RECRUITING

Short Course Vaginal Cuff Brachytherapy in Treating Participants With Stage I-II Endometrial 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 randomized phase III trial studies short course vaginal cuff brachytherapy to see how well it works compared with standard of care vaginal cuff brachytherapy in treating participants with stage I-II endometrial cancer. Short course vaginal cuff brachytherapy, also known as internal radiation therapy, uses (over a shorter period) radioactive material placed directly into or near a tumor in the upper portion of the vagina to kill tumor cells. After completion of cohort 1 (108 participants), the protocol was expended to add a second cohort of 80 additional participants, and re-opened study recruitment.

Official Title

Short Course Adjuvant Vaginal Cuff Brachytherapy (VCB) in Early Endometrial Cancer Compared to Standard of Care (SAVE)

Quick Facts

Study Start:2018-01-30
Study Completion:2029-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03422198

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:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically confirmed endometrial carcinoma: endometrioid type, serous, and clear cell, to include tumors originating in the cervix, but are primarily located in the uterus, and for whom vaginal cuff brachytherapy is indicated. Carcinosarcoma and other sarcomas are permitted; Federation of Gynecology and Obstetrics (FIGO) stage I, with one of the following combinations of stage and grade:
  2. * Stage IA, grade 2, 3
  3. * Stage IB, grades 1-3
  4. * Stage II, grades 1-3
  5. * Stage IIIA, grades 1-3, not receiving EBRT as part of adjuvant therapy.
  6. * Participants post hysterectomy and free from residual disease.
  7. * World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG)-performance status 0-2.
  8. * Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
  9. * Life expectancy of \>2 years.
  1. * Stages of endometrial carcinoma other than described.
  2. * Previous pelvic radiotherapy.
  3. * Interval between the hysterectomy and planned start of radiotherapy exceeding 16 weeks.

Contacts and Locations

Study Contact

Rachel Kingsford
CONTACT
801-585-0115
Rachel.Kingsford@hci.utah.edu

Principal Investigator

Cristina DeCesaris, MD
PRINCIPAL_INVESTIGATOR
Huntsman Cancer Institute/ University of Utah

Study Locations (Sites)

Stanford Cancer Center
Palo Alto, California, 94304
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
MD Anderson
Houston, Texas, 77030
United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
United States
Intermountain Medical Center / LDS Hospital
Salt Lake City, Utah, 84143
United States

Collaborators and Investigators

Sponsor: University of Utah

  • Cristina DeCesaris, MD, PRINCIPAL_INVESTIGATOR, Huntsman Cancer Institute/ University of Utah

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 Date2018-01-30
Study Completion Date2029-10-31

Study Record Updates

Study Start Date2018-01-30
Study Completion Date2029-10-31

Terms related to this study

Additional Relevant MeSH Terms

  • Endometrial Clear Cell Adenocarcinoma
  • Endometrial Endometrioid Adenocarcinoma
  • Endometrial Serous Adenocarcinoma
  • Stage I Uterine Corpus Cancer
  • Stage IA Uterine Corpus Cancer
  • Stage IB Uterine Corpus Cancer
  • Stage II Uterine Corpus Cancer
  • Uterine Corpus Carcinosarcoma
  • Uterine Corpus Sarcoma