Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy

  • STATUS
    Recruiting
  • participants needed
    660
  • sponsor
    Rocky Mountain Cancer Centers
Updated on 8 November 2020
lumpectomy
ductal carcinoma in situ
breast cancer staging
mammogram
magnetic resonance imaging of breast
partial breast irradiation

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.

Details
Condition Breast Cancer
Treatment accelerated partial breast irradiation - 3D-conformal planning, accelerated partial breast irradiation - IMRT planning
Clinical Study IdentifierNCT01185132
SponsorRocky Mountain Cancer Centers
Last Modified on8 November 2020

Eligibility

Yes No Not Sure

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
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