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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

660 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2028-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IMRT

Intensity modulated radiotherapy, 38.5 Gy, 10 fractions over 5 days

Group Type EXPERIMENTAL

accelerated partial breast irradiation - IMRT planning

Intervention Type RADIATION

38.5 Gy, 10 fractions over 5 days

3D-CRT

Three dimensional conformal external radiotherapy, 38.5 Gy, 10 fractions over 5 days

Group Type ACTIVE_COMPARATOR

accelerated partial breast irradiation - 3D-conformal planning

Intervention Type RADIATION

38.5 Gy, 10 fractions over 5 days

Interventions

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accelerated partial breast irradiation - 3D-conformal planning

38.5 Gy, 10 fractions over 5 days

Intervention Type RADIATION

accelerated partial breast irradiation - IMRT planning

38.5 Gy, 10 fractions over 5 days

Intervention Type RADIATION

Other Intervention Names

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APBI EBRT APBI EBRT

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No