Registry for Accelerated Partial Breast Irradiation With (SBRT) or (IMRT)
Sponsor
GenesisCare USA (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04917640
Collaborator
(none)
0
1
42
0
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
0 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Accelerated Partial Breast Irradiation (PBI) With Stereotactic Body Radiation Therapy (SBRT) or Intensity Modulated Radiation Therapy (IMRT)
Anticipated Study Start Date
:
Jun 1, 2021
Anticipated Primary Completion Date
:
Jun 1, 2024
Anticipated Study Completion Date
:
Dec 1, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| SBRT Patients treated with Stereotactic Body Radiation Therapy (SBRT) |
Radiation: Radiation Therapy
Either SBRT or IMRT radiation therapy
|
| IMRT Patients treated with Intensity Modulated Radiation Therapy (IMRT) |
Radiation: Radiation Therapy
Either SBRT or IMRT radiation therapy
|
Outcome Measures
Primary Outcome Measures
- Number of participants with treatment and toxicity-related adverse events as assessed by CTCAE v4.0". [Through study completion, an average of 12 months]
Toxicity will be assessed using the CTCAEv4.0 and recorded.
Secondary Outcome Measures
- Number of participants with ipsilateral breast recurrence [Through study completion, an average of 12 months]
Number of participants with pathologically confirmed ipsilateral breast recurrence.
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Years
to 100 Years
Sexes Eligible for Study:
Female
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GenesisCare USA | Stuart | Florida | United States | 34996 |
Sponsors and Collaborators
- GenesisCare USA
Investigators
- Study Director: Sharon Salenius, MPH, Fundacion GenesisCare
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
GenesisCare USA
ClinicalTrials.gov Identifier:
NCT04917640
Other Study ID Numbers:
- APBI Registry
First Posted:
Jun 8, 2021
Last Update Posted:
Sep 8, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No