at least 0.2 cm after final surgery
- Breast MRI required for infiltrating lobular histologies or high nuclear grade DCIS for staging
- MRI required prior to lumpectomy for subjects with DCIS
- Further evaluation by ultrasound or biopsy if MRI shows suspicious disease outside lumpectomy area
- Repeat mammography after surgery if malignant calcifications were present
- Willingness to complete additional screening and meet protocol eligibility requirements
- Successful placement of nonmigrating fiducial markers for image-guided radiation therapy
- Planning target volume to ipsilateral breast ratio (IBR) must be 25% or less
- Radiotherapy planned to start within 10 weeks after lumpectomy or re-excision
You will not qualify if you...
- Pregnancy or breastfeeding
- Collagen-vascular disease
- Inadequate surgical margins less than 0.2 cm after final surgery
- Persistent malignant or suspicious micro-calcifications
- Gross multifocal disease or microscopic disease larger than 3.0 cm
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, United States, 80012
Actively Recruiting
2
Rocky Mountain Cancer Centers - Boulder
Boulder, Colorado, United States, 80303
Actively Recruiting
3
Rocky Mountain Cancer Centers - Lakewood
Lakewood, Colorado, United States, 80228
Actively Recruiting
4
Rocky Mountain Cancer Centers - Littleton
Littleton, Colorado, United States, 80120
Actively Recruiting
5
Rocky Mountain Cancer Centers - Thornton
Thornton, Colorado, United States, 80260
Actively Recruiting
Research Team
R
Rachel Lei, BS
CONTACT
C
Charles Leonard, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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