Trial Outcomes & Findings for Short Course Vaginal Cuff Brachytherapy in Treating Participants With Stage I-II Endometrial Cancer (NCT NCT03422198)

Last Updated: 2025-12-12

Results Overview

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.

Recruitment status

RECRUITING

Study phase

PHASE3

Target enrollment

188 participants

Primary outcome timeframe

At 1 month post treatment

Results posted on

2025-12-12

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental: Short Course Vaginal Cuff Brachytherapy Participants undergo short course vaginal cuff brachytherapy for 2 fractions with 1 week apart.	Control: Standard of Care Vaginal Cuff Brachytherapy Participants undergo standard of care vaginal cuff brachytherapy for 3-5 fractions over no more than 3 weeks.
Overall Study COMPLETED	54	54
Overall Study STARTED	54	54
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The primary outcome related to this baseline measure requires participants to have completed both the baseline and Month 1 assessments to be included. Participants without both were excluded in this baseline measure. Five control arm participants did not complete the Month 1 questionnaire. One control arm participant did not complete the baseline questionnaire. Two experimental arm participants did not complete the Month 1 questionnaire.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental: Short Course Vaginal Cuff Brachytherapy n=54 Participants Participants undergo short course vaginal cuff brachytherapy for 2 fractions with 1 week apart.	Control: Standard of Care Vaginal Cuff Brachytherapy n=54 Participants Participants undergo standard of care vaginal cuff brachytherapy for 3-5 fractions over no more than 3 weeks.	Total n=108 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=54 Participants	0 Participants n=54 Participants	0 Participants n=108 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=54 Participants	31 Participants n=54 Participants	53 Participants n=108 Participants
Age, Categorical >=65 years	32 Participants n=54 Participants	23 Participants n=54 Participants	55 Participants n=108 Participants
Age, Continuous	66.5 years n=54 Participants	63.5 years n=54 Participants	65 years n=108 Participants
Sex: Female, Male Female	54 Participants n=54 Participants	54 Participants n=54 Participants	108 Participants n=108 Participants
Sex: Female, Male Male	0 Participants n=54 Participants	0 Participants n=54 Participants	0 Participants n=108 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=54 Participants	6 Participants n=54 Participants	11 Participants n=108 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=54 Participants	48 Participants n=54 Participants	94 Participants n=108 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=54 Participants	0 Participants n=54 Participants	3 Participants n=108 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=54 Participants	1 Participants n=54 Participants	1 Participants n=108 Participants
Race (NIH/OMB) Asian	0 Participants n=54 Participants	0 Participants n=54 Participants	0 Participants n=108 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=54 Participants	0 Participants n=54 Participants	0 Participants n=108 Participants
Race (NIH/OMB) Black or African American	5 Participants n=54 Participants	5 Participants n=54 Participants	10 Participants n=108 Participants
Race (NIH/OMB) White	41 Participants n=54 Participants	45 Participants n=54 Participants	86 Participants n=108 Participants
Race (NIH/OMB) More than one race	1 Participants n=54 Participants	1 Participants n=54 Participants	2 Participants n=108 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=54 Participants	2 Participants n=54 Participants	9 Participants n=108 Participants
Baseline EORTC Quality of Life Score	72.28 score on a scale STANDARD_DEVIATION 21.5 • n=52 Participants • The primary outcome related to this baseline measure requires participants to have completed both the baseline and Month 1 assessments to be included. Participants without both were excluded in this baseline measure. Five control arm participants did not complete the Month 1 questionnaire. One control arm participant did not complete the baseline questionnaire. Two experimental arm participants did not complete the Month 1 questionnaire.	67.88 score on a scale STANDARD_DEVIATION 21.74 • n=48 Participants • The primary outcome related to this baseline measure requires participants to have completed both the baseline and Month 1 assessments to be included. Participants without both were excluded in this baseline measure. Five control arm participants did not complete the Month 1 questionnaire. One control arm participant did not complete the baseline questionnaire. Two experimental arm participants did not complete the Month 1 questionnaire.	70.17 score on a scale STANDARD_DEVIATION 21.26 • n=100 Participants • The primary outcome related to this baseline measure requires participants to have completed both the baseline and Month 1 assessments to be included. Participants without both were excluded in this baseline measure. Five control arm participants did not complete the Month 1 questionnaire. One control arm participant did not complete the baseline questionnaire. Two experimental arm participants did not complete the Month 1 questionnaire.
Baseline EORTC Symptom Score	10.46 score on a scale STANDARD_DEVIATION 26.24 • n=51 Participants • The secondary outcome related to this baseline measure requires participants to have completed both baseline and Month 1 questionnaires to be included. Participants who did not complete both were excluded. Five control arm participants did not complete the Month 1 questionnaire. One control arm participant did not complete the baseline questionnaire. Three experimental arm participants did not complete the Month 1 questionnaire.	16.67 score on a scale STANDARD_DEVIATION 28.35 • n=48 Participants • The secondary outcome related to this baseline measure requires participants to have completed both baseline and Month 1 questionnaires to be included. Participants who did not complete both were excluded. Five control arm participants did not complete the Month 1 questionnaire. One control arm participant did not complete the baseline questionnaire. Three experimental arm participants did not complete the Month 1 questionnaire.	13.47 score on a scale STANDARD_DEVIATION 27.32 • n=99 Participants • The secondary outcome related to this baseline measure requires participants to have completed both baseline and Month 1 questionnaires to be included. Participants who did not complete both were excluded. Five control arm participants did not complete the Month 1 questionnaire. One control arm participant did not complete the baseline questionnaire. Three experimental arm participants did not complete the Month 1 questionnaire.

