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Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT)

Primary Purpose

Invasive Ductal Breast Cancer, Carcinoma Breast Stage I

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intraoperative Electron Radiotherapy
Sponsored by
Advocate Health Care
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Invasive Ductal Breast Cancer focused on measuring Stage I Breast Carcinoma

Eligibility Criteria

50 Years - 95 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Advocate Christ Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IOERT arm

Arm Description

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.

Outcomes

Primary Outcome Measures

To evaluate change over time on the incidence of local and distance recurrence rates.
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

To evaluate changes in the short-term and long-term side effects related to IOERT
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.

Full Information

First Posted
September 25, 2013
Last Updated
July 23, 2019
Sponsor
Advocate Health Care
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1. Study Identification

Unique Protocol Identification Number
NCT01960803
Brief Title
Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT)
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 Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2013 (undefined)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Advocate Health Care

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Ductal Breast Cancer, Carcinoma Breast Stage I
Keywords
Stage I Breast Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IOERT arm
Arm Type
Experimental
Arm Description
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 Type
Radiation
Intervention Name(s)
Intraoperative Electron Radiotherapy
Intervention Description
Intraoperative Electron Radiotherapy (IOERT) is delivered after completion of the lumpectomy and sentinel node procedure.
Primary Outcome Measure Information:
Title
To evaluate change over time on the incidence of local and distance recurrence rates.
Description
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.
Time Frame
1 month, 3 months, 6 months, 12 months, and then annually for 10 years.
Secondary Outcome Measure Information:
Title
To evaluate changes in the short-term and long-term side effects related to IOERT
Description
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.
Time Frame
1 month, 3 months, 6 months, 12 months, and then annually for 10 years.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Krueger, MD FACS
Organizational Affiliation
Advocate Health Care - Advocate Christ Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT)

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