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

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Breast Cancer

Treatments: Radiation: 5 Fraction Stereotactic Body Radiation Therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03643861

000521633 (Other Grant/Funding Number)

IRB-300002157

Details and patient eligibility

About

This study offers 5 fractions of radiation treatment through partial breast irradiation in patients with early stage breast cancer after having a lumpectomy.

Full description

This study offers 5 fractions 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 5 doses of 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.
• Inability to clearly delineate lumpectomy cavity on post lumpectomy planning scan.
• Measured maximum PTV of >124cc.
• Lumpectomy cavity within 5mm of body contour.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

5 Fraction Breast Stereotactic Body Radiation Therapy

Experimental group

Description:

This study will enroll patients that have a confirmed histology of early stage breast cancer. The patient will undergo a lumpectomy and will then receive partial breast 5 fractions stereotactic body radiation therapy at a dose of 6 gy for 5 fractions for treatment. Patients will be followed for 36 total months with specific follow-ups at 3, 6, 9, 12, 18, 24, and 36 months.

Treatment:

Radiation: 5 Fraction Stereotactic Body Radiation Therapy