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 : December 1, 2020
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|
|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 2022|
|Estimated Study Completion Date :||May 2022|
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01343459
|Contact: Felix Sedlmayer, Prof. MDfirstname.lastname@example.org|
|Contact: Gerd Fastner, MDemail@example.com|
|Paracelsus private university; University Clinic of Radio-Oncology||Recruiting|
|Salzburg, Austria, 5020|
|Contact: Felix Sedlmayer, Prof. MD 0043/662/4482/3915 firstname.lastname@example.org|
|Contact: Gerd Fastner, MD 0043/662/4482/58918 email@example.com|
|Principal Investigator: Felix Sedlmayer, Prof. MD|
|Principal Investigator:||Felix Sedlmayer, Prof. MD||Dep. of Radiotherapy and Radio-Oncology, Paracelsus Medical University Salzburg|