Registry for Accelerated Partial Breast Irradiation With (SBRT) or (IMRT)

Breast Cancer Clinical Trial

Official title:

Accelerated Partial Breast Irradiation (PBI) With Stereotactic Body Radiation Therapy (SBRT) or Intensity Modulated Radiation Therapy (IMRT)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04917640
• Other study ID #: APBI Registry
• Status: Withdrawn
• Start date: June 2021
• Est. completion date: December 2024

Study information

• Verified date: June 2021
• Source: GenesisCare USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Gender: Female
• Age group: 50 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Radiation:
• Radiation Therapy
Either SBRT or IMRT radiation therapy

Locations

Country	Name	City	State
United States	GenesisCare USA	Stuart	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GenesisCare USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment and toxicity-related adverse events as assessed by CTCAE v4.0".	Toxicity will be assessed using the CTCAEv4.0 and recorded.	Through study completion, an average of 12 months
Secondary	Number of participants with ipsilateral breast recurrence	Number of participants with pathologically confirmed ipsilateral breast recurrence.	Through study completion, an average of 12 months