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

Endometrial Serous Adenocarcinoma Clinical Trial

— SAVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03422198
• Other study ID #: HCI103841
• Secondary ID: NCI-2018-00011
• Status: Recruiting
• Phase: Phase 3
• Start date: January 30, 2018
• Est. completion date: October 31, 2029

Study information

• Verified date: February 2024
• Source: University of Utah
• Contact: Cristina DeCesaris, MD
• Phone: 801-585-0255
• Email: Cristina.DeCesaris[@]hci.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

SECONDARY OBJECTIVES:

I. Secondary objectives include evaluation of participant-reported diet and physical activity levels and quality of life 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 188
• Est. completion date: October 31, 2029
• Est. primary completion date: November 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

• 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.

Exclusion Criteria:

• Stages of endometrial carcinoma other than described

• Previous pelvic radiotherapy

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma, Endometrioid
• Carcinosarcoma
• Endometrial Clear Cell Adenocarcinoma
• Endometrial Endometrioid Adenocarcinoma
• Endometrial Neoplasms
• 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

Intervention

Radiation:
• Vaginal Cuff Brachytherapy
Undergo standard of care vaginal cuff brachytherapy
• Short course vaginal cuff brachytherapy
Undergo short course vaginal cuff brachytherapy

Locations

Country	Name	City	State
United States	MD Anderson	Houston	Texas
United States	Loyola University Medical Center	Maywood	Illinois
United States	Stanford Cancer Center	Palo Alto	California
United States	Huntsman Cancer Institute/University of Utah	Salt Lake City	Utah
United States	Intermountain Medical Center / LDS Hospital	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Treatment-related Symptoms on HRQOL Using European Organization for Research and Treatment of Cancer Endometrial Cancer Module (EORTC EN24), Question 48	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.	one month post-treatment
Secondary	USD Amount Charged for Procedures	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.	Approximately 6 months after treatment
Secondary	Cohort 2: Participant-Reported Diet	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.	One month after brachytherapy
Secondary	Cohort 2: Participant-Reported Activity Levels	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.	One month after brachytherapy
Secondary	Cohort 2: Financial Toxicity Correlated With Quality of Life	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.	One month after brachytherapy