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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Lorenzo Livi, Azienda Ospedaliero-Universitaria Careggi
ClinicalTrials.gov Identifier:
NCT02104895
First received: April 2, 2014
Last updated: April 4, 2014
Last verified: April 2014

April 2, 2014
April 4, 2014
March 2005
February 2014   (final data collection date for primary outcome measure)
Ipsilateral breast tumor recurrence [ Time Frame: 5-year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02104895 on ClinicalTrials.gov Archive Site
Safety [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Acute and late skin toxicity. Heart and lung toxicity.
Same as current
Cosmesis [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Patients and physicians-rated cosmesis
Same as current
 
Accelerated Partial Breast Irradiation Using Intensity Modulated Radiotherapy Versus Whole Breast Irradiation
Randomised Phase 3 Trial Of Accelerated Partial Breast Irradiation Using Intensity Modulated Radiotherapy Versus Whole Breast Irradiation

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.

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%).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Radiation: Accelerated partial breast irradiation (APBI)
    Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)
  • Radiation: Whole breast irradiation (WBI)
    Conventional whole breast irradiation (WBI)
  • Active Comparator: Whole breast irradiation (WBI)
    Conventional whole breast irradiation (WBI)
    Intervention: Radiation: Whole breast irradiation (WBI)
  • Experimental: Partial breast irradiation (APBI)
    Accelerated partial breast irradiation (APBI)
    Intervention: Radiation: Accelerated partial breast irradiation (APBI)
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 IMRT: new technical approach and interim analysis of acute toxicity in a phase III randomized clinical trial. Int J Radiat Oncol Biol Phys. 2010 Jun 1;77(2):509-15. doi: 10.1016/j.ijrobp.2009.04.070. Epub 2009 Aug 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
520
Not Provided
February 2014   (final data collection date for primary outcome measure)

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
Female
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT02104895
APBI-IMRT-Florence
Yes
Lorenzo Livi, Azienda Ospedaliero-Universitaria Careggi
Azienda Ospedaliero-Universitaria Careggi
Not Provided
Principal Investigator: Lorenzo Livi, Full Prof Florence University
Principal Investigator: Icro Meattini, M.D. Azienda Ospedaliero-Universitaria Careggi
Azienda Ospedaliero-Universitaria Careggi
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP