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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lorenzo Livi, Azienda Ospedaliero-Universitaria Careggi
ClinicalTrials.gov Identifier:
NCT02104895
First received: April 2, 2014
Last updated: July 11, 2016
Last verified: July 2016

April 2, 2014
July 11, 2016
March 2005
June 2013   (final data collection date for primary outcome measure)
Ipsilateral Breast Tumor Recurrence [ Time Frame: 5-year ] [ Designated as safety issue: No ]
We defined local relapse (true recurrence) as the reappearance of the breast cancer in the index quadrant and ipsilateral breast tumours as any new breast cancer diagnosed in other quadrants of the same breast. The sum of local relapses and new ipsilateral breast tumours was defined as the ipsilateral breast tumour recurrence (IBTR). Locoregional tumour recurrence also included any recurrence in the ipsilateral axillary, supraclavicular, or internal mammary chain nodal regions.here we report the percentage of participants in each arm who experienced "Ipsilateral Breast Tumor Recurrence"
Ipsilateral Breast Tumor Recurrence [ Time Frame: 5-year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT02104895 on ClinicalTrials.gov Archive Site
  • Acute Skin Toxicity [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Acute skin toxicity ≥ grade 2, here we report the percentage of participants in each arm who experienced "Acute skin toxicity ≥ grade 2
  • Excellent Cosmesis [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Physician-rated cosmesis, Cosmetic outcome was scored on the four-category Harvard Breast Cosmesis Scale. An excellent cosmetic result score was assigned when the treated breast looked like the contralateral one; a good cosmetic score was assigned for minimal but identifiable radiation effects of the treated breast; a fair score was used if significant radiation effects were readily observable; a poor score was used for severe sequelae due to radiation effects
Safety [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Acute and late skin toxicity. Heart and lung toxicity.
Not Provided
Cosmesis [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Patients and physicians-rated cosmesis
 
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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
520
February 2014
June 2013   (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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Italy
 
NCT02104895
APBI-IMRT-Florence
Yes
Undecided
Not Provided
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
July 2016

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