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

Breast Cancer Clinical Trial

Official title:

Randomised Phase 3 Trial Of Accelerated Partial Breast Irradiation Using Intensity Modulated Radiotherapy Versus Whole Breast Irradiation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02104895
• Other study ID #: APBI-IMRT-Florence
• Status: Active, not recruiting
• Phase: Phase 3
• First received: April 2, 2014
• Last updated: April 4, 2014
• Start date: March 2005

Study information

• Verified date: April 2014
• Source: Azienda Ospedaliero-Universitaria Careggi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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%).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 520
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Radiation:
• Accelerated partial breast irradiation (APBI)
Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)
• Whole breast irradiation (WBI)
Conventional whole breast irradiation (WBI)

Locations

Country	Name	City	State
Italy	Radiation Oncology Unit, Azienda Ospedaliero-Universitaria Careggi	Florence

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Careggi

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Livi L, Buonamici FB, Simontacchi G, Scotti V, Fambrini M, Compagnucci A, Paiar F, Scoccianti S, Pallotta S, Detti B, Agresti B, Talamonti C, Mangoni M, Bianchi S, Cataliotti L, Marrazzo L, Bucciolini M, Biti G. Accelerated partial breast irradiation with — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cosmesis	Patients and physicians-rated cosmesis	5 years	Yes
Primary	Ipsilateral breast tumor recurrence		5-year	No
Secondary	Safety	Acute and late skin toxicity. Heart and lung toxicity.	5 years	Yes