Accelerated Partial Breast Irradiation Using Intensity Modulated Radiotherapy Versus Whole Breast Irradiation

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

520 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2014-02-28

Brief Summary

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The aim of this Phase 3 randomised trial is to compare the efficacy and safety of whole breast radiotherapy to accelerated partial breast irradiation using intensity-modulated radiotherapy technique in selected early breast cancer patients after breast conserving surgery.

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Detailed Description

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The surgeons were requested to place clips at the borders of the surgical bed, using a minimum of four clips. The presence of surgical clips was a selection criterion to avoid geographic misses. Computed tomography (CT) scanning was performed using 0.3-cm thick-slices and a slice spacing of 0.3 cm.

In patients assigned to APBI arm, the clinical target volume (CTV) was drawn with a uniform 1-cm three-dimensional margin around the surgical clips. The CTV was limited to 3 mm from the skin surface and 3 mm from the lung-chest wall interface. A second uniform, three-dimensional 1-cm margin was added to the CTV to obtain the planning target volume (PTV). The PTV was allowed to extend 4 mm inside the ipsilateral lung and was limited to 3 mm from the skin. The ipsilateral and contralateral breast, ipsilateral and contralateral lung, heart, and spinal cord were contoured as organs at risk.

All the regions of interest were contoured according to the International Commission on Radiation Units and Measurements reports 50 and 62 recommendations. No respiratory control was used.

Concerning the experimental Arm (accelerated partial breast irradiation), a dose of 30 Gy in five fractions at 6 Gy/fraction was prescribed.

The following constraints were adopted for plan optimization: PTV coverage: 100% of PTV covered by 95% of the prescribed dose (V28.5 = 100%); maximal dose to PTV \<105% (31.5 Gy); minimal dose to PTV 28 Gy; uninvolved breast (i.e., ipsilateral breast without PTV): not \>50% covered by a dose of \>50% of the prescribed dose (V15 \<50%); ipsilateral lung: not \>20% covered by a dose \>10 Gy (V10\<20%); contralateral lung: not \>10% covered by a dose \>5 Gy (V5\<10%); contralateral breast: maximal dose \<1 Gy; heart: not \>10% covered by a dose \>3 Gy (V3 \<10%).

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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Whole breast irradiation (WBI)

Conventional whole breast irradiation (WBI)

Group Type ACTIVE_COMPARATOR

Whole breast irradiation (WBI)

Intervention Type RADIATION

Conventional whole breast irradiation (WBI)

Partial breast irradiation (APBI)

Accelerated partial breast irradiation (APBI)

Group Type EXPERIMENTAL

Accelerated partial breast irradiation (APBI)

Intervention Type RADIATION

Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)

Interventions

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Accelerated partial breast irradiation (APBI)

Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)

Intervention Type RADIATION

Whole breast irradiation (WBI)

Conventional whole breast irradiation (WBI)

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Age at presentation \>40 y
* Tumor size \<25 mm
* Wide excision or quadrantectomy with clear margins (\>5 mm)
* Clips placed in tumor bed
* Full informed consent from patient

Exclusion Criteria

* Cardiac dysfunction
* Forced expiratory volume in 1 second (FEV1) \<1 L/m
* Extensive intraductal carcinoma
* Multifocal cancer
* Psychiatric problems
* Recurrent breast cancer

Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No