Sioux Falls, South Dakota 57105


Purpose:

The purpose of this study is to determine if lumpectomy followed by Intraoperative Electron Radiation Therapy (IOeRT) as a single, full dose partial breast irradiation will have as good or better results in preventing recurrence of local breast cancer, cosmetic appearance and early and late side effects.


Study summary:

See points VIII inclusion/exclusion criteria Operation: - Lumpectomy, steninal node biopsy - IOeRT After Surgery: - Meet with a medical oncologist and discuss if chemotherapy and/or hormone therapy is recommended as part of your treatment course. In some cases, pathology results may indicate the need for removal of additional lymph nodes. The doctor will review pathology and discuss if additional surgery is required. - Chemotherapy (if indicated) - Hormone therapy (if indicated) Follow-Up - Visits will be completed with the surgeon, radiation oncologist and research staff as the protocol indicates. - Assessements of acute toxicity according to CTC-toxicity scoring system - Assessments of late toxicity according to LENT-SOMA scoring systems - Assessment of cosmetic outcome according to scoring system and photo documentation in standardized positions.


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 - Post-menopausal women age > 60, defined as women who have experienced no menstrual period in the past 12 months. - 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 T1 (AJCC criteria) - Grade 1, 2 acceptable - Associated LCIS is allowed - Estrogen receptor (ER) status of positive - Negative margins at ink 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 Exclusion Criteria: - Prior breast malignancy or other malignancy if metastatic, or with expected survival of < 5 years - Immuno-compromised 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 - Pure DCIS, all grades - Invasive lobular carcinoma - Evidence of lymphovascular invasion (LVI) - Invasive carcinoma with extensive intraductal component (EIC) - Neoadjuvant chemotherapy indicated - Patients with 1 or more positive lymph node determined during surgery with sentinel node and/or axillary dissection - Not eligible for breast conserving management, i.e., prior whole breast radiation therapy - Estrogen receptor negative - Her2 positive - Grade 3


NCT ID:

NCT02370797


Primary Contact:

Principal Investigator
Juliann Reiland, MD
Avera Cancer Insitute

Heidi Nickles, MS
Phone: 605-322-3295
Email: heidi.nickles@avera.org


Backup Contact:

Email: cheryl.ageton@avera.org
Cheryl Ageton, RN
Phone: 605-322-3095


Location Contact:

Sioux Falls, South Dakota 57105
United States

Cheryl Ageton, RN
Phone: 605-322-3095
Email: cheryl.ageton@avera.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.