Intra-Operative Electron Boost and Hypofractionated Whole-Breast Irradiation During Breast-conserving Treatment (BCT) (HIOB)
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|ClinicalTrials.gov Identifier: NCT01343459|
Recruitment Status : Recruiting
First Posted : April 28, 2011
Last Update Posted : January 9, 2018
HIOB - Hypofractionated Whole-Breast Irradiation preceded by Intraoperative Radiotherapy with Electrons as anticipated Boost ISIORT- 01
HIOB is defined as hypofractionated WBRT (40,5 Gy in 2,7 Gy per fraction) preceded by an Intraoperative Boost to the tumor bed ( 90 % reference dose of 10 Gy, 11,1 Gy Dmax IOERT).
Primary endpoint is the proof of superiority of a new treatment regimen.
The HIOB study concept is supposed to test the hypothesis whether such a combined schedule is superior (or iso-effective) towards "standard" RT in terms of local control and cosmetic outcome.
In the vast majority of all publications, annual and 5 year in-breast recurrence rates following BCT showed a clear dependency on patient age within the following boundaries (primary references):
Age > 50: Bartelink (standard): 0,7% (annual) 3,5% (5y) START B (best): 0,4 %(annual) 2,0% (5y)
Age 41-50: Bartelink (standard) 1,2% (annual) 6,0% (5y) Whelan (best) 0,72%(annual) 3,6% (5y)
Age ≥ 35-40 Bartelink (standard) 2% (annual) 10% (5y) Whelan (best) 0,72% (annual) 3,6% (5y)
long these three different age groups, benchmarking will be performed against the best published results following `Golden Standard`RT, usually defined as conventionally fractionated WBRT with 50 Gy (25 x2) plus external tumor bed boost with 10-16 Gy electrons (5-8x2Gy).
Superiority is defined as going below the lower limit of the estimated 5 year local recurrence rate within the respective age group Inferiority is defined as crossing the respective upper limit .
Disease free survival
Tertiary endpoint: toxicity assessment (acute and late) including long term cosmetic evaluation
Study design and statistics:
- Prospective multicenter single-armed
- Sequential probability ratio test (SPRT)
- Separate analysis within three different age groups
Estimated Accrual time: strongly dependent on recruitment per year within the respective age group . Due to the statistical estimation of Szenario A and B the study will close after max. Time-period of 10 years in case of A or 6,4 years in case of B..
Principal investigators and study coordinators:
UC of Radiotherapy and Radio-Oncology UC of Special Gynecology and Breast Cancer Center Landeskrankenhaus Salzburg, Paracelsus University Clinics
|Condition or disease||Intervention/treatment||Phase|
|Local Neoplasm Recurrence Toxicity||Radiation: HIOB||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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 Start Date :||January 2011|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||May 2021|
Experimental: IOERT followed by hypofractionated WBRT
HIOB: IOERT of 11.1 Gy followed by WBRT with 15 times 2.7 Gy per fraction.
IOERT single shot as a boost followed by hypofractionated WBRT (HIOB)
- 5 year local recurrence rate: Sequential Probability Ratio Test [ Time Frame: 10 years ]Sequential Probability Ratio Test
- Acute toxicity: CTC-toxicity Scoring-system;Late toxicity: LENT-SOMA scoring-systems [ Time Frame: 10 years ]CTC-toxicity Scoring-System;LENT-SOMA scoring-systems
- Cosmesis [ Time Frame: 10 years ]van Limbergen Scoring System
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01343459
|Contact: Felix Sedlmayer, Prof. MDemail@example.com|
|Contact: Gerd Fastner, MDfirstname.lastname@example.org|
|Paracelsus private university; University Clinic of Radio-Oncology||Recruiting|
|Salzburg, Austria, 5020|
|Contact: Felix Sedlmayer, Prof. MD 0043/662/4482/3915 email@example.com|
|Contact: Gerd Fastner, MD 0043/662/4482/58918 firstname.lastname@example.org|
|Principal Investigator: Felix Sedlmayer, Prof. MD|
|Principal Investigator:||Felix Sedlmayer, Prof. MD||Paracelsus private university; University Clinic of Radio-Oncology, Müllnerhaupstraße 48 5020 Salzburg/Austria/Europe|