Clinical Trial: Intra-Operative Electron Boost and Hypofractionated Whole-Breast Irradiation During Breast-conserving Treatment (BCT)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
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 Stage
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 r
Detailed Summary:
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 fra
Sponsor: Paracelsus Medical University
Current Primary Outcome: 5 year local recurrence rate: Sequential Probability Ratio Test [ Time Frame: 10 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Acute toxicity: CTC-toxicity Scoring-system;Late toxicity: LENT-SOMA scoring-systems [ Time Frame: 10 years ]
Original Secondary Outcome: Same as current
Information By: Paracelsus Medical University
Dates:
Date Received: April 26, 2011
Date Started: January 2011
Date Completion: May 2021
Last Updated: September 18, 2016
Last Verified: September 2016