RECRUITING

Outcomes and Cosmesis With Whole Breast Irradiation and Boost

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Conditions

Early-stage Breast CancerCosmesisSimultaneous Integrated BoostWhole Breast Irradiation

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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 study is being done to evaluate cosmetic, patient-reported outcome measures (PROMs), and toxicities for women undergoing ultra-short whole breast irradiation (WBI) therapy with simultaneous integrated boost (SIB). 50 participants will be on study for up to 60 months.

Official Title

Patient-Reported Outcomes and Cosmesis Following Five Fraction Whole Breast Irradiation With Simultaneous Integrated Boost

Quick Facts

Study Start:2024-04-17
Study Completion:2032-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06295744

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:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ability to understand and the willingness to sign a written informed consent document
  2. * Histologically confirmed early stage (stage T1-T2) invasive carcinoma of the breast or DCIS
  3. * Breast conserving surgery with negative margins and negative nodes (surgical axillary staging not mandatory), stage N0 or Nx
  4. * Treatment plan should include breast conserving surgery and adjuvant whole breast irradiation (WBI) therapy delivered with 3D-CRT or IMRT techniques
  5. * Treatment plan includes breast tumor bed boost
  6. * Willingness to comply with all study procedures and be available for the duration of the study
  1. * Mastectomy of ipsilateral breast
  2. * Lack of histologic diagnosis
  3. * Histologic involvement of the axillary or regional nodes or metastatic disease
  4. * Accelerated partial breast irradiation treatment plan
  5. * Previous history of non-breast malignancy diagnosed in the past 5 years except for basal or squamous cell cancer of the skin
  6. * Previous history of chest radiation therapy
  7. * Previous history of ipsilateral breast cancer
  8. * Concurrent cytotoxic chemotherapy
  9. * Active connective tissue disease including scleroderma
  10. * Inability or unwillingness to return for required follow up visit

Contacts and Locations

Study Contact

Cancer Connect
CONTACT
800-622-8922
clinicaltrials@cancer.wisc.edu

Principal Investigator

Jessica Schuster, MD
PRINCIPAL_INVESTIGATOR
UW Carbone Cancer Center

Study Locations (Sites)

UW Carbone Cancer Center
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: University of Wisconsin, Madison

  • Jessica Schuster, MD, PRINCIPAL_INVESTIGATOR, UW Carbone Cancer 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 Date2024-04-17
Study Completion Date2032-02

Study Record Updates

Study Start Date2024-04-17
Study Completion Date2032-02

Terms related to this study

Keywords Provided by Researchers

  • Cosmesis
  • Simultaneous Integrated Boost
  • Whole Breast Irradiation

Additional Relevant MeSH Terms

  • Early-stage Breast Cancer