NCT04917640WithdrawnNot Applicable
Accelerated Partial Breast Irradiation (PBI) With Stereotactic Body Radiation Therapy (SBRT) or Intensity Modulated Radiation Therapy (IMRT)
GenesisCare USA1 site in 1 countryStarted: June 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- Number of participants with treatment and toxicity-related adverse events as assessed by CTCAE v4.0".
Study Overview
Brief Summary
This is a registry study that will be used to evaluate external beam radiation therapy methods for the accelerated treatment of breast cancer. Patients are being asked to take part in this registry because they have breast cancer and desire treatment with accelerated partial breast irradiation to be delivered by external beam methods.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 50 Years to 100 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Greater than or equal to 50 years old Low to intermediate DCIS Tumor size < or = to 2cm
Exclusion Criteria
- •BRCA positive Lobular histology Angiolymphatic invasion
Outcomes
Primary Outcomes
Number of participants with treatment and toxicity-related adverse events as assessed by CTCAE v4.0".
Time Frame: Through study completion, an average of 12 months
Toxicity will be assessed using the CTCAEv4.0 and recorded.
Secondary Outcomes
- Number of participants with ipsilateral breast recurrence(Through study completion, an average of 12 months)
Investigators
Study Sites (1)
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