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

August 31, 2021 updated by: GenesisCare USA

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

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Stuart, Florida, United States, 34996
        • GenesisCare USA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with greater than or equal to 50 years old and who have been diagnosed with Low to intermediate DCIS

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with ipsilateral breast recurrence
Time Frame: Through study completion, an average of 12 months
Number of participants with pathologically confirmed ipsilateral breast recurrence.
Through study completion, an average of 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GenesisCare USA

Investigators

  • Study Director: Sharon Salenius, MPH, Fundacion GenesisCare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2021

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

May 24, 2021

First Submitted That Met QC Criteria

June 1, 2021

First Posted (Actual)

June 8, 2021

Study Record Updates

Last Update Posted (Actual)

September 8, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • APBI Registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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