Local Neoplasm RecurrenceHIOBNCT01343459
Intra-Operative Electron Boost and Hypofractionated Whole-Breast Irradiation During Breast-conserving Treatment (BCT)
A study testing HIOB in people with Local Neoplasm Recurrence and Toxicity, run by Paracelsus Medical University at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Local Neoplasm Recurrence, Toxicity
- What is being tested?
- HIOB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,464 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2011to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological proven invasive breast carcinoma
- Age: ≥ 35 years
- Tumor stage T1-2
- nodal status: N0-1
- Freedom of surgical margins: R0 (both invasive and in situ component), that means no ink on tumors (invasive or in situ) (ago-online.de) .
- Also multifocal disease within the same quadrant with a maximum distance of < 5 cm
Show all 9Show fewer
- all grades G1-G3
- Hormonal receptor and Her-2 status: no limitations
- Informed and undersigned consent
Who cannot join
- In-situ Carcinoma without invasive component
- Age < 35
- Tumor stage T3,4
- Nodal status >N1
- if irradiation of regional lymphatics is required
- R1
Show all 18Show fewer
- 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 obliterans
- Chronic pre-existent lung disease (Lung fibrosis, 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)
- Distant metastases
- breast size (PTV) > 2500 ml
- missing written consent
- observed pregnancy
Trial locations and contacts
1 site in 1 country.
Austria1 site
Paracelsus private university; University Clinic of Radio-Oncology
Salzburg, 5020
About this study
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
Title:
HIOB - Hypofractionated Whole-Breast Irradiation preceded by Intraoperative Radiotherapy with Electrons as anticipated Boost ISIORT- 01
Read more
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
Read the 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
- Conditions
- Local Neoplasm Recurrence, Toxicity
- Being tested
- HIOB
- Keywords
- 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
- Medical subject headings
- Neoplasm Recurrence, Local
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIOBRadiation
IOERT single shot as a boost followed by hypofractionated WBRT (HIOB)
- 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
| Study group | Role | What they receive |
|---|---|---|
| IOERT followed by hypofractionated WBRT | Experimental | HIOB: IOERT of 11.1 Gy followed by WBRT with 15 times 2.7 Gy per fraction. Receives: Radiation: HIOB |
What is being measured
The primary outcome is the main question the study is designed to answer.
5 year local recurrence rate: Sequential Probability Ratio Test
Sequential Probability Ratio Test
Measured: 10 years
Secondary outcomes (1)
Acute toxicity: CTC-toxicity Scoring-system;Late toxicity: LENT-SOMA scoring-systems
CTC-toxicity Scoring-System;LENT-SOMA scoring-systems
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startJan 2011
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Local Neoplasm RecurrenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,464 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paracelsus Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- LKH Klagenfurt, Poznan University of Medical Sciences, San Filippo Neri General Hospital, Avera McKennan Hospital & University Health Center, St. Luke's Hospital ,Cedar Rapids, US, A.O.U. San Giovanni Battista di Torino, Italy, IRCCS Cancer Referral Center of Basilicata, Heinrich-Heine University, Duesseldorf, St. Elisabeth-Hospital Köln-Hohenlind, Germany, S.C. Radiotherapia Aziendale Umbria, Italy, Azienda Ospedaliero, Universitaria Ospedali Riuniti, Fondazione Salvatore Maugeri, Marien Hospital Düsseldorf, Azienda Ospedaliero Universitaria Maggiore della Carita, Philipps University Marburg, Istituti Tumori Giovanni Paolo II, University Hospital of Ferrara
- Responsible party
- Principal investigator, Gerd Fastner, Paracelsus Medical University
- Investigators
- Gerd Fastner, Assoc.Prof., Principal investigator, Dep. of Radiotherapy and Radio-Oncology, Paracelsus Medical University Salzburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343459
- Sponsor's protocol ID
- ISIORT - 01
- Other IDs
- ISIORT 01
- Acronym
- HIOB
- Status last verified
- Dec 2022
- First submitted
- 26 Apr 2011
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Bartelink H, Horiot JC, Poortmans P, Struikmans H, Van den Bogaert W, Barillot I, Fourquet A, Borger J, Jager J, Hoogenraad W, Collette L, Pierart M; European Organization for Research and Treatment of Cancer Radiotherapy and Breast Cancer Groups. Recurrence rates after treatment of breast cancer with standard radiotherapy with or without additional radiation. N Engl J Med. 2001 Nov 8;345(19):1378-87. doi: 10.1056/NEJMoa010874.
