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

NCT03422198 | Recruiting Phase 3 Results DMC FDA Device

• 2 other identifiers: HCI103841NCI-2018-00011
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 5

Brief 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.

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

Outcome Measures

Primary Outcomes (2)

• Change in Quality of Life From Baseline to 1 Month

  The European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-30 (QLQ-30) is used to evaluate quality of life in cancer patients. The questionnaire was given before and one month following treatment. The quality of life score ranges from 0-100, with higher scores indicating better quality of life. Baseline scores can be found in the Baseline Characteristics module. This outcome reports the average change from baseline to Month 1.

  At 1 month post treatment

• Cohort 2: Participant-Reported Financial Toxicity

  One month post-brachytherapy, participants will be given the Functional Assessment of Chronic Illness Therapy (FACIT) - COmprehensive Score for financial Toxicity (COST) (FACIT-COST) questionnaire. The score range is 0-44, with higher scores indicating better financial well-being. Mean scores will be reported.

  One month after brachytherapy

Secondary Outcomes (5)

• Treatment-related Symptoms on HRQOL Using European Organization for Research and Treatment of Cancer Endometrial Cancer Module (EORTC EN24), Question 48

  one month post-treatment

• USD Amount Charged for Procedures

  Approximately 6 months after treatment

• Cohort 2: Participant-Reported Diet

  One month after brachytherapy

• Cohort 2: Participant-Reported Activity Levels

  One month after brachytherapy

• Cohort 2: Financial Toxicity Correlated With Quality of Life

  One month after brachytherapy

Study Arms (2)

Short course vaginal cuff brachytherapy

EXPERIMENTAL

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

Radiation: Short course vaginal cuff brachytherapy

Vaginal cuff brachytherapy

ACTIVE COMPARATOR

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

Radiation: Vaginal Cuff Brachytherapy

Interventions

Vaginal Cuff Brachytherapy RADIATION

Undergo standard of care vaginal cuff brachytherapy

Also known as: best practice, standard of care, standard therapy

Vaginal cuff brachytherapy

Short course vaginal cuff brachytherapy RADIATION

Undergo short course vaginal cuff brachytherapy

Also known as: BRACHYTHERAPY, internal radiation, Internal Radiation Brachytherapy, Internal Radiation Therapy, Radiation Brachytherapy

Short course vaginal cuff brachytherapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 and stage II, with one of the following combinations of stage and grade:
• Stage IA, grade 1 with LVSI, 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.

You may not qualify if:

• Stages of endometrial carcinoma other than described.
• Previous pelvic radiotherapy.
• Concurrent malignancy requiring non-protocol anti-cancer treatment other than surgery.

Sponsors & Collaborators

• University of Utah: lead
• Huntsman Cancer Institute: collaborator

Study Sites (5)

Stanford Cancer Center

Palo Alto, California, 94304, United States

COMPLETED

Loyola University Medical Center

Maywood, Illinois, 60153, United States

RECRUITING

MD Anderson

Houston, Texas, 77030, United States

RECRUITING

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

Intermountain Medical Center / LDS Hospital

Salt Lake City, Utah, 84143, United States

COMPLETED

Related Publications (34)

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MeSH Terms

Interventions

Practice Guidelines as Topic; Standard of Care; Brachytherapy

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Radiotherapy; Therapeutics

Results Point of Contact

• Title: IIT Data Management Team
• Organization: Research Compliance Office, Huntsman Cancer Institute

IITDataManagement@hci.utah.edu

801-213-6215

Study Officials

• Cristina DeCesaris, MD

  Huntsman Cancer Institute/ University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Kingsford

CONTACT

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

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: February 5, 2018
• Study Start: February 2, 2018
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): October 31, 2029
• Last Updated: December 12, 2025
• Results First Posted: December 23, 2022

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)