Five sessions of targeted radiation for early stage breast cancer after surgery
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)
This study is testing if giving five sessions of targeted radiation after breast cancer surgery can work just as well as the usual longer treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT03643861 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and feasibility of administering five fractions of stereotactic body radiotherapy (SBRT) for patients with early stage breast cancer following a lumpectomy. The goal is to determine if this shorter radiation schedule can effectively replace the longer standard treatment regimen. Participants will be monitored for 36 months with follow-up appointments at regular intervals to assess outcomes and any potential side effects.
Who should consider this trial
Good fit: Ideal candidates are women over 50 with early stage invasive breast cancer or ductal carcinoma in situ, who have undergone a lumpectomy.
Not a fit: Patients with multifocal or multicentric cancer or those who have received neoadjuvant chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce treatment time and improve the quality of life for breast cancer patients.
How similar studies have performed: Other studies have explored similar approaches to radiation therapy, but this specific method is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham (UAB) Hazelrig-Salter Radiation Oncology Center (HSROC) — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: D. Hunter Boggs, MD — University of Alabama at Birmingham
- Study coordinator: D. Hunter Boggs, MD
- Email: dhboggs@uabmc.edu
- Phone: (205) 934-5670
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.