PubMed 11794170START Trialists' Group; Bentzen SM, Agrawal RK, Aird EG, Barrett JM, Barrett-Lee PJ, Bentzen SM, Bliss JM, Brown J, Dewar JA, Dobbs HJ, Haviland JS, Hoskin PJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Morgan DA, Owen JR, Simmons S, Sumo G, Sydenham MA, Venables K, Yarnold JR. The UK Standardisation of Breast Radiotherapy (START) Trial B of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial. Lancet. 2008 Mar 29;371(9618):1098-107. doi: 10.1016/S0140-6736(08)60348-7. Epub 2008 Mar 19.
PubMed 18355913Whelan TJ, Kim DH, Sussman J. Clinical experience using hypofractionated radiation schedules in breast cancer. Semin Radiat Oncol. 2008 Oct;18(4):257-64. doi: 10.1016/j.semradonc.2008.04.008.
PubMed 18725113Whelan TJ, Pignol JP, Levine MN, Julian JA, MacKenzie R, Parpia S, Shelley W, Grimard L, Bowen J, Lukka H, Perera F, Fyles A, Schneider K, Gulavita S, Freeman C. Long-term results of hypofractionated radiation therapy for breast cancer. N Engl J Med. 2010 Feb 11;362(6):513-20. doi: 10.1056/NEJMoa0906260.
PubMed 20147717Ivaldi GB, Leonardi MC, Orecchia R, Zerini D, Morra A, Galimberti V, Gatti G, Luini A, Veronesi P, Ciocca M, Sangalli C, Fodor C, Veronesi U. Preliminary results of electron intraoperative therapy boost and hypofractionated external beam radiotherapy after breast-conserving surgery in premenopausal women. Int J Radiat Oncol Biol Phys. 2008 Oct 1;72(2):485-93. doi: 10.1016/j.ijrobp.2007.12.038. Epub 2008 Apr 11.
PubMed 18407434START Trialists' Group; Bentzen SM, Agrawal RK, Aird EG, Barrett JM, Barrett-Lee PJ, Bliss JM, Brown J, Dewar JA, Dobbs HJ, Haviland JS, Hoskin PJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Morgan DA, Owen JR, Simmons S, Sumo G, Sydenham MA, Venables K, Yarnold JR. The UK Standardisation of Breast Radiotherapy (START) Trial A of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial. Lancet Oncol. 2008 Apr;9(4):331-41. doi: 10.1016/S1470-2045(08)70077-9. Epub 2008 Mar 19.
PubMed 18356109Owen JR, Ashton A, Bliss JM, Homewood J, Harper C, Hanson J, Haviland J, Bentzen SM, Yarnold JR. Effect of radiotherapy fraction size on tumour control in patients with early-stage breast cancer after local tumour excision: long-term results of a randomised trial. Lancet Oncol. 2006 Jun;7(6):467-71. doi: 10.1016/S1470-2045(06)70699-4.
PubMed 16750496Yarnold J, Ashton A, Bliss J, Homewood J, Harper C, Hanson J, Haviland J, Bentzen S, Owen R. Fractionation sensitivity and dose response of late adverse effects in the breast after radiotherapy for early breast cancer: long-term results of a randomised trial. Radiother Oncol. 2005 Apr;75(1):9-17. doi: 10.1016/j.radonc.2005.01.005. Epub 2005 Mar 16.
PubMed 15878095Reitsamer R, Sedlmayer F, Kopp M, Kametriser G, Menzel C, Deutschmann H, Nairz O, Hitzl W, Peintinger F. The Salzburg concept of intraoperative radiotherapy for breast cancer: results and considerations. Int J Cancer. 2006 Jun 1;118(11):2882-7. doi: 10.1002/ijc.21727.
PubMed 16381011Reitsamer R, Peintinger F, Sedlmayer F, Kopp M, Menzel C, Cimpoca W, Glueck S, Rahim H, Kopp P, Deutschmann H, Merz F, Brandis M, Kogelnik H. Intraoperative radiotherapy given as a boost after breast-conserving surgery in breast cancer patients. Eur J Cancer. 2002 Aug;38(12):1607-10. doi: 10.1016/s0959-8049(02)00116-8.
PubMed 12142049Sedlmayer F, Fastner G, Merz F, Deutschmann H, Reitsamer R, Menzel C, Ciabattoni A, Petrucci A, Hager E, Willich N, Orecchia R, Valentini V; International Society of Intraoperative Radiotherapy. IORT with electrons as boost strategy during breast conserving therapy in limited stage breast cancer: results of an ISIORT pooled analysis. Strahlenther Onkol. 2007 Dec;183 Spec No 2:32-4. doi: 10.1007/s00066-007-2013-6. No abstract available.
