Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2026-02-24 @ 2:30 PM
Study NCT ID:
NCT01343459
Status:
COMPLETED
Last Update Posted:
2023-01-04
First Post:
2011-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intra-Operative Electron Boost and Hypofractionated Whole-Breast Irradiation During Breast-conserving Treatment (BCT)
Sponsor:
Paracelsus Medical University
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HIOB
Brief Summary:
Title:
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 .
Secondary endpoint:
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
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 .
Secondary endpoint:
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
Detailed Description:
Study population:
See Points 4.1 und 4.2 Inclusion/Exclusion criteria of the entire protocol
Operation:
* 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 tumor bed.
Histology: R0-Resection is mandatory
Chemotherapy:
neoadjuvant:allowed adjuvant: allowed.
There are no limitations towards special chemotherapeutic schemes and schedules.
Radiotherapy:
IOERT
* 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).
WBRT
* 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 9 months is allowed.
* 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, optional
* abdominal sonography, optional
* lab tests incl. tumor markers, optional
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 photo documentation in standardized positions
See Points 4.1 und 4.2 Inclusion/Exclusion criteria of the entire protocol
Operation:
* 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 tumor bed.
Histology: R0-Resection is mandatory
Chemotherapy:
neoadjuvant:allowed adjuvant: allowed.
There are no limitations towards special chemotherapeutic schemes and schedules.
Radiotherapy:
IOERT
* 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).
WBRT
* 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 9 months is allowed.
* 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, optional
* abdominal sonography, optional
* lab tests incl. tumor markers, optional
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 photo documentation in standardized positions
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ISIORT 01 | OTHER | ISIORT | View |