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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- National Institute of Oncology, Hungary
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- late radiation side-effect
- Last Updated
- 11 years ago
Overview
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.
Detailed 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
Investigators
Csaba Polgár
Professor
National Institute of Oncology, Hungary
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
late radiation side-effect
Time Frame: 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
Secondary Outcomes
- local tumor control(5 years)
- overall survival(5 years)
- regional tumor control(5 years)
- cosmetic results(5 years)
- cancer specific survival(5 years)
- disease free survival(5 years)