PubMed 18167006Whelan T, MacKenzie R, Julian J, Levine M, Shelley W, Grimard L, Lada B, Lukka H, Perera F, Fyles A, Laukkanen E, Gulavita S, Benk V, Szechtman B. Randomized trial of breast irradiation schedules after lumpectomy for women with lymph node-negative breast cancer. J Natl Cancer Inst. 2002 Aug 7;94(15):1143-50. doi: 10.1093/jnci/94.15.1143.
PubMed 12165639
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01343459
- Acronym / sponsor ID
- HIOB / ISIORT - 01
- Conditions
- Local Neoplasm Recurrence, Toxicity
- Keywords
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,464 participants (actual)
- Lead sponsor
- Paracelsus Medical UniversityUniversity, hospital or other
- Collaborators
- LKH Klagenfurt, Poznan University of Medical Sciences, San Filippo Neri General Hospital, Avera McKennan Hospital & University Health Center, St. Luke's Hospital ,Cedar Rapids, US, A.O.U. San Giovanni Battista di Torino, Italy, IRCCS Cancer Referral Center of Basilicata, Heinrich-Heine University, Duesseldorf, St. Elisabeth-Hospital Köln-Hohenlind, Germany, S.C. Radiotherapia Aziendale Umbria, Italy, Azienda Ospedaliero, Universitaria Ospedali Riuniti, Fondazione Salvatore Maugeri, Marien Hospital Düsseldorf, Azienda Ospedaliero Universitaria Maggiore della Carita, Philipps University Marburg, Istituti Tumori Giovanni Paolo II, University Hospital of Ferrara
- Study start
- Jan 2011 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 28 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IOERT followed by hypofractionated WBRT | Experimental | Radiation: HIOBHIOB: IOERT of 11.1 Gy followed by WBRT with 15 times 2.7 Gy per fraction. |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histological proven invasive breast carcinoma
- Age: ≥ 35 years
- Tumor stage T1-2
- nodal status: N0-1
- Freedom of surgical margins: R0 (both invasive and in situ component), that means no ink on tumors (invasive or in situ) (ago-online.de) .
Key exclusion criteria (18 listed)
- In-situ Carcinoma without invasive component
- Age < 35
- Tumor stage T3,4
- Nodal status >N1
- if irradiation of regional lymphatics is required
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIOBIOERT single shot as a boost followed by hypofractionated WBRT (HIOB) * 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 | Radiation | IOERT followed by hypofractionated WBRT |
Primary outcome
5 year local recurrence rate: Sequential Probability Ratio Test
Time frame: 10 years
Sequential Probability Ratio Test
1 secondary outcome
Acute toxicity: CTC-toxicity Scoring-system;Late toxicity: LENT-SOMA scoring-systems
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Background: PubMed 11794170Bartelink H, Horiot JC, Poortmans P, Struikmans H, Van den Bogaert W, Barillot I, Fourquet A, Borger J, Jager J, Hoogenraad W, Collette L, Pierart M; European Organization for Research and Treatment of Cancer Radiotherapy and Breast Cancer Groups. Recurrence rates after treatment of breast cancer with standard radiotherapy with or without additional radiation. N Engl J Med. 2001 Nov 8;345(19):1378-87. doi: 10.1056/NEJMoa010874.
- Background: PubMed 18355913START Trialists' Group; Bentzen SM, Agrawal RK, Aird EG, Barrett JM, Barrett-Lee PJ, Bentzen SM, Bliss JM, Brown J, Dewar JA, Dobbs HJ, Haviland JS, Hoskin PJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Morgan DA, Owen JR, Simmons S, Sumo G, Sydenham MA, Venables K, Yarnold JR. The UK Standardisation of Breast Radiotherapy (START) Trial B of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial. Lancet. 2008 Mar 29;371(9618):1098-107. doi: 10.1016/S0140-6736(08)60348-7. Epub 2008 Mar 19.
- Background: PubMed 18725113Whelan TJ, Kim DH, Sussman J. Clinical experience using hypofractionated radiation schedules in breast cancer. Semin Radiat Oncol. 2008 Oct;18(4):257-64. doi: 10.1016/j.semradonc.2008.04.008.
