Single vs Hypofractionated Irradiation For Timely Access to Partial Breast Radiotherapy
Recruiting · NCT06885671 · Interventional (participants receive a specific treatment) · Lead sponsor: British Columbia Cancer Agency
View the official record on ClinicalTrials.gov →Interventions studied
Multiple Fraction PBISingle Fraction PBI
What this trial is about
Partial Breast Irradiation (PBI) is a targeted radiation approach commonly administered post-lumpectomy, specifically targeting the tumour bed. This targeted therapy reduces the exposure to other nearby tissues such as lungs, heart, and chest wall. However, traditional PBI treatment involves lengthy multiple fraction courses which presents a burden to patients from rural and remote communities, who must travel long distances to receive high quality cancer care. The purpose of this study is to compare single fraction (SF) PBI vs. multiple fraction (MF) PBI.
Who can take part
Age range
40 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Female participants age 40 or older
- Able to provide informed consent
- pTis-2 pN0 cM0 breast cancer, with tumor size \<3 cm as per provincial guidelines
- Able to complete electronic or paper entry of participant reported outcomes independently or with assistance from caregiver/family/friend/research staff
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
- A history and physical (clinical breast) examination, including ECOG performance status, performed within 8 weeks prior to enrollment.
- Participant is judged able to:
- Maintain a stable position during therapy
- Tolerate immobilization device(s) that may be required to deliver PBI safely
- Negative pregnancy test for People of Child-Bearing Potential (POCBP) within 4 weeks of RT start date
Exclusion criteria
- History of non-breast malignancies except adequately treated non-melanoma skin cancers, in situ cancers treated by local excision or other cancers curatively treated with no evidence of disease for ≥ 5 years.
- Uncontrolled concurrent malignant cancer
- Seroma not visible
- Ipsilateral implanted cardiac device
- Prior radiotherapy requiring summation for planning.
- Requirement for a radiation boost (as determined by the treating investigator)
- Positive surgical margins
- Surgical cavities lacking clear delineation (surgical clips are not required but may assist in target delineation)
- Known germline BRCA1/2 mutation.
- Serious medical comorbidities precluding radiotherapy (e.g., connective tissue disorders such as lupus or scleroderma)
- Pregnant or breastfeeding
Where it is running
1 location listed.
- BC Cancer - Prince George - Prince George, British Columbia, Canada