Toxicity of three-dimensional conformal radiotherapy for accelerated partial breast irradiation.
Jaroslaw T Hepel, Mari Tokita, Stephanie G MacAusland...
https://pubmed.ncbi.nlm.nih.gov/19395195Actively Recruiting
Age: 50Years - 100Years
FEMALE
Healthy Volunteers
ID04985032
Accelerated Partial Breast Irradiation (APBI) Using Stereotactic Body Radiation Therapy (SBRT): a Multicenter, Observational Clinical Trial
Led by RPCR, Inc. · Updated on 2022-08-05
200
Participants Needed
2
Research Sites
145 weeks
Total Duration
On this page
Sponsors
R
RPCR, Inc.
Lead Sponsor
C
CyberKnife Coalition
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the safety and effectiveness of Accelerated Partial Breast Irradiation (APBI) using a specialized radiation technique called Stereotactic Body Radiation Therapy (SBRT) in women with certain types of breast cancer. This observational study focuses on women aged 50 to 100 with low to intermediate grade ductal carcinoma in situ or invasive ductal carcinoma, aiming to assess outcomes over a five-year follow-up period. Participants will receive a targeted radiation dose of 30 Gy divided into five treatments, delivered over alternating days within 5 to 10 days. Before treatment, fiducial markers are placed to guide precise radiation targeting. Imaging techniques such as CT scans, MRI, and PET may be used for motion assessment, and different equipment setups like gantry-based linear accelerators or robotic systems (CyberKnife) are utilized depending on the case. The radiation targets the tumor cavity with defined margins while protecting surrounding organs and tissues. During the study, participants will undergo regular imaging and assessments to monitor breast appearance, acute toxicities within 6 weeks, and late side effects up to 5 years. Researchers will measure cosmetic outcomes using standardized scales and record any adverse events related to treatment. The study includes detailed dosimetry and safety monitoring to evaluate the treatment's impact over time.
CONDITIONS
Brief Title
Accelerated Partial Breast Irradiation (APBI) Using Stereotactic Body Radiation Therapy (SBRT)
Who Can Participate
Age: 50Years - 100Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Women aged 50 years or older
- Low to intermediate grade ductal carcinoma in situ or invasive ductal carcinoma
- Tumor size less than 2 cm for invasive ductal carcinoma and less than 2.5 cm for ductal carcinoma in situ
- Well-defined lumpectomy cavity visible on CT scan
- Clear surgical ink margins greater than 2 mm for invasive cancer and greater than 3 mm for ductal carcinoma in situ
- Node negative status
- Unifocal lesion
- Estrogen receptor (ER) and/or progesterone receptor (PR) positive
- HER-2 negative
- BRCA gene negative
- Lumpectomy cavity must be less than 30% of whole breast volume
You will not qualify if you...
- Lobular histology
- Angiolymphatic invasion
- Multiple foci of disease
- Lymphovascular invasion
- Active lupus or sarcoidosis
- Distant metastases
- Non-epithelial malignancies
- Synchronous contralateral breast cancer
- Grade 2 or higher oncoplastic surgery
- Ipsilateral pacemaker
- Ipsilateral breast implant
- Neoadjuvant chemotherapy
- Prior ipsilateral breast cancer or thoracic radiation
- Poor breast integrity
- Paget's Disease of the nipple
- Pregnant patients
- Severe cardiac, pulmonary, or liver diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to several weeks prior to treatment
Participants who have undergone breast conservation surgery with fiducial markers placed are observed as part of standard care to define the treatment area.
Imaging visits including CT scans with possible MRI and PET as part of simulation
Treatment
Duration - 5 to 10 days
Participants receive stereotactic body radiation therapy (SBRT) consisting of 5 fractions of radiation delivered on alternating days to the breast tumor cavity.
5 treatment visits over 5 to 10 days
Long-term Monitoring
Duration - Up to 60 months
Participants are followed over months to years to assess breast cosmesis, acute and late toxicities, and overall safety after radiation therapy.
Periodic follow-up visits over 2 to 5 years
Trial Site Locations
Total: 2 locations
1
CyberKnife Center of South Florida in Stuart
Stuart, Florida, United States, 33996
Actively Recruiting
2
CyberKnife Centers of Tampa Bay
Tampa, Florida, United States, 33615
Actively Recruiting
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Research Team
M
Mark Perman, MD
D
Debra Freeman, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
Response to "Unacceptable cosmesis in a protocol investigating intensity-modulated radiotherapy with active breathing control for accelerated partial-breast irradiation" (Int J Radiat Oncol Biol Phys 2010;76:71-78) and "Toxicity of three-dimensional conformal radiotherapy for accelerated partial breast irradiation" Int J Radiat Oncol Biol Phys 2009;75:1290-1296).
Norman Wolmark, Walter J Curran, Frank Vicini...
https://pubmed.ncbi.nlm.nih.gov/20394863External beam accelerated partial breast irradiation versus whole breast irradiation after breast conserving surgery in women with ductal carcinoma in situ and node-negative breast cancer (RAPID): a randomised controlled trial.
Timothy J Whelan, Jim A Julian, Tanya S Berrang...
https://pubmed.ncbi.nlm.nih.gov/31813635Long-term primary results of accelerated partial breast irradiation after breast-conserving surgery for early-stage breast cancer: a randomised, phase 3, equivalence trial.
Frank A Vicini, Reena S Cecchini, Julia R White...
https://pubmed.ncbi.nlm.nih.gov/31813636Partial-breast radiotherapy after breast conservation surgery for patients with early breast cancer (UK IMPORT LOW trial): 5-year results from a multicentre, randomised, controlled, phase 3, non-inferiority trial.
Charlotte E Coles, Clare L Griffin, Anna M Kirby...
https://pubmed.ncbi.nlm.nih.gov/28779963Accelerated Partial-Breast Irradiation Compared With Whole-Breast Irradiation for Early Breast Cancer: Long-Term Results of the Randomized Phase III APBI-IMRT-Florence Trial.
Icro Meattini, Livia Marrazzo, Calogero Saieva...
https://pubmed.ncbi.nlm.nih.gov/32840419Reducing the Risk of Secondary Lung Cancer in Treatment Planning of Accelerated Partial Breast Irradiation.
Nienke Hoekstra, Steven Habraken, Annemarie Swaak-Kragten...
https://pubmed.ncbi.nlm.nih.gov/33014782Preliminary Results of a Phase 1 Dose-Escalation Trial for Early-Stage Breast Cancer Using 5-Fraction Stereotactic Body Radiation Therapy for Partial-Breast Irradiation.
Asal Rahimi, Kimberly Thomas, Ann Spangler...
https://pubmed.ncbi.nlm.nih.gov/28586960Cosmetic Outcomes of a Phase 1 Dose Escalation Study of 5-Fraction Stereotactic Partial Breast Irradiation for Early Stage Breast Cancer.
Asal Rahimi, Howard E Morgan, Dong W Kim...
https://pubmed.ncbi.nlm.nih.gov/33476737