Status:
RECRUITING
Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy
Lead Sponsor:
Rocky Mountain Cancer Centers
Conditions:
Breast Cancer
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief 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 effe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
660 Patients enrolled
Trial Details
Trial ID
NCT01185132
Start Date
July 1 2009
End Date
July 1 2028
Last Update
June 26 2014
Active Locations (5)
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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 - Lakewood
Lakewood, Colorado, United States, 80228
4
Rocky Mountain Cancer Centers - Littleton
Littleton, Colorado, United States, 80120