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

National Institute of Oncology, Hungary

Status and phase

Unknown

Phase 2

Conditions

Breast Cancer

Radiation Toxicity

Side Effects

Treatments

Radiation: accelerated partial breast irradiation

Study type

Interventional

Funder types

Other

Identifiers

NCT02003560

NIO-APERT_01

Details and patient eligibility

About

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.

Full 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

Enrollment

90 estimated patients

Sex

Female

Ages

40+ years old

Volunteers

No Healthy Volunteers

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