Overview

This trial is active, not recruiting.

Conditions breast cancer, radiation toxicity, side effects
Treatment accelerated partial breast irradiation
Phase phase 2
Sponsor National Institute of Oncology, Hungary
Start date December 2006
End date March 2019
Trial size 90 participants
Trial identifier NCT02003560, NIO-APERT_01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Accelerated partial breast irradiation delivered by 3 dimensional conformal radiotherapy or intensity modulated radiotherapy
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.

Primary Outcomes

Measure
late radiation side-effect
time frame: 5 years

Secondary Outcomes

Measure
cosmetic results
time frame: 5 years
local tumor control
time frame: 5 years
regional tumor control
time frame: 5 years
overall survival
time frame: 5 years
disease free survival
time frame: 5 years
cancer specific survival
time frame: 5 years

Eligibility Criteria

Female participants at least 40 years old.

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)

Additional Information

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
Principal investigator Norbert Mészáros, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by National Institute of Oncology, Hungary.