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Single Fraction Intraoperative Radiotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01688388
Recruitment Status : Recruiting
First Posted : September 19, 2012
Last Update Posted : October 16, 2014
Information provided by (Responsible Party):
St. Joseph Hospital of Orange

Brief Summary:
This clinical trial is being conducted to find out the effects (good and bad) of giving the full radiation treatment for breast cancer as a single dose of radiation during surgery for breast cancer. This single fraction intraoperative radiotherapy with electrons will study the toxicity, local control and cosmetic outcome.

Condition or disease Intervention/treatment Phase
Invasive Ductal and Invasive Lobular Breast Carcinoma Stage 0 Breast Carcinoma Stage I Breast Carcinoma Stage II Breast Carcinoma Procedure: Intraoperative Radiotherapy Phase 1 Phase 2

Detailed Description:
For patients with certain types of breast cancer, one standard treatment is breast conserving surgery or lumpectomy (surgery to remove abnormal tissue or cancer from the breast 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 followed by 5-8 daily localized irradiation (or boost) treatments at the site where the lump was removed. During this study, the single dose of electron irradiation given at the surgical site during the operation will replace the radiation given after surgery.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Fraction Intraoperative Radiotherapy With Electrons: An Option in Breast-Conserving Operable Breast Cancer Stages 0, I and II - Prospective, Single-arm Trial
Study Start Date : February 2012
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: IORT Arm
Intraoperative radiotherapy (IORT) is delivered after completion of the lumpectomy and sentinel node procedure.
Procedure: Intraoperative Radiotherapy
Intraoperative radiotherapy (IORT) is delivered after completion of the lumpectomy and sentinel node procedure. IORT is performed on mobile or fixed linacs with variable electron energies in the range of 6-12 MeV prescribed to a dose of 21 Gy, with the prescription dose covering at least 90% of the Planning Target Volume (PTV). PTV is defined as a 3D volume of 1-2 cm beyond the former macroscopic tumor edge (excluding skin, limit to anterior rib surface: 5 Gy). The choice of electron energy as well as the cone applicator size has to account for minimum PTV requirements. Tissue depth measurement will be documented by intraoperative sonography.
Other Name: IORT

Primary Outcome Measures :
  1. Toxicity Assessment [ Time Frame: 5 years ]

    Assessment of acute toxicity of breast irradiation according to CTC-toxicity Scoring - system:

    • End of initial surgical phase: Week 1, 4
    • First Follow-up investigation: Month 2 Assessment of late toxicity according to NSABP scoring-systems at 6, 12, 24, 36, 48, and 60 months

Secondary Outcome Measures :
  1. Cosmetic Evaluation [ Time Frame: 5 years ]

    Assessment of cosmetic outcome according to 5-point scoring system

    • Week 1, 2; Month 2, 6, 12, 24, 36, 48, 60
    • At yearly follow-up (photodocumentation in standardized positions) for 5 years

  2. Recurrence Assessment [ Time Frame: 5 years ]
    Recurrence is assessed at month 6, 12, 24, 36, 48, 60

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Ages Eligible for Study:   41 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histological proven invasive breast carcinoma ductal, lobular and/or Ductal Carcinoma in situ
  • Age > 40 years
  • Karnofsky performance status > 70%
  • Tumor. 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 equal to or less than 2.5 cm
  • Nodal Status: preoperatively N0
  • Clear surgical margins: R0
  • All grades G1 - G3
  • Any hormonal receptor and HER-2 status
  • Informed consent

Exclusion Criteria:

  • Gender: male
  • Tumor size: more than 2.5 cm
  • Nodal status greater than or equal to N1 pathologically
  • Multicentricity
  • Previous radiotherapy to the involved breast
  • Karnofsky Index < 70%
  • Mixed connective tissue diseases e.g. rheumatoid poly arthritis, thromboangitis obliterans, systemic lupus
  • Distant metastases
  • Pregnancy in woman of child bearing age
  • Unable to provide written consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01688388

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Contact: Heather Weiss, BS 714-734-6220 ext 40838
Contact: Carmen Moronez

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United States, California
St. Joseph Hospital of Orange Recruiting
Orange, California, United States, 92868
Contact: Heather Weiss, BS    714-734-6220 ext 40838   
Contact: Carmen Moronez         
Principal Investigator: Afshin Forouzannia, M.D.         
Sponsors and Collaborators
St. Joseph Hospital of Orange
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Study Chair: Lawrence Wagman, M.D. St. Joseph Hospital of Orange

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Responsible Party: St. Joseph Hospital of Orange Identifier: NCT01688388     History of Changes
Other Study ID Numbers: 12-001 Single Fraction IORT
First Posted: September 19, 2012    Key Record Dates
Last Update Posted: October 16, 2014
Last Verified: October 2014

Keywords provided by St. Joseph Hospital of Orange:
Breast Cancer
Intraoperative Radiotherapy

Additional relevant MeSH terms:
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Breast Neoplasms
Carcinoma, Lobular
Breast Carcinoma In Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplasms, Ductal, Lobular, and Medullary
Carcinoma in Situ