A Phase III Randomized Study Comparing Intensity Modulated Planning Versus 3-Dimensional Planning for Accelerated Partial Breast Radiotherapy
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 660
- Locations
- 5
- Primary Endpoint
- Prevalence of breast pain after Accelerated Partial Breast Radiotherapy (APBI)
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically confirmed disease (AJC Classification): Tis, T1, T2 (≤ 3.0 cm), N0, M
- •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.
- •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.
Arms & Interventions
IMRT
Intensity modulated radiotherapy, 38.5 Gy, 10 fractions over 5 days
Intervention: accelerated partial breast irradiation - IMRT planning (Radiation)
3D-CRT
Three dimensional conformal external radiotherapy, 38.5 Gy, 10 fractions over 5 days
Intervention: accelerated partial breast irradiation - 3D-conformal planning (Radiation)
Outcomes
Primary Outcomes
Prevalence of breast pain after Accelerated Partial Breast Radiotherapy (APBI)
Time Frame: 5 years
Assessment by both treating investigators and by subjective patient outcomes questionnaires filled out at each follow-up visit
Prevalence of chest wall pain after Accelerated Partial Breast Radiotherapy (APBI)
Time Frame: 2-5 years
Assessment by both treating investigators and by subjective patient outcomes questionnaires filled out at each follow-up visit
Secondary Outcomes
- Dosimetric comparison(5-10 days)
- Acute skin reactions(6 months)
- Ipsilateral breast event(5-15 years)
- Cause specific survival(5-15 years)
- Cosmetic outcomes after APBI(2-5 years)
- Disease free survival(5-15 years)
- Overall survival(5-15 years)