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

Sponsor: Rocky Mountain Cancer Centers

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT01185132

Patient View

This clinical trial compares IMRT and 3D-conformal APBI for early-stage breast cancer post-lumpectomy. Eligible participants must have histologically confirmed disease, negative surgical margins, and meet specific imaging criteria. Both interventions involve 38.5 Gy radiation over 10 fractions in 5 days. Radiotherapy should start within 10 weeks post-surgery.

Patient Parameters

Program Overview

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.

Eligibility Criteria

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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