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Intraoperative Boost Radiotherapy With Electrons (IOERT) Followed By Hypofractionated Whole-Breast Irradiation (WBRT)

Primary Purpose

Invasive Lobular and Ductal Carcinoma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hypofractionated Whole Breast Radiation Therapy
Intraoperative Electron Radiation Therapy
Sponsored by
St. Joseph Hospital of Orange
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Invasive Lobular and Ductal Carcinoma focused on measuring Breast cancer, Radiation therapy, Mobetron, IOERT, IORT, Hypofractionated radiation therapy, Partial breast radiation

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.
  • All grades G1 - G3
  • Any hormonal receptor and Her-2 status
  • Informed consent

Exclusion Criteria:

  • 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
  • Karnofsky Index < 70%
  • Mixed connective tissue diseases e.g. rheumatoid polyarthritis, thromboangitis obliterans, systemic lupus.
  • Distant metastases
  • Unable to provide written consent

Sites / Locations

  • St. Joseph Hospital of Orange

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intraoperative Electron Radiation Therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Disease Free Survival
Recurrence assessments as documented at post-op follow-ups per protcol.
Overall Survival
The length of time from the start of treatment to death within the 5 year period.

Full Information

First Posted
February 11, 2011
Last Updated
May 9, 2022
Sponsor
St. Joseph Hospital of Orange
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1. Study Identification

Unique Protocol Identification Number
NCT01295723
Brief Title
Intraoperative Boost Radiotherapy With Electrons (IOERT) Followed By Hypofractionated Whole-Breast Irradiation (WBRT)
Official Title
Intraoperative Boost Radiotherapy With Electrons (IOERT) Followed By Hypofractionated Whole-Breast Irradiation (WBRT)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2021 (Actual)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Joseph Hospital of Orange

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Lobular and Ductal Carcinoma
Keywords
Breast cancer, Radiation therapy, Mobetron, IOERT, IORT, Hypofractionated radiation therapy, Partial breast radiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intraoperative Electron Radiation Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated Whole Breast Radiation Therapy
Intervention Description
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
Intervention Type
Radiation
Intervention Name(s)
Intraoperative Electron Radiation Therapy
Other Intervention Name(s)
Mobetron
Intervention Description
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
Primary Outcome Measure Information:
Title
Assessment of acute and late toxicity
Description
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
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Cosmetic Evaluation
Description
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.
Time Frame
5 years
Title
Disease Free Survival
Description
Recurrence assessments as documented at post-op follow-ups per protcol.
Time Frame
5 years
Title
Overall Survival
Description
The length of time from the start of treatment to death within the 5 year period.
Time Frame
5 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. All grades G1 - G3 Any hormonal receptor and Her-2 status Informed consent Exclusion Criteria: 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 Karnofsky Index < 70% Mixed connective tissue diseases e.g. rheumatoid polyarthritis, thromboangitis obliterans, systemic lupus. Distant metastases Unable to provide written consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Afshin Forouzannia, M.D.
Organizational Affiliation
The Center for Cancer Prevention & Treatment at St. Joseph Hospital of Orange
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph Hospital of Orange
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States

12. IPD Sharing Statement

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Intraoperative Boost Radiotherapy With Electrons (IOERT) Followed By Hypofractionated Whole-Breast Irradiation (WBRT)

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