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: May 29, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention Phase
Breast Cancer
Radiation: Accelerated partial breast irradiation (APBI)
Radiation: Whole breast irradiation (WBI)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomised Phase 3 Trial Of Accelerated Partial Breast Irradiation Using Intensity Modulated Radiotherapy Versus Whole Breast Irradiation

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliero-Universitaria Careggi:

Primary Outcome Measures:
  • 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 BC 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"


Secondary Outcome Measures:
  • 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


Enrollment: 520
Study Start Date: March 2005
Study Completion Date: February 2014
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Whole breast irradiation (WBI)
Conventional whole breast irradiation (WBI)
Radiation: Whole breast irradiation (WBI)
Conventional whole breast irradiation (WBI)
Experimental: Partial breast irradiation (APBI)
Accelerated partial breast irradiation (APBI)
Radiation: Accelerated partial breast irradiation (APBI)
Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)

Detailed 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%).

  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02104895

Locations
Italy
Radiation Oncology Unit, Azienda Ospedaliero-Universitaria Careggi
Florence, Italy, 50134
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria Careggi
Investigators
Principal Investigator: Lorenzo Livi, Full Prof Florence University
Principal Investigator: Icro Meattini, M.D. Azienda Ospedaliero-Universitaria Careggi
  More Information

Publications:

Responsible Party: Lorenzo Livi, Full Professor; Chief Radiotherapy-Oncology Unit; Florence University, Azienda Ospedaliero-Universitaria Careggi
ClinicalTrials.gov Identifier: NCT02104895     History of Changes
Other Study ID Numbers: APBI-IMRT-Florence 
Study First Received: April 2, 2014
Results First Received: November 25, 2015
Last Updated: May 29, 2016
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Azienda Ospedaliero-Universitaria Careggi:
Breast cancer
Early breast cancer
Adjuvant breast cancer
Accelerated partial breast irradiation
Intensity modulated radiotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 28, 2016