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Accelerated Partial Breast Irradiation With 3D-CRT and IMRT (APERT)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Csaba Polgár, National Institute of Oncology, Hungary Identifier:
First received: December 2, 2013
Last updated: August 12, 2014
Last verified: August 2014
The purpose of this study is to determine in a phase II clinical trial whether accelerated partial breast irradiation after breast conserving surgery using 3 dimensional external beam radiotherapy (3D-CRT) and intensity modulated radiotherapy (IMRT) for low-risk invasive breast cancer patients is safe without causing serious late radiation side-effects.

Condition Intervention Phase
Breast Cancer
Radiation Toxicity
Side Effects
Radiation: accelerated partial breast irradiation
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Accelerated Partial Breast Irradiation After Breast Conserving Surgery for Low-risk Invasive Breast Cancer: 3D Conformal Radiotherapy (3D-CRT) and Intensity Modulated Radiotherapy (IMRT) - Prospective Phase II Study

Resource links provided by NLM:

Further study details as provided by National Institute of Oncology, Hungary:

Primary Outcome Measures:
  • late radiation side-effect [ Time Frame: 5 years ]
    Late radiation side-effects at 5 years scored by the RTOG (Radiation Therapy Oncology Group) EORTC (European Organization for Research and Treatment of Cancer) late radiation morbidity scoring scheme

Secondary Outcome Measures:
  • cosmetic results [ Time Frame: 5 years ]
    cosmetic results at 5 years measured by the Harvard criteria

  • local tumor control [ Time Frame: 5 years ]
    Local tumor control defined as reappearance of the tumor in the ipsilateral breast

  • regional tumor control [ Time Frame: 5 years ]
    regional tumor control at 5 years

  • overall survival [ Time Frame: 5 years ]
    overall survival at 5 years

  • disease free survival [ Time Frame: 5 years ]
    disease free survival at 5 years

  • cancer specific survival [ Time Frame: 5 years ]
    cancer specific survival at 5 years

Other Outcome Measures:
  • quality of life [ Time Frame: 5 years ]
    quality of life measured by the EORTC (European Organization for Research and Treatment of Cancer) QLQ-30 and BR-23 questionnaires

Estimated Enrollment: 90
Study Start Date: December 2006
Estimated Study Completion Date: March 2024
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Accelerated partial breast irradiation
Accelerated partial breast irradiation delivered by 3 dimensional conformal radiotherapy or intensity modulated radiotherapy
Radiation: accelerated partial breast irradiation
9 x 4.1 Gy accelerated partial breast irradiation delivered by 3D-CRT or IMRT over 5 consecutive days, using twice-a-day fractionation.

Detailed Description:

It is a sequential phase II trial. Eligible patients after breast conserving surgery (BCS) are treated with accelerated partial breast irradiation (APBI) using three-dimensional conformal radiotherapy (3D-CRT) for the first 45 patients or intensity modulated radiotherapy (IMRT) for the second 45 patients.

Primary end-point of the study: late radiation side-effects at 5 years. Early stopping criteria: Not used as primary end-point is late side-effects. Interim analysis: Not planned Secondary end-points: cosmetic results, quality of life, local recurrence-free survival, regional recurrence free survival, distant metastasis free survival, relapse free survival, overall survival, cancer specific survival.

Null-hypothesis for primary end-point: The incidence of severe (>G2) late radiation side-effects after APBI using 3D-CRT or IMRT will not exceed 10%.


  • by treatment delivery: 3D-CRT - first 45 patients; IMRT - second 45 patients
  • by bra capsize: Capsize A-B; C; and D-D+

Treatment intervention: 9 x 4.1 Gy APBI using 3D-CRT (first 45 patients) or IMRT (second 45 patients) delivered within 5 days, using twice-a-day fractionation.

Clinical target volume (CTV) and Planning target volume (PTV) definition:

CTV = excision cavity + 20 mm minus the actual pathological surgical margin in mm PTV = CTV + 5 mm in each direction


  • ECOG PS, physical examination (inspection and palpation), registration of side-effects (RTOG (Radiation Therapy Oncology Group) EORTC (European Organization for Research and Treatment of Cancer)) early and late radiation morbidity scoring scheme) and cosmetic results (using the Harvard scale) : 7-14 days after RT, than in every 3 months for 2 years, and every 6 months for 5 years.
  • Mammography: at 6, 12, 18, 24 months, and annually thereafter
  • Quality of life questionnaire (QLQ) (e.g. EORTC (European Organization for Research and Treatment of Cancer) QLQ-30 and Breast (BR)-23) before RT, at 7-14 days after RT, at 3, 6, and 12 months, and annually thereafter
  • digital photography: before treatment, at 7-14 days after treatment, and yearly thereafter

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

Inclusion Criteria:

  • previous breast conserving surgery within 12 weeks (in case of adjuvant chemotherapy within 28 days after completion of chemotherapy)
  • patient age > 40 years
  • ECOG performance status: 0-1
  • life expectancy >5 years
  • invasive ductal, papillary, mucinous, medullary or tubular carcinoma
  • unifocal tumor
  • pathological tumor size < or = 30 mm
  • pathological negative axillary nodal status with axillary dissection or sentinel lymph node biopsy
  • surgical clips in the tumor bed
  • pathological surgical free margins of at least 2 mm
  • written informed consent of patients

Exclusion Criteria:

  • Stage III-IV
  • multifocal tumor
  • extensive intraductal component (EIC)
  • ductal or lobular carcinoma in situ (DCIS or LCIS)
  • invasive lobular cancer (ILC)
  • lymph-vascular invasion (LVI)
  • contralateral breast cancer
  • history of treatment for previous breast cancer
  • lactation or breast feeding women
  • Paget-disease of the nipple
  • psychiatric disorder
  • increased radiosensitivity (e.g. collagen vascular disease)
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Please refer to this study by its identifier: NCT02003560

National Institute of Oncology
Budapest, Hungary, H-1122
Sponsors and Collaborators
National Institute of Oncology, Hungary
Study Chair: Csaba Polgár, MD, PhD, MSc National Institute of Oncology
Principal Investigator: Norbert Mészáros, MD National Institute of Oncology
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Csaba Polgár, Professor, National Institute of Oncology, Hungary Identifier: NCT02003560     History of Changes
Other Study ID Numbers: NIO-APERT_01
Study First Received: December 2, 2013
Last Updated: August 12, 2014

Keywords provided by National Institute of Oncology, Hungary:
breast cancer
breast conserving therapy
accelerated partial breast irradiation
3D conformal radiotherapy
intensity modulated radiotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on April 28, 2017