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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by St. Joseph Hospital of Orange
Sponsor:
Information provided by (Responsible Party):
St. Joseph Hospital of Orange
ClinicalTrials.gov Identifier:
NCT01295723
First received: February 11, 2011
Last updated: September 17, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Invasive Lobular and Ductal Carcinoma
Radiation: Hypofractionated Whole Breast Radiation Therapy
Radiation: Intraoperative Electron Radiation Therapy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intraoperative Boost Radiotherapy With Electrons (IOERT) Followed By Hypofractionated Whole-Breast Irradiation (WBRT)

Resource links provided by NLM:


Further study details as provided by St. Joseph Hospital of Orange:

Primary Outcome Measures:
  • Assessment of acute and late toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 5 years ] [ Designated as safety issue: No ]

    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 [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2011
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Mobetron

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01295723

Locations
United States, California
St. Joseph Hospital of Orange Recruiting
Orange, California, United States, 92868
Contact: Nancy Walter    714-734-6220      
Contact: Gitana Davila    714-734-6220 ext 41477    Gitana.Davila@stjoe.org   
Principal Investigator: Afshin Forouzannia, M.D.         
Sub-Investigator: Robert Ash, M.D.         
Sub-Investigator: Venita Williams, M.D.         
Sub-Investigator: Jay Harness, M.D.         
Sub-Investigator: Michele Carpenter, M.D.         
Sponsors and Collaborators
St. Joseph Hospital of Orange
Investigators
Principal Investigator: Afshin Forouzannia, M.D. The Center for Cancer Prevention & Treatment at St. Joseph Hospital of Orange
  More Information

No publications provided

Responsible Party: St. Joseph Hospital of Orange
ClinicalTrials.gov Identifier: NCT01295723     History of Changes
Other Study ID Numbers: 11-003 Mobetron
Study First Received: February 11, 2011
Last Updated: September 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by St. Joseph Hospital of Orange:
Breast cancer
Radiation therapy
Mobetron
IOERT
IORT
Hypofractionated radiation therapy
Partial breast radiation

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Ductal, Breast
Carcinoma, Lobular
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Ductal
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 20, 2014