Invasive Lobular and Ductal CarcinomaNCT01295723
Intraoperative Boost Radiotherapy With Electrons (IOERT) Followed By Hypofractionated Whole-Breast Irradiation (WBRT)
A study testing Hypofractionated Whole Breast Radiation Therapy and Intraoperative Electron Radiation Therapy in people with Invasive Lobular and Ductal Carcinoma, run by St. Joseph Hospital of Orange at 1 site in United States.
Trial summary
Hypofractionated intraoperative boost (HIOB) is defined as hypofractionated WBRT (40.5 Gy in 2.7 Gy per fraction) preceded by an intraoperative boost to the tumor bed (10 Gy IOERT). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Invasive Lobular and Ductal Carcinoma
- What is being tested?
- Hypofractionated Whole Breast Radiation Therapy and Intraoperative Electron Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological proven invasive breast carcinoma (ductal and lobular)
- Age > 40 years
- Karnofsky performance status >70%
- Single discrete tumor or focal microcalcifications that can be imaged on a specimen radiograph or multifocal disease within the same quadrant with a maximum dimension of 4 cm (invasive foci)
- Nodal Status: NO-1
- Clear surgical margins: R0; min 2mm. Re-excision after IOERT is permitted but not required to achieve (-) margin.
Show all 9Show fewer
- All grades G1 - G3
- Any hormonal receptor and Her-2 status
- Informed consent
Who cannot join
- In-situ Carcinoma without invasive component or multifocal disease > 4 cm
- Tumor stage: T3 or 4
- Nodal Status > N1 pathologically
- Surgical margins < 2mm
- Multicentricity
- Previous radiotherapy to the involved breast
Show all 10Show fewer
- Karnofsky Index < 70%
- Mixed connective tissue diseases e.g. rheumatoid polyarthritis, thromboangitis obliterans, systemic lupus.
- Distant metastases
- Unable to provide written consent
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Joseph Hospital of Orange
Orange, California, 92868
About this study
Hypofractionated intraoperative boost (HIOB) is defined as hypofractionated WBRT (40.5 Gy in 2.7 Gy per fraction) preceded by an intraoperative boost to the tumor bed (10 Gy IOERT). The HIOB study concept will test whether such a combined schedule is superior or iso-effective standard RT in terms of local control and cosmetic outcome.
Read the detailed description
The purpose of this research study is to find out the effects (good and bad) of adding a dose of radiation to the area of the cancer during surgery to whole breast radiation therapy (WBRT) after surgery. IOERT is the application of electron radiation directly to the residual tumor or tumor bed during cancer surgery. WBRT is a type of radiation therapy used to treat patients who have cancer in the breast covering the entire breast tissue. Both immediate and long-term effects will be measured.
For patients with certain types of breast cancer, one standard treatment is removal of the area of cancer and a small amount of normal tissue around it followed by breast radiation. The radiation treatment in this situation usually lasts 3 to 5 1/2 weeks of WBRT followed by 5-8 daily radiation treatments at the site where the lump was removed called a "boost". During this study, the single dose of electron irradiation (IOERT) given at the surgical site during the operation will replace the usual 5-8 days of localized radiation and the whole breast radiation will last 3 weeks.
- Conditions
- Invasive Lobular and Ductal Carcinoma
- Being tested
- Hypofractionated Whole Breast Radiation Therapy, Intraoperative Electron Radiation Therapy
- Keywords
- Breast cancer, Radiation therapy, Mobetron, IOERT, IORT, Hypofractionated radiation therapy, Partial breast radiation
- Medical subject headings
- Carcinoma, Ductal, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated Whole Breast Radiation TherapyRadiation
Hypofractionated Whole Breast Radiation Therapy must start within 14-56 days postoperatively (week 2-8 post-op)
- Single reference dose per fraction: 2.7 Gy (ICRU)
- Number of fractions: 15
- Number of fractions per week: 5
- Regular Radiation Therapy breaks: Weekend/ Holidays (not exceeding 7 days break)
- Total dose: 50.5 Gy (40.5 WBRT + 10 Gy boost) Radiation: Intraoperative Electron Radiation Therapy
Intraoperative Electron Radiation TherapyRadiation
Also called Mobetron
Intraoperative Electron Radiation Therapy (IOERT) is delivered after completion of the lumpectomy and sentinel node procedure. IOERT is performed on mobile or fixed linac with variable electron energies in the range of 4-12 MeV
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative Electron Radiation Therapy | Experimental | A single dose of electron irradiation given at the surgical site during the operation to remove the cancerous tumor will replace the usual 5-8 days of localized radiation. Hypofractionated Whole Breast Radiation Therapy must start within 14-56 days post operatively. Receives: Radiation: Hypofractionated Whole Breast Radiation Therapy; Radiation: Intraoperative Electron Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of acute and late toxicity
Assessment of acute toxicity of breast irradiation according to CTC-toxicity Scoring - systems:
- At the end of Radiation Therapy
- At time of first follow-up investigation (week 8 - 10)
Assessment of late toxicity according to NSABP scoring - systems at 6, 12, 24, 36, 48, and 60 months
Measured: 5 years
Secondary outcomes (3)
Cosmetic Evaluation
Assessment of cosmetic outcome according to 5-point scoring system
- Before Whole Breast Radiation Therapy
- Not earlier than 7 months after Whole Breast Radiation Therapy
- At yearly follow-up (photodocumentation in standardized positions) for 5 years.
Measured: 5 years
Disease Free Survival
Recurrence assessments as documented at post-op follow-ups per protcol.
Measured: 5 years
Overall Survival
The length of time from the start of treatment to death within the 5 year period.
