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

Phase 3

Recruiting

• Conditions: Endometrial Clear Cell Adenocarcinoma; Uterine Corpus Carcinosarcoma; Stage I Uterine Corpus Cancer; Endometrial Endometrioid Adenocarcinoma; Stage IB Uterine Corpus Cancer; Uterine Corpus Sarcoma; Endometrial Serous Adenocarcinoma; Stage IA Uterine Corpus Cancer; Stage II Uterine Corpus Cancer
• Interventions: Radiation: Short course vaginal cuff brachytherapy; Radiation: Vaginal Cuff Brachytherapy

• Registration Number: NCT03422198
• Lead Sponsor: University of Utah

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.

Detailed 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, dietary, and physical activity habits 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.

Study Timeline

• Study First Submitted: 2018-01-16
• Study Start: 2018-01-30
• Study First Submitted QC: 2018-02-02
• Study First Posted: 2018-02-05
• Results First Submitted: 2022-12-02
• Results First Submitted QC: 2022-12-02
• Results First Posted: 2022-12-23
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-28
• Primary Completion: 2026-11-30
• Study Completion: 2029-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 188

Inclusion 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.

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Exclusion Criteria

• Stages of endometrial carcinoma other than described.
• Previous pelvic radiotherapy.
• Interval between the hysterectomy and planned start of radiotherapy exceeding 16 weeks.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Short course vaginal cuff brachytherapy	Short course vaginal cuff brachytherapy	Participants undergo short course vaginal cuff brachytherapy for 2 fractions with 1 week apart.
Vaginal cuff brachytherapy	Vaginal Cuff Brachytherapy	Participants undergo standard of care vaginal cuff brachytherapy for 3-5 fractions over no more than 3 weeks.

Primary Outcome Measures

Name	Time	Method
Cohort 2: Participant-Reported Financial Toxicity	One month after brachytherapy	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.
Change in Quality of Life From Baseline to 1 Month	At 1 month post treatment	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.

Secondary Outcome Measures

Name	Time	Method
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	The European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Endometrial-24 (QLQ-EN24) was used to evaluate quality of life in cancer patients with endometrial cancers. The questionnaire was given before and one month following treatment. From this assessment, one question was selected as an indicator for this outcome, which measured whether participants felt less feminine as a result of their disease or treatment. The score ranges from 0-100, with higher scores indicating feeling less feminine. Baseline scores can be found in the Baseline Characteristics module. This outcome reports the average change from baseline to Month 1.
USD Amount Charged for Procedures	Approximately 6 months after treatment	The amount charged to participants or their insurance in US Dollars (USD) was collected to evaluate cost of experimental versus standard of care courses of treatment. Data was collected at approximately six months after treatment.
Cohort 2: Financial Toxicity Correlated With Quality of Life	One month after brachytherapy	Mean scores from the FACIT-COST (from Outcome Measure 2: Participant-Reported Financial Toxicity) will be correlated with mean QoL scores (from Outcome Measure 1). Additional information about the methods and measurements will be updated when results are reported for this outcome.
Cohort 2: Participant-Reported Diet	One month after brachytherapy	Participants will be asked to complete the National Cancer Institute (NCI) Diet History Questionnaire 3 (DHQIII) through the NCI website. Additional information about the questionnaire, methods, and measurements will be updated when results are reported for this outcome.
Cohort 2: Participant-Reported Activity Levels	One month after brachytherapy	Participants will be asked to complete the NCI Activities Completed over Time in 24-hours (ACT24) questionnaire through the NCI website. Additional information about the questionnaire, methods, and measurements will be updated when results are reported for this outcome.

Trial Locations

Locations (5)

MD Anderson; 🇺🇸 Houston, Texas, United States

Huntsman Cancer Institute/University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Stanford Cancer Center; 🇺🇸 Palo Alto, California, United States

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States

Intermountain Medical Center / LDS Hospital; 🇺🇸 Salt Lake City, Utah, United States