Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy
Purpose
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.
Condition
- Breast Cancer
Eligibility
- Eligible Ages
- Over 40 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Histologically confirmed disease (AJC Classification): Tis, T1, T2 (≤ 3.0 cm), N0, M0. - Microscopic multifocal disease is only allowed when the entire span of identified disease measures 3.0 cm or less. - Negative surgical margins ( ≥ 0.2 cm) after final surgery. - Subjects with infiltrating lobular histologies or high nuclear grade DCIS will be required to have breast MRI scanning as part of the initial staging to verify localized disease. - Subjects with DCIS will be included in the study only if they had an MRI prior to lumpectomy. - Findings on MRI scanning revealing relevant suspicion of disease outside of planned lumpectomy volume should be further evaluated by ultrasound and, if necessary biopsy, to exclude multicentric/multifocal disease. - Subjects with malignant calcifications on mammography will be required to have repeat mammography after surgery to ensure removal of all malignant calcifications. - Willing to complete additional screening requirements and meet eligibility criteria as defined in protocol Sec. 4.4. - Successful placement of fiducial markers for IGRT requiring nonmigrating fiducials. - PTV to ipsilateral breast ratio (IBR) ≤ 25 %. - Radiotherapy anticipated to begin within 10 weeks of lumpectomy or re-excision of margins.
Exclusion Criteria
- Pregnancy or breast-feeding. - Have collagen-vascular disease. - Inadequate surgical margins ( < 0.2 cm) after final surgery. - Subjects with persistent malignant/suspicious micro-calcifications. - Gross multifocal disease and microscopic disease greater than 3.0 cm.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental IMRT |
Intensity modulated radiotherapy, 38.5 Gy, 10 fractions over 5 days |
|
|
Active Comparator 3D-CRT |
Three dimensional conformal external radiotherapy, 38.5 Gy, 10 fractions over 5 days |
|
Recruiting Locations
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado 80012
Aurora, Colorado 80012
Rocky Mountain Cancer Centers - Boulder
Boulder, Colorado 80303
Boulder, Colorado 80303
Rocky Mountain Cancer Centers - Lakewood
Lakewood, Colorado 80228
Lakewood, Colorado 80228
Rocky Mountain Cancer Centers - Littleton
Littleton, Colorado 80120
Littleton, Colorado 80120
Rocky Mountain Cancer Centers - Thornton
Thornton, Colorado 80260
Thornton, Colorado 80260
More Details
- NCT ID
- NCT01185132
- Status
- Recruiting
- Sponsor
- Rocky Mountain Cancer Centers