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

Last updated: September 3, 2024
Sponsor: University of Utah
Overall Status: Active - Recruiting

Phase

3

Condition

Endometrial Cancer

Adenocarcinoma

Treatment

Vaginal Cuff Brachytherapy

Short course vaginal cuff brachytherapy

Clinical Study ID

NCT03422198
HCI103841
NCI-2018-00011
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically confirmed endometrial carcinoma: endometrioid type, serous, and clearcell, to include tumors originating in the cervix, but are primarily located in theuterus, and for whom vaginal cuff brachytherapy is indicated. Carcinosarcoma andother sarcomas are permitted; Federation of Gynecology and Obstetrics (FIGO) stageI, 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 thatconforms to federal and institutional guidelines.

  • Life expectancy of >2 years.

Exclusion

Exclusion Criteria:

  • Stages of endometrial carcinoma other than described.

  • Previous pelvic radiotherapy.

  • Interval between the hysterectomy and planned start of radiotherapy exceeding 16weeks.

Study Design

Total Participants: 188
Treatment Group(s): 2
Primary Treatment: Vaginal Cuff Brachytherapy
Phase: 3
Study Start date:
January 30, 2018
Estimated Completion Date:
October 31, 2029

Study Description

PRIMARY OBJECTIVES:

I. Evaluate the non-inferiority of participant health related quality of life (HRQOL) using the Global Health Score from the Quality of Life Questionnaire Core 30 (QLQ-C30) in the 2 arms one month after treatment.

SECONDARY OBJECTIVES:

I. Compare treatment-related symptoms on HRQOL using European Organization for Research and Treatment of Cancer Endometrial Cancer Module (EORTC EN24), question 48 between the two treatment arms.

II. Compare cost effectiveness between the two treatment arms.

TERTIARY OBJECTIVES:

I. Report vaginal, bowel, and bladder symptoms on HRQOL using the EORTC EN24 the two treatment arms.

II. Evaluate toxicities between the two treatment arms.

III. Compare local recurrence and document patterns of recurrence between the two treatment arms. There will be two analyses: A single interim evaluation of patterns of recurrence will be performed after a minimum of 75 participants have been accrued, and the second evaluation will be performed at the end of the study.

IV. Evaluate and compare doses to organs at risk (bladder, rectum, sigmoid colon, and urethra) and the prescribed target in the two arms.

V. Compare total distance traveled to the cancer center for study related visits.

OUTLINE: Participants are randomized to 1 of 2 arms.

Arm I: Participants undergo short course vaginal cuff brachytherapy for 2 fractions with 1 week apart.

Arm II: Participants undergo standard of care vaginal cuff brachytherapy for 3-5 fractions over no more than 3 weeks.

After completion of study treatment, participants are followed up at 1, 6, and 12 months.

COHORT 2 (PILOT EXPANSION)

PRIMARY OBJECTIVES:

I. The primary objective is to evaluate the frequency and severity of participant-reported financial toxicity in participants with early-stage endometrial cancer treated with vaginal cuff-brachytherapy (VCB) at one-month post-VCB.

EXPLORATORY OBJECTIVES:

I. Exploratory objectives will include evaluation of differences in participant-reported financial toxicity, between cohorts, to assess any impact of treatment duration on outcomes.

II. Exploratory objectives include evaluation of patient-reported diet and physical activity levels and quality of life in patients with early-stage endometrial cancer treated with vaginal cuff-brachytherapy (VCB) at one-month post-VCB.

Connect with a study center

  • Stanford Cancer Center

    Palo Alto, California 94304
    United States

    Completed

  • Loyola University Medical Center

    Maywood, Illinois 60153
    United States

    Completed

  • MD Anderson

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

  • Intermountain Medical Center / LDS Hospital

    Salt Lake City, Utah 84143
    United States

    Completed

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