Clinical trial NCT03643861: 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)
Official title: RAD 1802: a Pilot Trial of Five Fraction Stereotactic Body Radiotherapy for Early Stage Breast Cancer Patients Eligible for Post-Operative Accelerated Partial Breast Irradiation (APBI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: SBRT
Breast cancer
Early stage
Radiation therapy
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Varian Medical Systems
First posted: 2018-08-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

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

Primary outcomes:
measure: Toxicity levels of 5 fractions SBRT for partial breast irradiation assessed by CTCAE v4.0
timeFrame: 0-2 years
Secondary outcomes:
measure: Toxicity of breast SBRT using CTCAE v4.0
timeFrame: 0-2 years
measure: Cosmetic outcome baseline and post-SBRT
timeFrame: 0-2 years
measure: Patient reported outcome baseline and post-SBRT
timeFrame: 0-2 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham (UAB) Hazelrig-Salter Radiation Oncology Center (HSROC)
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: D. Hunter Boggs, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu Y, Veale C, Hablitz D, Krontiras H, Dalton A, Meyers K, Dobelbower M, Lancaster R, Bredel M, Parker C, Keene K, Thomas E, Boggs D. Feasibility and Short-Term Toxicity of a Consecutively Delivered Five Fraction Stereotactic Body Radiation Therapy Regimen in Early-Stage Breast Cancer Patients Receiving Partial Breast Irradiation. Front Oncol. 2022 Jul 8;12:901312. doi: 10.3389/fonc.2022.901312. eCollection 2022.