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



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:40 - Any
Updated:4/2/2016
Start Date:July 2009
End Date:July 2028
Contact:Rachel Lei, BS
Email:rachel.lei@usoncology.com
Phone:303-418-7607

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A Phase III Randomized Study Comparing Intensity Modulated Planning Versus 3-Dimensional Planning for Accelerated Partial Breast Radiotherapy

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.


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.
We found this trial at
5
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Boulder, Colorado 80303
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Lakewood, Colorado 80228
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Littleton, Colorado 80120
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Thornton, Colorado 80260
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Thornton, CO
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