Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT)

Not Applicable

Withdrawn

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
IOERT arm	Intraoperative Electron Radiotherapy	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.

Primary Outcome Measures

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

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

Locations (1): Advocate Christ Medical Center
🇺🇸
Oak Lawn, Illinois, United States