RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Research Registry for Intra-Operative Radiotherapy (IORT) During Breast Conserving Surgery in Patients With in Situ and Early Stage Breast Cancer

Quick Facts

Study Start:2018-10-03
Study Completion:2028-10-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04603209

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Clinical stage Tis, T1, or T2(≤ 3cm), N0, M0 (AJCC Classification)
  2. * Unifocal Disease
  3. * Candidate for breast-conserving surgery
  4. * Recommended treatment by multidisciplinary team
  1. * Clinical stage T3-4, N1-3, M1
  2. * Multifocal disease

Contacts and Locations

Study Contact

Janie Grumley, MD
CONTACT
(310) 582-7100
janie.grumley@providence.org

Principal Investigator

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

Study Locations (Sites)

John Wayne Cancer Institute, Providence Saint John's Health Center
Santa Monica, California, 90404
United States

Collaborators and Investigators

Sponsor: Saint John's Cancer Institute

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

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 Registration Dates

Study Start Date2018-10-03
Study Completion Date2028-10-03

Study Record Updates

Study Start Date2018-10-03
Study Completion Date2028-10-03

Terms related to this study

Keywords Provided by Researchers

  • Breast Cancer
  • Early-stage Breast Cancer
  • Intraoperative Radiotherapy
  • IORT

Additional Relevant MeSH Terms

  • Early-stage Breast Cancer
  • Breast Carcinoma in Situ
  • Breast Neoplasms