Breast Cancer Clinical Trial

RAD 1802: Pilot Trial of LINAC Based Stereotactic Body Radiotherapy for Early Stage Breast Cancer Patients Eligible for Post-Operative Accelerated Partial Breast Irradiation (APBI)

Summary

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

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Breast Cancer

Estimated Enrollment:

40

Study ID:

NCT03643861

Recruitment Status:

Recruiting

Sponsor:

University of Alabama at Birmingham

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There is 1 Location for this study

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University of Alabama at Birmingham (UAB) Hazelrig-Salter Radiation Oncology Center (HSROC)
Birmingham Alabama, 35233, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

40

Study ID:

NCT03643861

Recruitment Status:

Recruiting

Sponsor:


University of Alabama at Birmingham

How clear is this clinincal trial information?

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