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IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry

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: NCT03536897
Recruitment Status : Recruiting
First Posted : May 25, 2018
Last Update Posted : February 25, 2020
Information provided by (Responsible Party):
Malolan Rajagopalan, Mount Carmel Health System

Brief Summary:
This is a prospective, registry trial which will enroll women aged 65 and above with early stage, low risk breast cancer who will be treated with partial mastectomy and intraoperative radiation therapy (IORT). The primary aim is to determine the 5-year risk of in-breast tumor recurrence. Secondary aims include identification of acute- and late-toxicity, cosmetic result, disease-free survival and overall survival.

Condition or disease Intervention/treatment
Breast Cancer Radiation: IORT

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 168 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Intraoperative Radiation Therapy (IORT) Following Breast Conserving Surgery for Early Stage Breast Cancer Registry
Actual Study Start Date : February 27, 2018
Estimated Primary Completion Date : February 27, 2028
Estimated Study Completion Date : February 27, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
All patients will undergo a partial mastectomy with sentinel lymph node biopsy with the goal of achieving a margin-negative resection while maintaining good cosmetic outcome. Immediately following partial mastectomy and frozen section evaluation of the sentinel lymph nodes, IORT is to be delivered. Intraoperative radiation therapy will involve 50 kV xrays to a dose of 20 Gy during breast conserving surgery. After surgery, patients are followed based on the standard schedule determined by their surgeon for 5 years.
Radiation: IORT
Intraoperative radiation therapy with INTRABEAM system to a dose of 20 Gy

Primary Outcome Measures :
  1. In-Breast Tumor Recurrence (IBTR) [ Time Frame: 5 years ]
    Ipsilateral In-Breast Tumor Recurrence (IBTR): defined as biopsy-proved invasive or in situ breast cancer (except LCIS) in the ipsilateral breast.

Secondary Outcome Measures :
  1. Late Toxicity [ Time Frame: 5 years ]

    Degree of late radiation toxicity will be scored based upon RTOG/EORTC (Radiation Therapy Oncology Group/Eastern Oncology Radiation Therapy Consortium) late radiation morbidity scoring schema for subcutaneous tissue as well as cosmetic result.

    The RTOG/EORTC late radiation morbidity scoring schema on subcutaneous tissue is as follows:

    • GRADE 1: Slight induration (fibrosis) and loss of subcutaneous fat
    • GRADE 2: Moderate fibrosis but asymptomatic; slight field contracture; <10% linear reduction
    • GRADE 3: Severe induration and loss of subcutaneous tissue; field contracture > 10% linear measurement
    • GRADE 4: Necrosis

  2. Acute Toxicity [ Time Frame: 3 months ]

    Acute radiation toxicity will be scored at the first follow-up visit after IORT (4-6 weeks after treatment).

    Radiation dermatitis will be scored based upon CTCAE (Common Terminology Criteria for Adverse Events) v4.03 scale as follows:

    • GRADE 1: Faint erythema or dry desquamation
    • GRADE 2: Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema
    • GRADE 3: Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion
    • GRADE 4: Life threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated

    Other acute toxicity will also be scored per the CTCAE v4.03 scale and will be rated on the relation to radiation therapy (definitely related, probably related, possibly related, unlikely related, unrelated)

  3. Disease Free Survival [ Time Frame: 5 yeras ]
    Disease Free Survival

  4. Overall Survival [ Time Frame: 5 years ]
    Overall Survival

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women aged 65 and above with early stage breast cancer, ER+, low to intermediate grade invasive ductal carcinoma of the breast amenable to breast conserving surgery and radiation therapy.

Inclusion Criteria:

  • Female
  • ECOG performance status 0-1
  • Age 65 years or older
  • cT1 or cT2 (≤3.0 cm)
  • Invasive ductal carcinoma histology
  • Estrogen receptor positive (ER+)
  • Grade 1 or Grade 2
  • Clinically negative lymph nodes (cN0) by examination, imaging and/or nodal sampling
  • Suitable for breast conserving surgery and radiation therapy
  • Patient must be able to provide study-specific informed consent

Exclusion Criteria:

  • Multi-centric cancer not amenable to single lumpectomy
  • Prior ipsilateral whole breast radiation
  • Known BRCA 1 or BRCA 2 mutation
  • Status post neoadjuvant hormonal or chemotherapy
  • Invasive lobular histology
  • Pure ductal carcinoma in situ (DCIS)
  • Grade 3
  • Diffuse suspicious microcalcifications

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): NCT03536897

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Contact: Lynn Shaffer, PhD 614-234-3625

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United States, Ohio
Mount Carmel West Hospital Recruiting
Columbus, Ohio, United States, 43222
Contact: Malolan S Rajagopalan, MD    614-234-5402   
Sponsors and Collaborators
Mount Carmel Health System
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Principal Investigator: Malolan Rajagopalan, MD Mount Carmel Health System
Additional Information:

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Responsible Party: Malolan Rajagopalan, Principal Investigator, Mount Carmel Health System Identifier: NCT03536897    
Other Study ID Numbers: 180212-1
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Malolan Rajagopalan, Mount Carmel Health System:
breast cancer
invasive ductal carcinoma
intraoperative radiation therapy
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases