- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02003560
Accelerated Partial Breast Irradiation With 3D-CRT and IMRT (APERT)
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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert 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
Studietype
Registrering (Forventet)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
-
Budapest, Ungarn, H-1122
- National Institute of Oncology
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Accelerated partial breast irradiation
Accelerated partial breast irradiation delivered by 3 dimensional conformal radiotherapy or intensity modulated radiotherapy
|
9 x 4.1 Gy accelerated partial breast irradiation delivered by 3D-CRT or IMRT over 5 consecutive days, using twice-a-day fractionation.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Csaba Polgár, MD, PhD, MSc, National Institute of Oncology
- Hovedetterforsker: Norbert Mészáros, MD, National Institute of Oncology
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NIO-APERT_01
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