Expired Study
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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


Study is Available At:


Original ID:

ACI-1450-IOERTSFX


NCT ID:

NCT02370797


Secondary ID:


Study Acronym:


Brief Title:

Node Negative, Invasive Breast Cancer Single Fraction 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


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

Female


Minimum Age:

60 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Avera McKennan Hospital & University Health Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

100


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Juliann Reiland, MD
Principal Investigator
Avera Cancer Insitute

Study Dates

Start Date:February 2015
Completion Date:May 2029
Completion Type:Anticipated
Primary Completion Date:February 2029
Primary Completion Type:Anticipated
Verification Date:June 2019
Last Changed Date:July 17, 2019
First Received Date:February 3, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Proportion of patients who are free of breast cancer.
Time Frame:10 years
Safety Issues:False
Description:Patients will be followed by standard of care breast imaging along with appointments with breast surgeon, radiation oncologist and medical oncologist if indicated.
Outcome Type:Secondary Outcome
Measure:Local recurrance rate with acute toxicity and cosmetic evaluations
Time Frame:10 years
Safety Issues:False
Description:AEs and Lent Soma will be assessed for acute toxicity. We will use a 20% toxicity cutoff, the protocol would be stopped if 2/10 were determined to have developed significant toxicities, grade 3 or greater, at the first 6-month follow-up visit. 2/10 patien

Study Interventions

Intervention Type:Radiation
Name:Single Fraction IOeRT
Description:A single dose of 21 Gy calculated such that the 90% isodose line encompasses the posterior of the tumor bed will be administered.
Arm Name:Single Fraction IOeRT
Other Name:Intra-Operative electron radiation therapy

Study Arms

Study Arm Type:Experimental
Arm Name:Single Fraction IOeRT
Description:A single dose of 21 Gy calculated such that the 90% isodose line encompasses the posterior of the tumor bed will be administered.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Avera McKennan Hospital & University Health Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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