TERMINATED

Oncoplastic Partial Mastectomy With Intraoperative Radiation Therapy (IORT) in Early Stage Breast Cancer Patients With Prior History of Chest Wall Radiation.

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

Prospective, Non-randomized, Single-arm.The objectives of this study are to evaluate cosmesis and perioperative complications associated with the use of intraoperative radiotherapy (IORT) at the time of partial mastectomy in patients with breast cancer and a prior history of radiation therapy. Secondary objectives include evaluating effectiveness of partial mastectomy with IORT, measured by local, regional and distant recurrence, mastectomy rate, and disease-specific and overall survival.

Official Title

Oncoplastic Partial Mastectomy With Intraoperative Radiation Therapy (IORT) in Early Stage Breast Cancer Patients With Prior History of Chest Wall Radiation

Quick Facts

Study Start:2021-12-16
Study Completion:2024-10-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT05289466

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:50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 50 y.o.
  2. * Histologically proven in situ and invasive ductal or lobular breast recurrence
  3. * Prior history of whole breast/chest wall radiation therapy
  4. * Disease span ≤ 3 cm, unifocal
  5. * No nodal disease (N0)
  6. * No evidence of metastatic disease (M0)
  7. * Time from initial BCT should be ≥ 1 year
  8. * Patients have refused the standard of care of mastectomy
  9. * Skin distance of ≥ 0.8 cm between applicator and skin
  1. * Multifocal and/or multicenter recurrence
  2. * N1-3 status: Regional cytological or histologically proven node recurrence
  3. * M1 status: Metastatic disease
  4. * cT4 (Skin or muscle involvement) or Paget's disease of the nipple
  5. * Patients undergoing mastectomy
  6. * Patients undergoing neoadjuvant systemic therapy
  7. * Connective tissue disease or scleroderma, contraindicating radiotherapy

Contacts and Locations

Principal Investigator

Janie L Weng Grumley, MD
PRINCIPAL_INVESTIGATOR
Saint John's Cancer Institute

Study Locations (Sites)

Providence Saint John's Hospital
Santa Monica, California, 90404
United States

Collaborators and Investigators

Sponsor: Saint John's Cancer Institute

  • Janie L Weng Grumley, MD, PRINCIPAL_INVESTIGATOR, Saint John's Cancer Institute

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 Date2021-12-16
Study Completion Date2024-10-23

Study Record Updates

Study Start Date2021-12-16
Study Completion Date2024-10-23

Terms related to this study

Additional Relevant MeSH Terms

  • IORT-Intra-Operative Radiation Therapy