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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

Tracking Information
First Submitted Date  ICMJE September 25, 2013
First Posted Date  ICMJE October 11, 2013
Last Update Posted Date April 11, 2018
Study Start Date  ICMJE May 2013
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 9, 2013)
To evaluate the overall incidence of local and distance recurrence rates. [ Time Frame: 5 years ]
Subjects will be followed at one month, six months, and then once every six months until five years and then yearly up to 10 years.
Change History Complete list of historical versions of study NCT01960803 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2018)
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT)
Official Title  ICMJE Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT) As A Single, Full Dose Partial Breast Irradiation For Early Stage, Node Negative, Invasive Breast Cancer
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Invasive Ductal Breast Cancer
  • Carcinoma Breast Stage I
Intervention  ICMJE Radiation: Intraoperative Electron Radiotherapy
Intraoperative Electron Radiotherapy (IOERT) is delivered after completion of the lumpectomy and sentinel node procedure.
Study Arms  ICMJE 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.
Intervention: Radiation: Intraoperative Electron Radiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 9, 2013)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2023
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Barbara Krueger, MD FACS 708-346-4055
Contact: Colleen Valenti, RN OCN 708-684-4694 colleen.valenti@advocatehealth.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01960803
Other Study ID Numbers  ICMJE ACI-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Barbara Krueger, MD, Advocate Health Care
Study Sponsor  ICMJE Advocate Health Care
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Barbara Krueger, MD FACS Advocate Health Care - Advocate Christ Medical Center
PRS Account Advocate Health Care
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP