Breast Cancer, Radiation Toxicity, Side Effects
Conditions
Keywords
breast cancer, breast conserving therapy, accelerated partial breast irradiation, 3D conformal radiotherapy, intensity modulated radiotherapy
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
Interventions
RADIATIONaccelerated 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.
Sponsors
National Institute of Oncology, Hungary
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| late radiation side-effect | 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
| Measure | Time frame | Description |
|---|---|---|
| local tumor control | 5 years | Local tumor control defined as reappearance of the tumor in the ipsilateral breast |
| regional tumor control | 5 years | regional tumor control at 5 years |
| overall survival | 5 years | overall survival at 5 years |
| cosmetic results | 5 years | cosmetic results at 5 years measured by the Harvard criteria |
| cancer specific survival | 5 years | cancer specific survival at 5 years |
| disease free survival | 5 years | disease free survival at 5 years |
Other
| Measure | Time frame | Description |
|---|---|---|
| quality of life | 5 years | quality of life measured by the EORTC (European Organization for Research and Treatment of Cancer) QLQ-30 and BR-23 questionnaires |
Countries
Hungary
Outcome results
None listed