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

NCT01185132 · Rocky Mountain Cancer Centers
In plain English

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Official title
A Phase III Randomized Study Comparing Intensity Modulated Planning Versus 3-Dimensional Planning for Accelerated Partial Breast Radiotherapy
About this study
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.
Study design
Enrollment target: 660 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2009-07
Estimated completion: 2028-07
Last updated: 2014-06-26
Interventions
Radiation: accelerated partial breast irradiation - 3D-conformal planningRadiation: accelerated partial breast irradiation - IMRT planning
Primary outcomes
  • Prevalence of breast pain after Accelerated Partial Breast Radiotherapy (APBI) (5 years)
  • Prevalence of chest wall pain after Accelerated Partial Breast Radiotherapy (APBI) (2-5 years)
Sponsor
Rocky Mountain Cancer Centers · other
Contacts & investigators
ContactRachel Lei, BS · contact · rachel.lei@usoncology.com · 303-418-7607
ContactCharles Leonard, MD · contact · 303-730-4700
InvestigatorCharles Leonard, MD · principal_investigator, Rocky Mountain Cancer Centers
All locations (5)
Rocky Mountain Cancer Centers - AuroraRecruiting
Aurora, Colorado, United States
Rocky Mountain Cancer Centers - BoulderRecruiting
Boulder, Colorado, United States
Rocky Mountain Cancer Centers - LakewoodRecruiting
Lakewood, Colorado, United States
Rocky Mountain Cancer Centers - LittletonRecruiting
Littleton, Colorado, United States
Rocky Mountain Cancer Centers - ThorntonRecruiting
Thornton, Colorado, United States
Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy · TrialPath