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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 5 Fraction Stereotactic Body Radiation Therapy.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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)
Overview
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.
Interventions
- Radiation 5 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 physi
Primary outcome measures
- Toxicity levels of 5 fractions SBRT for partial breast irradiation assessed by CTCAE v4.0 [Time frame: 0-2 years]
Secondary outcome measures (3)
- Toxicity of breast SBRT using CTCAE v4.0 [Time frame: 0-2 years]
- Cosmetic outcome baseline and post-SBRT [Time frame: 0-2 years]
- Patient reported outcome baseline and post-SBRT [Time frame: 0-2 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Alabama at Birmingham (UAB) Hazelrig-Salter Radiation Oncology Center (HSROC — Birmingham
Publications
- 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. PMID 35880164
Identifiers
NCT: NCT03643861 · IRB-300002157 · 000521633