Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy
Recruiting now · Phase 3
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT01185132
- Run by
- Rocky Mountain Cancer Centers
- People needed
- 660
- Starts
- 2009-07-01
- Expected to finish
- 2028-07-01
- Last updated by the study team
- 2014-06-26
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Rocky Mountain Cancer Centers - Aurora — Aurora, Colorado, United States (enrolling)
- Rocky Mountain Cancer Centers - Boulder — Boulder, Colorado, United States (enrolling)
- Rocky Mountain Cancer Centers - Lakewood — Lakewood, Colorado, United States (enrolling)
- Rocky Mountain Cancer Centers - Littleton — Littleton, Colorado, United States (enrolling)
- Rocky Mountain Cancer Centers - Thornton — Thornton, Colorado, United States (enrolling)
Full record on ClinicalTrials.gov
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