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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03643861
Other study ID # IRB-300002157
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 20, 2019
Est. completion date December 2023

Study information

Verified date November 2021
Source University of Alabama at Birmingham
Contact Kristin Webb, CCRP
Phone (205) 975-9316
Email kkwebb@uabmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study offers single fraction radiation treatment through partial breast irradiation in patients with early stage breast cancer after having a lumpectomy.


Description:

This study offers single fraction stereotactic body radiotherapy for early stage breast cancer after patient undergoes a lumpectomy. The study aims to determine the safety and feasibility of delivering only a single higher dose radiation treatment rather than the longer schedule of treatments that is currently considered standard of care for breast cancer patients. Patients will be followed for 36 months (2 years) with follow-up appointments at 6, 12, 18, 24, and 36 months.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Pathologically proven invasive mammary carcinoma, Invasive ductal carcinoma (IDC) or ductal carcinoma in situ (DCIS) of the breast. Medullary, papillary, mucinous (colloid) and tubular histologies are allowed. - Age>50. - Maximum pathologic tumor size <2.0cm if invasive carcinoma or < 2.5cm if pure DCIS. - Estrogen receptor (ER) positive (>10%). - Must be eligible for breast conservation therapy and receive a lumpectomy with pathologic margins of at least 2mm. - Must be clinically node negative by physical examination. Sentinel node dissection is not required, but if undertaken, the patient must be pathologically node negative. - Zubrod Performance Status 0-2. Exclusion Criteria: - Multifocal or multicentric cancer. - Reception of neoadjuvant chemotherapy. - Pure invasive lobular histology. - Surgical margins<2mm. - Inability to clearly delineate lumpectomy cavity on post lumpectomy planning scan. - Measured maximum PTV of >124cc. - Lumpectomy cavity within 5mm of body contour.

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
Single Fraction Stereotactic Body Radiation Therapy
Stereotactic body radiation therapy (SBRT) has gained favor in the treatment of select central nervous system, lung, and abdominal malignancies due to its ability to deliver highly conformal doses of radiotherapy while using sharp dose gradients to deliver comparatively lower doses to the surrounding normal tissue. Utilization of SBRT is more labor intensive than conventional fractionation and requires precise immobilization and localization techniques with daily image guidance with direct physician and physicist oversight for all treatments. While more labor intensive and often utilizing more advanced technologies, SBRT allows the advantage of reducing setup margins compared to conventionally fractionated treatment while being able to shorten overall treatment times due to the ability to safely dose escalate high risk areas

Locations

Country Name City State
United States University of Alabama at Birmingham (UAB) Hazelrig-Salter Radiation Oncology Center (HSROC) Birmingham Alabama

Sponsors (1)

Lead Sponsor Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Toxicity levels of single fraction SBRT for partial breast irradiation assessed by CTCAE v4.0 To determine the safety of single fraction SBRT for patients with early stage breast cancer after a lumpectomy. Safety will be determined by CTCAE v4.0 and access toxicity, or lack of, experienced by patients enrolled in this study. 0-2 years
Secondary Toxicity of breast SBRT using CTCAE v4.0 To define the acute (<90 days) and late toxicity (>90 days) up to two years after breast SBRT (CTCAE 4) attributable to therapy. 0-2 years
Secondary Cosmetic outcome post-SBRT To determine patient and nurse assessed cosmetic outcome at 1, 6, 12, 18, 24, and 36 months post SBRT. Patient will give a verbal satisfaction rating of 1-Excellent, 2-Good, 3-Fair, or 4-Poor of their cosmetic appearance post-SBRT. Nurse will also give their overall rating of 1-Excellent, 2-Good, 3-Fair, or 4-Poor based off of their examination of the cosmetic appearance post-SBRT. 0-2 years
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