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2021
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Lobular and Ductal CarcinomaStudies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph Hospital of Orange
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Afshin Forouzannia, M.D., Principal investigator, The Center for Cancer Prevention & Treatment at St. Joseph Hospital of Orange
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295723
- Sponsor's protocol ID
- 11-003 Mobetron
- Status last verified
- May 2022
- First submitted
- 11 Feb 2011
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Boost Radiotherapy With Electrons (IOERT) Followed By Hypofractionated Whole-Breast Irradiation (WBRT)
- ClinicalTrials.gov ID
- NCT01295723
- Acronym / sponsor ID
- 11-003 Mobetron
- Conditions
- Invasive Lobular and Ductal Carcinoma
- Keywords
- Breast cancer, Radiation therapy, Mobetron, IOERT, IORT, Hypofractionated radiation therapy, Partial breast radiation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- St. Joseph Hospital of OrangeUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2022 (estimated)
- First posted
- 14 Feb 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.
Hypofractionated intraoperative boost (HIOB) is defined as hypofractionated WBRT (40.5 Gy in 2.7 Gy per fraction) preceded by an intraoperative boost to the tumor bed (10 Gy IOERT). The HIOB study concept will test whether such a combined schedule is superior or iso-effective standard RT in terms of local control and cosmetic outcome.
Detailed description
The purpose of this research study is to find out the effects (good and bad) of adding a dose of radiation to the area of the cancer during surgery to whole breast radiation therapy (WBRT) after surgery. IOERT is the application of electron radiation directly to the residual tumor or tumor bed during cancer surgery. WBRT is a type of radiation therapy used to treat patients who have cancer in the breast covering the entire breast tissue. Both immediate and long-term effects will be measured.
For patients with certain types of breast cancer, one standard treatment is removal of the area of cancer and a small amount of normal tissue around it followed by breast radiation. The radiation treatment in this situation usually lasts 3 to 5 1/2 weeks of WBRT followed by 5-8 daily radiation treatments at the site where the lump was removed called a "boost". During this study, the single dose of electron irradiation (IOERT) given at the surgical site during the operation will replace the usual 5-8 days of localized radiation and the whole breast radiation will last 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraoperative Electron Radiation Therapy | Experimental | Radiation: Hypofractionated Whole Breast Radiation Therapy, Radiation: Intraoperative Electron Radiation TherapyA single dose of electron irradiation given at the surgical site during the operation to remove the cancerous tumor will replace the usual 5-8 days of localized radiation. Hypofractionated Whole Breast Radiation Therapy must start within 14-56 days post operatively. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histological proven invasive breast carcinoma (ductal and lobular)
- Age > 40 years
- Karnofsky performance status >70%
- Single discrete tumor or focal microcalcifications that can be imaged on a specimen radiograph or multifocal disease within the same quadrant with a maximum dimension of 4 cm (invasive foci)
- Nodal Status: NO-1
Key exclusion criteria (10 listed)
- In-situ Carcinoma without invasive component or multifocal disease > 4 cm
- Tumor stage: T3 or 4
- Nodal Status > N1 pathologically
- Surgical margins < 2mm
- Multicentricity
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 |
|---|---|---|
| Hypofractionated Whole Breast Radiation TherapyHypofractionated Whole Breast Radiation Therapy must start within 14-56 days postoperatively (week 2-8 post-op) * Single reference dose per fraction: 2.7 Gy (ICRU) * Number of fractions: 15 * Number of fractions per week: 5 * Regular Radiation Therapy breaks: Weekend/ Holidays (not exceeding 7 days break) * Total dose: 50.5 Gy (40.5 WBRT + 10 Gy boost) Radiation: Intraoperative Electron Radiation Therapy | Radiation | Intraoperative Electron Radiation Therapy |
| Intraoperative Electron Radiation TherapyAlso: MobetronIntraoperative Electron Radiation Therapy (IOERT) is delivered after completion of the lumpectomy and sentinel node procedure. IOERT is performed on mobile or fixed linac with variable electron energies in the range of 4-12 MeV | Radiation | Intraoperative Electron Radiation Therapy |
Primary outcome
Assessment of acute and late toxicity
Time frame: 5 years
Assessment of acute toxicity of breast irradiation according to CTC-toxicity Scoring - systems: * At the end of Radiation Therapy * At time of first follow-up investigation (week 8 - 10) Assessment of late toxicity according to NSABP scoring - systems at 6, 12, 24, 36, 48, and 60 months
3 secondary outcomes
Cosmetic Evaluation
Time frame: 5 years
Disease Free Survival
Time frame: 5 years
Overall Survival
Time frame: 5 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
Related trials for Invasive Lobular and Ductal Carcinoma
RecruitingObservational study
Negative/Low Hormone Receptor And/or HER2 POsitive Lobular Invasive Breast Carcinoma - A Real-World International Cohort Study
Lobular Breast Carcinoma
Not yet recruitingPhase 4
FES PET/MRI for Occult Disease in Lobular Breast Cancer
Lobular Breast Carcinoma
RecruitingPhase 1/2
[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
Colorectal Cancer, Epithelial Ovarian Cancer
Active, not recruitingPhase 3
Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer
Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma
Recruiting
Decision Making Tool in Supporting Decision Making in Contralateral Prophylactic Mastectomy in Patients With Newly Diagnosed Breast Cancer
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
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.
Afshin Forouzannia, M.D. principal investigator
The Center for Cancer Prevention & Treatment at St. Joseph Hospital of Orange
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated Whole Breast Radiation Therapy and Intraoperative Electron Radiation Therapy in people with Invasive Lobular and Ductal Carcinoma, run by St. Joseph Hospital of Orange at 1 site in United States.
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 10 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: status not confirmed, as of the sponsor's last update on 11 May 2022. 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 United States. 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?
Results are not available in the source record.
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?
Assessment of acute and late toxicity (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2022.