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Registry for Intra-Operative Radiotherapy During Breast Conserving Surgery in Patients With Early Stage Breast Cancer

NCT04603209 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2024-04-16

No results posted yet for this study

Summary

This is a prospective, registry study that will enroll all women with early stage breast cancer who will be treated with intraoperative radiotherapy (IORT) during breast-conserving surgery. The purpose of this study is to further validate the long-term effectiveness and safety of this treatment method. We aim to assess short and long-term patient outcomes associated with IORT, including perioperative complications, local and distance disease recurrences, as well as disease-free survival and overall survival.

Conditions

Interventions

RADIATION

Intraoperative Radiation Therapy (IORT)

IORT involving 50kV Xrays to a dose of 20 Gy during breast-conserving surgery

Sponsors & Collaborators

  • Saint John's Cancer Institute

    lead OTHER

Principal Investigators

  • Janie Grumley, MD · John Wayne Cancer Institute, Providence Saint John's Health Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-03
Primary Completion
2028-10-03
Completion
2028-10-03

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04603209 on ClinicalTrials.gov