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Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT)

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ClinicalTrials.gov Identifier: NCT01960803
Recruitment Status : Recruiting
First Posted : October 11, 2013
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Barbara Krueger, MD, Advocate Health Care

Brief Summary:
The overall objective of this study is to determine the feasibility and tolerability of single dose Intraoperative Electron Radiation Treatment ("IOERT") as definitive therapy when administered at the time of breast conserving surgery for patients with early stage breast cancer.

Condition or disease Intervention/treatment Phase
Invasive Ductal Breast Cancer Carcinoma Breast Stage I Radiation: Intraoperative Electron Radiotherapy Not Applicable

Detailed Description:

Evaluate local and distant recurrence rates and cosmetic outcomes. Both clinical evaluation of cosmetic outcome by the Surgeon, and subjective impression of cosmetic outcome by the patient, are evaluated using questionnaire.

Local recurrence is evaluated under the same imaging protocol used for Whole breast radiation.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT) As A Single, Full Dose Partial Breast Irradiation For Early Stage, Node Negative, Invasive Breast Cancer
Study Start Date : May 2013
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: IOERT arm
Intraoperative electron radiotherapy (IOERT) is delivered after completion of the lumpectomy and sentinel node procedure. IOERT is performed on a mobile self-shielded magnetron-driven X-band linear accelerator specifically developed for use in the operating room. This machine produces megavoltage electron beams of energy ranging between 4 and 12 MeV. The radiation is delivered from the device to the tumor bed through an attached applicator. A single dose of 21 Gy calculated to the 90% depth posterior to the tumor bed will be administered and will last approximately 2.5 minutes.
Radiation: Intraoperative Electron Radiotherapy
Intraoperative Electron Radiotherapy (IOERT) is delivered after completion of the lumpectomy and sentinel node procedure.




Primary Outcome Measures :
  1. To evaluate change over time on the incidence of local and distance recurrence rates. [ Time Frame: 1 month, 3 months, 6 months, 12 months, and then annually for 10 years. ]
    Subjects will be followed for recurrence rates at one month, three months, six months, twelve months, and then annually for up to 10 years. This will include: history and physical exam, as well as radiographic images at physician discretion and per study protocol.


Secondary Outcome Measures :
  1. To evaluate changes in the short-term and long-term side effects related to IOERT [ Time Frame: 1 month, 3 months, 6 months, 12 months, and then annually for 10 years. ]
    Assessment of the overall patient satisfaction related to the therapy and cosmetic outcome. Cosmesis will be scored by both the physician and patient using the RTOG cosmesis rating system at one month, three months, six months, twelve months, and 24 months. The secondary outcome measure will only take place in the first two years of the 10 year time frame for patient follow up. After 24 month evaluations, patients will only be followed for incidence of local and distance recurrence rates.



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Ages Eligible for Study:   50 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient agrees to breast conservation therapy (segmental resection, partial mastectomy, and radiation therapy) as the treatment for their breast cancer
  • Patient agrees to evaluation of the axilla with sentinel lymph node biopsy
  • Peri or post-menopausal women age > 50, defined as women who have experienced no menstrual period in the past 6 months or more
  • BRCA1 and 2 gene mutation negative, if tested. [genetic testing is NOT required based upon personal or family history]
  • Unifocal (unicentric), invasive ductal carcinoma or favorable sub-types (mucinous, tubular, colloid) < 2.0 cm in diameter, primary T-stage of Tis or T1 (AJCC criteria)
  • Grade 1, 2, or 3 acceptable
  • Associated LCIS is allowed
  • Pure DCIS allowed if <2.5 cm, low to intermediate nuclear grade and resected margins negative at > 3 mm (per ASTRO criteria)
  • Estrogen receptor (ER) status of positive
  • Patient has clear margins >2 mm on gross pathologic examination
  • Patient is node-negative, defined as N0 (i-) or N0 (i+)
  • Patient must be deemed functionally and mentally competent to understand and sign the informed consent
  • Neoadjuvant hormonal therapy is allowed if all other ASTRO suitable criteria have been met prior to onset of hormonal therapy

Exclusion Criteria:

  • Prior breast malignancy or other malignancy if metastatic, or with expected survival of < 5 years
  • Immunocompromised status
  • Pregnancy
  • Women with an active connective tissue disorder (i.e. scleroderma, lupus and others)
  • Breast cancer that involves the skin or chest wall, locally advanced breast cancer
  • Invasive lobular carcinoma
  • Evidence of lymphovascular invasion (LVI)
  • Invasive carcinoma with extensive intraductal component (EIC)
  • Neoadjuvant chemotherapy
  • Patients with 1 or more positive lymph node determined during surgery with sentinel node and/or axillary dissection
  • Someone who is not a candidate for breast conserving management, i.e., prior whole breast radiation therapy

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 ClinicalTrials.gov identifier (NCT number): NCT01960803


Contacts
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Contact: Barbara Krueger, MD FACS 708-346-4055
Contact: Colleen Valenti, RN OCN 708-684-4694 colleen.valenti@advocatehealth.com

Locations
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United States, Illinois
Advocate Christ Medical Center Recruiting
Oak Lawn, Illinois, United States, 60453
Principal Investigator: Barbara Krueger, MD FACS         
Sponsors and Collaborators
Advocate Health Care
Investigators
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Principal Investigator: Barbara Krueger, MD FACS Advocate Health Care - Advocate Christ Medical Center

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Responsible Party: Barbara Krueger, MD, MD, FACS, Advocate Health Care
ClinicalTrials.gov Identifier: NCT01960803     History of Changes
Other Study ID Numbers: ACI-001
First Posted: October 11, 2013    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Barbara Krueger, MD, Advocate Health Care:
Stage I Breast Carcinoma

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