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

NCT04917640 | Withdrawn

• 1 other identifier: APBI Registry
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of participants with ipsilateral breast recurrence

  Through study completion, an average of 12 months

Study Arms (2)

SBRT

Patients treated with Stereotactic Body Radiation Therapy (SBRT)

Radiation: Radiation Therapy

IMRT

Patients treated with Intensity Modulated Radiation Therapy (IMRT)

Radiation: Radiation Therapy

Interventions

Radiation Therapy RADIATION

Either SBRT or IMRT radiation therapy

IMRT; SBRT

Eligibility Criteria

• Age: 50 Years - 100 Years
• Gender Eligibility Details: Women 50 years old or older who have been diagnosed with low to intermediate DCIS
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Greater than or equal to 50 years old Low to intermediate DCIS Tumor size \< or = to 2cm

You may not qualify if:

• BRCA positive Lobular histology Angiolymphatic invasion

Sponsors & Collaborators

• GenesisCare USA: lead

Study Sites (1)

GenesisCare USA

Stuart, Florida, 34996, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Sharon Salenius, MPH

  Fundacion GenesisCare

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: June 8, 2021
• Study Start: June 1, 2021
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)