Hypofractionated Whole-Breast Irradiation Preceded by Intra-Operative Radiotherapy With Electrons as Anticipated Boost HIOB A New Option in Breast-Conserving Treatment for Operated Breast Cancer Stages I and II
See Points 4.1 und 4.2 Inclusion/Exclusion criteria of the entire protocol
- Lumpectomy / segmentectomy / tumorectomy with sufficient safety margins (see above).
Lymph node assessment must follow a sentinel node concept.
- Perioperative antibiotic prophylaxis is mandatory
- After IORT, radio-opaque clips have to be fixed at the tumorbed.
neoadjuvant: not allowed adjuvant: allowed.
There are no limitations towards special chemotherapeutic schemes and schedules.
- IOERT is performed on mobile or fixed linacs
- Reference dose: 11 Gy specified as maximum dose, with a minimum target volume dose of
90% encompassing the PTV (i.e. 10 Gy).
- must start within day 36- 56 postoperatively (week 6 - 8 p.o.) in case of adjuvant
hormonal treatment (or no further tumor specific medication)
- In case of adjuvant chemotherapy, a time - gap between IOERT and WBRT up to 6 months is
- Single reference dose per fraction: 2,7 Gy (ICRU)
- Number of fractions: 15, Number of fractions per week: 5
- Total WBRT dose: 40,5 Gy
RT of regional lymphatics: exclusion criterion
Diagnostics of Local recurrence:
- yearly mammographies,
- optional breast sonography, MRI
- LR has to be histologically confirmed
Follow-up screening for detection of metastases (minimum requirements):
- Chest X-Ray,
- abdominal sonography,
- lab tests incl. tumor markers.
Assessment of acute toxicity of WBRT according to CTC-toxicity Scoring-systems:
Assessment of late toxicity according to LENT-SOMA scoring-systems
Assessment of cosmetic outcome according to 5-point- Scoring System (vanLimbergen) starting
before WBRT, including photodocumentation in standardized positions
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
5 year local recurrence rate: Sequential Probability Ratio Test
Felix Sedlmayer, Prof. MD
Paracelsus private university; University Clinic of Radio-Oncology, Müllnerhaupstraße 48 5020 Salzburg/Austria/Europe
ISIORT - 01