NCT02003560

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Dec 2006

Longer than P75 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2013

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

August 13, 2014

Status Verified

August 1, 2014

Enrollment Period

12.3 years

First QC Date

December 2, 2013

Last Update Submit

August 12, 2014

Conditions

Breast CancerRadiation ToxicitySide Effects

Keywords

breast cancerbreast conserving therapyaccelerated partial breast irradiation3D conformal radiotherapyintensity modulated radiotherapy

Outcome Measures

Primary Outcomes (1)

  • late radiation side-effect

    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

    5 years

Secondary Outcomes (6)

  • cosmetic results

    5 years

  • local tumor control

    5 years

  • regional tumor control

    5 years

  • overall survival

    5 years

  • disease free survival

    5 years

  • +1 more secondary outcomes

Other Outcomes (1)

  • quality of life

    5 years

Study Arms (1)

Accelerated partial breast irradiation

EXPERIMENTAL

Accelerated partial breast irradiation delivered by 3 dimensional conformal radiotherapy or intensity modulated radiotherapy

Radiation: accelerated partial breast irradiation

Interventions

accelerated partial breast irradiationRADIATION

9 x 4.1 Gy accelerated partial breast irradiation delivered by 3D-CRT or IMRT over 5 consecutive days, using twice-a-day fractionation.

Accelerated partial breast irradiation

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Oncology

Budapest, H-1122, Hungary

Location

Related Publications (1)

  • Mozsa E, Meszaros N, Major T, Frohlich G, Stelczer G, Sulyok Z, Fodor J, Polgar C. Accelerated partial breast irradiation with external beam three-dimensional conformal radiotherapy. Five-year results of a prospective phase II clinical study. Strahlenther Onkol. 2014 May;190(5):444-50. doi: 10.1007/s00066-014-0633-1. Epub 2014 Mar 12.

    PMID: 24619017DERIVED

MeSH Terms

Conditions

Breast NeoplasmsRadiation Injuries

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesWounds and Injuries

Study Officials

  • Csaba Polgár, MD, PhD, MSc

    National Institute of Oncology

    STUDY CHAIR

  • Norbert Mészáros, MD

    National Institute of Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 2, 2013

First Posted

December 6, 2013

Study Start

December 1, 2006

Primary Completion

March 1, 2019

Study Completion

March 1, 2024

Last Updated

August 13, 2014

Record last verified: 2014-08

Locations

HU(1)