Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT)

Invasive Ductal Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01960803
• Other study ID #: ACI-001
• Status: Completed
• Phase: N/A
• Start date: May 1, 2013
• Est. completion date: July 1, 2019

Study information

• Verified date: July 2019
• Source: Advocate Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 95 Years

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

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma Breast Stage I
• Carcinoma, Ductal, Breast
• Invasive Ductal Breast Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Advocate Christ Medical Center	Oak Lawn	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Advocate Health Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1 month, 3 months, 6 months, 12 months, and then annually for 10 years.