Know Cancer

forgot password

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

Phase 3
35 Years
Open (Enrolling)
Local Neoplasm Recurrence, Toxicity

Thank you

Trial Information

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

Study population:

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

Inclusion Criteria:

- Histological proven invasive breast carcinoma

- Age: ≥ 35 years

- Tumor stage T1-2

- nodal status: N0-1

- Freedom of surgical margins: R0; ≥ 2 mm (both invasive and in situ component).
Exception: In dorsal direction it could be below 2 mm margin if the pectoralis fascia
was additional removed; also in ventral direction it could be < 2mm if skin was a
part of resection and second resection is not possible.

- Also multifocal disease within the same quadrant with a maximum distance of < 5 cm

- all grades G1-G3

- Hormonal receptor and Her-2 status: no limitations

- Informed and undersigned consent

Exclusion Criteria:

- In-situ Carcinoma without invasive component

- Age < 35

- Tumor stage T3,4

- Nodal status >N1

- if irradiation of regional lymphatics is required

- surgical margins/ histological clearance < 2mm

- Re-excision after IOERT

- Immediately secondary mastectomy (not due to recurrence).

- Multicentricity according to international definition: > 5 cm distance to each other

- previous radiotherapy to the involved breast

- Karnofsky Index < 70%

- Mixed connective tissue diseases including rheumatoid Polyarthritis, Thrombangitis

- Chronic pre-existent lung disease (Lungfibrosis, Pneumokoniosis, late-type Allergies
like Farmer lung; Asthma bronchiale, severe Emphysema, COPD III *)

- Cardiac Co-Morbidity: clinically positive coronary vessel disease, St.p. myocardial
infarction, pacemakers and/or defibrillators)

- neoadjuvant CT

- Distant metastases

- breast size (PTV) -≥ 1800 ml

- missing written consent

- observed pregnancy

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

5 year local recurrence rate: Sequential Probability Ratio Test

Outcome Time Frame:

10 years

Safety Issue:


Principal Investigator

Felix Sedlmayer, Prof. MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Paracelsus private university; University Clinic of Radio-Oncology, Müllnerhaupstraße 48 5020 Salzburg/Austria/Europe


Austria: Ethikkommission

Study ID:




Start Date:

January 2011

Completion Date:

May 2021

Related Keywords:

  • Local Neoplasm Recurrence
  • Toxicity
  • Hypofractionated Whole breast irradiation
  • Hypofractionated Whole breast irradiation long term results
  • Breast conserving therapy
  • IORT with electrons in breast cancer
  • IOERT as anticipated Boost
  • IOERT and hypofractionated whole breast irradiation
  • Breast Neoplasms
  • Neoplasms
  • Neoplasm Recurrence, Local
  • Recurrence