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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
  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 ]

Secondary Outcome Measures:
  • Safety [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Acute and late skin toxicity. Heart and lung toxicity.


Other Outcome Measures:
  • Cosmesis [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Patients and physicians-rated cosmesis


Enrollment: 520
Study Start Date: March 2005
Primary Completion Date: February 2014 (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
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
Last Updated: April 4, 2014
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
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 20, 2014