Short Course Vaginal Cuff Brachytherapy in Treating Participants With Stage I-II Endometrial 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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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

Short Course Vaginal Cuff Brachytherapy in Treating Participants With Stage I-II Endometrial Cancer

Condition
Endometrial Clear Cell Adenocarcinoma
Intervention / Treatment

-

Contacts and Locations

Palo Alto

Stanford Cancer Center, Palo Alto, California, United States, 94304

Maywood

Loyola University Medical Center, Maywood, Illinois, United States, 60153

Houston

MD Anderson, Houston, Texas, United States, 77030

Salt Lake City

Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States, 84112

Salt Lake City

Intermountain Medical Center / LDS Hospital, Salt Lake City, Utah, United States, 84143

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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:
  • * Stage IA, grade 2, 3
  • * Stage IB, grades 1-3
  • * Stage II, grades 1-3
  • * Stage IIIA, grades 1-3, not receiving EBRT as part of adjuvant therapy.
  • * Participants post hysterectomy and free from residual disease.
  • * World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG)-performance status 0-2.
  • * Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
  • * Life expectancy of \>2 years.
  • * Stages of endometrial carcinoma other than described.
  • * Previous pelvic radiotherapy.
  • * Interval between the hysterectomy and planned start of radiotherapy exceeding 16 weeks.

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Utah,

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

Study Record Dates

2029-10-31