Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT)

NCT01960803 | Withdrawn

• 1 other identifier: ACI-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Invasive Ductal Breast Cancer; Carcinoma Breast Stage I

Keywords

Stage I Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month, 3 months, 6 months, 12 months, and then annually for 10 years.

Secondary Outcomes (1)

• 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.

Study Arms (1)

IOERT arm

EXPERIMENTAL

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

Interventions

Intraoperative Electron Radiotherapy RADIATION

Intraoperative Electron Radiotherapy (IOERT) is delivered after completion of the lumpectomy and sentinel node procedure.

IOERT arm

Eligibility Criteria

• Age: 50 Years - 95 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

MeSH Terms

Conditions

Carcinoma, Ductal, Breast; Breast Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Barbara Krueger, MD FACS

  Advocate Health Care - Advocate Christ Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2013
• First Posted: October 11, 2013
• Study Start: May 1, 2013
• Primary Completion: June 3, 2019
• Study Completion: July 5, 2019
• Last Updated: October 4, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)