At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed early-stage breast cancer (Tis, T1, T2 ≤3.0 cm, N0, M0)
- ✓Negative surgical margins of at least 0.2 cm after final surgery
- ✓Successful placement of non-migrating fiducial markers for image-guided radiotherapy
- ✓PTV to ipsilateral breast ratio of 25% or less
- ✕Pregnancy or breast-feeding
- ✕Collagen-vascular disease
- ✕Inadequate surgical margins (less than 0.2 cm) after final surgery
- ✕Persistent malignant or suspicious micro-calcifications
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT01185132Phase 3RecruitingUpdate OverdueUpdated 144mo ago · Completion was 96mo agoA Phase III Randomized Study Comparing Intensity Modulated Planning Versus 3-Dimensional Planning for Accelerated Partial Breast Radiotherapy
In Brief
A Phase 3 clinical trial evaluating accelerated partial breast irradiation - 3D-conformal planning and accelerated partial breast irradiation - IMRT planning for Breast Cancer. Currently recruiting, targeting 660 participants across 5 sites.
Signals
Detailed Summary
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.
Study Details
Timeline
Interventions
38.5 Gy, 10 fractions over 5 days
38.5 Gy, 10 fractions over 5 days