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

May 9, 2022 updated by: St. Joseph Hospital of Orange
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • St. Joseph Hospital of Orange

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intraoperative Electron Radiation Therapy
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.
Radiation: Hypofractionated Whole Breast Radiation Therapy

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
Radiation: Intraoperative Electron Radiation Therapy
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
Other Names:
  • Mobetron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cosmetic Evaluation
Time Frame: 5 years

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Joseph Hospital of Orange

Investigators

  • Principal Investigator: Afshin Forouzannia, M.D., The Center for Cancer Prevention & Treatment at St. Joseph Hospital of Orange

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ACTUAL)

December 1, 2021

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

February 11, 2011

First Submitted That Met QC Criteria

February 11, 2011

First Posted (ESTIMATE)

February 14, 2011

Study Record Updates

Last Update Posted (ACTUAL)

May 11, 2022

Last Update Submitted That Met QC Criteria

May 9, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-003 Mobetron

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Invasive Lobular and Ductal Carcinoma

Clinical Trials on Hypofractionated Whole Breast Radiation Therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe