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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Csaba Polgár, National Institute of Oncology, Hungary
ClinicalTrials.gov Identifier:
NCT02003560
First received: December 2, 2013
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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: Endpoint Classification: Safety Study
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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    cosmetic results at 5 years measured by the Harvard criteria

  • local tumor control [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Local tumor control defined as reappearance of the tumor in the ipsilateral breast

  • regional tumor control [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    regional tumor control at 5 years

  • overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    overall survival at 5 years

  • disease free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    disease free survival at 5 years

  • cancer specific survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    cancer specific survival at 5 years


Other Outcome Measures:
  • quality of life [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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%.

Stratification:

  • 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

Follow-up:

  • 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
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  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: NCT02003560

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

No publications provided by National Institute of Oncology, Hungary

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Csaba Polgár, Professor, National Institute of Oncology, Hungary
ClinicalTrials.gov Identifier: NCT02003560     History of Changes
Other Study ID Numbers: NIO-APERT_01
Study First Received: December 2, 2013
Last Updated: August 12, 2014
Health Authority: Hungary: Scientific and Medical Research Council Ethics Committee

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
Radiation Injuries
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on August 28, 2014