- Background: PubMed 20147717Whelan TJ, Pignol JP, Levine MN, Julian JA, MacKenzie R, Parpia S, Shelley W, Grimard L, Bowen J, Lukka H, Perera F, Fyles A, Schneider K, Gulavita S, Freeman C. Long-term results of hypofractionated radiation therapy for breast cancer. N Engl J Med. 2010 Feb 11;362(6):513-20. doi: 10.1056/NEJMoa0906260.
- Background: PubMed 18407434Ivaldi GB, Leonardi MC, Orecchia R, Zerini D, Morra A, Galimberti V, Gatti G, Luini A, Veronesi P, Ciocca M, Sangalli C, Fodor C, Veronesi U. Preliminary results of electron intraoperative therapy boost and hypofractionated external beam radiotherapy after breast-conserving surgery in premenopausal women. Int J Radiat Oncol Biol Phys. 2008 Oct 1;72(2):485-93. doi: 10.1016/j.ijrobp.2007.12.038. Epub 2008 Apr 11.
- Background: PubMed 18356109START Trialists' Group; Bentzen SM, Agrawal RK, Aird EG, Barrett JM, Barrett-Lee PJ, Bliss JM, Brown J, Dewar JA, Dobbs HJ, Haviland JS, Hoskin PJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Morgan DA, Owen JR, Simmons S, Sumo G, Sydenham MA, Venables K, Yarnold JR. The UK Standardisation of Breast Radiotherapy (START) Trial A of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial. Lancet Oncol. 2008 Apr;9(4):331-41. doi: 10.1016/S1470-2045(08)70077-9. Epub 2008 Mar 19.
- Background: PubMed 16750496Owen JR, Ashton A, Bliss JM, Homewood J, Harper C, Hanson J, Haviland J, Bentzen SM, Yarnold JR. Effect of radiotherapy fraction size on tumour control in patients with early-stage breast cancer after local tumour excision: long-term results of a randomised trial. Lancet Oncol. 2006 Jun;7(6):467-71. doi: 10.1016/S1470-2045(06)70699-4.
- Background: PubMed 15878095Yarnold J, Ashton A, Bliss J, Homewood J, Harper C, Hanson J, Haviland J, Bentzen S, Owen R. Fractionation sensitivity and dose response of late adverse effects in the breast after radiotherapy for early breast cancer: long-term results of a randomised trial. Radiother Oncol. 2005 Apr;75(1):9-17. doi: 10.1016/j.radonc.2005.01.005. Epub 2005 Mar 16.
- Background: PubMed 16381011Reitsamer R, Sedlmayer F, Kopp M, Kametriser G, Menzel C, Deutschmann H, Nairz O, Hitzl W, Peintinger F. The Salzburg concept of intraoperative radiotherapy for breast cancer: results and considerations. Int J Cancer. 2006 Jun 1;118(11):2882-7. doi: 10.1002/ijc.21727.
- Background: PubMed 12142049Reitsamer R, Peintinger F, Sedlmayer F, Kopp M, Menzel C, Cimpoca W, Glueck S, Rahim H, Kopp P, Deutschmann H, Merz F, Brandis M, Kogelnik H. Intraoperative radiotherapy given as a boost after breast-conserving surgery in breast cancer patients. Eur J Cancer. 2002 Aug;38(12):1607-10. doi: 10.1016/s0959-8049(02)00116-8.
- Background: PubMed 18167006Sedlmayer F, Fastner G, Merz F, Deutschmann H, Reitsamer R, Menzel C, Ciabattoni A, Petrucci A, Hager E, Willich N, Orecchia R, Valentini V; International Society of Intraoperative Radiotherapy. IORT with electrons as boost strategy during breast conserving therapy in limited stage breast cancer: results of an ISIORT pooled analysis. Strahlenther Onkol. 2007 Dec;183 Spec No 2:32-4. doi: 10.1007/s00066-007-2013-6. No abstract available.
- Background: PubMed 12165639Whelan T, MacKenzie R, Julian J, Levine M, Shelley W, Grimard L, Lada B, Lukka H, Perera F, Fyles A, Laukkanen E, Gulavita S, Benk V, Szechtman B. Randomized trial of breast irradiation schedules after lumpectomy for women with lymph node-negative breast cancer. J Natl Cancer Inst. 2002 Aug 7;94(15):1143-50. doi: 10.1093/jnci/94.15.1143.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerd Fastner, Assoc.Prof. principal investigator
Dep. of Radiotherapy and Radio-Oncology, Paracelsus Medical University Salzburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIOB in people with Local Neoplasm Recurrence and Toxicity, run by Paracelsus Medical University at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5 year local recurrence rate: Sequential Probability Ratio Test (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01343459, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.