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

12. august 2014 opdateret af: Csaba Polgár, National Institute of Oncology, Hungary

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

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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

90

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Ungarn
      • Budapest, Ungarn, H-1122
        • National Institute of Oncology

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Accelerated partial breast irradiation
Accelerated partial breast irradiation delivered by 3 dimensional conformal radiotherapy or intensity modulated radiotherapy
Stråling: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
late radiation side-effect
Tidsramme: 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
5 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
cosmetic results
Tidsramme: 5 years
cosmetic results at 5 years measured by the Harvard criteria
5 years
local tumor control
Tidsramme: 5 years
Local tumor control defined as reappearance of the tumor in the ipsilateral breast
5 years
regional tumor control
Tidsramme: 5 years
regional tumor control at 5 years
5 years
overall survival
Tidsramme: 5 years
overall survival at 5 years
5 years
disease free survival
Tidsramme: 5 years
disease free survival at 5 years
5 years
cancer specific survival
Tidsramme: 5 years
cancer specific survival at 5 years
5 years

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
quality of life
Tidsramme: 5 years
quality of life measured by the EORTC (European Organization for Research and Treatment of Cancer) QLQ-30 and BR-23 questionnaires
5 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Institute of Oncology, Hungary

Efterforskere

  • Studiestol: Csaba Polgár, MD, PhD, MSc, National Institute of Oncology
  • Ledende efterforsker: Norbert Mészáros, MD, National Institute of Oncology

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2006

Primær færdiggørelse (Forventet)

1. marts 2019

Studieafslutning (Forventet)

1. marts 2024

Datoer for studieregistrering

Først indsendt

2. december 2013

Først indsendt, der opfyldte QC-kriterier

2. december 2013

Først opslået (Skøn)

6. december 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. august 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. august 2014

Sidst verificeret

1. august 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NIO-APERT_01

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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