PRIMARY outcome

Timeframe: At 1 month post treatment

Population: Five control arm participants were excluded from analysis because they did not complete the Month 1 questionnaire. One control arm participant was excluded because they did not complete the baseline questionnaire. Two experimental arm participants were excluded from analysis because they did not complete the Month 1 questionnaire.

Outcome measures

Outcome measures
Measure	Experimental: Short Course Vaginal Cuff Brachytherapy n=52 Participants Participants undergo short course vaginal cuff brachytherapy for 2 fractions with 1 week apart.	Control: Standard of Care Vaginal Cuff Brachytherapy n=48 Participants Participants undergo standard of care vaginal cuff brachytherapy for 3-5 fractions over no more than 3 weeks.
Change in Quality of Life From Baseline to 1 Month	2.08 score on a scale Standard Deviation 15.02	2.08 score on a scale Standard Deviation 18.23

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one month post-treatment

Population: Five control arm participants were excluded from analysis because they did not complete the Month 1 questionnaire. One control arm participants was excluded because they did not complete the baseline questionnaire. Three experimental arm participants were excluded from analysis because they did not complete the Month 1 questionnaire.

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.

Outcome measures

Outcome measures
Measure	Experimental: Short Course Vaginal Cuff Brachytherapy n=51 Participants Participants undergo short course vaginal cuff brachytherapy for 2 fractions with 1 week apart.	Control: Standard of Care Vaginal Cuff Brachytherapy n=48 Participants Participants undergo standard of care vaginal cuff brachytherapy for 3-5 fractions over no more than 3 weeks.
Treatment-related Symptoms on HRQOL Using European Organization for Research and Treatment of Cancer Endometrial Cancer Module (EORTC EN24), Question 48	0.65 score on a scale Standard Deviation 22.6	-6.25 score on a scale Standard Deviation 29.7

SECONDARY outcome

Timeframe: Approximately 6 months after treatment

Population: Amount charged for procedures could not be obtained for six participants on the experimental arm.

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.

Outcome measures

Outcome measures
Measure	Experimental: Short Course Vaginal Cuff Brachytherapy n=48 Participants Participants undergo short course vaginal cuff brachytherapy for 2 fractions with 1 week apart.	Control: Standard of Care Vaginal Cuff Brachytherapy n=54 Participants Participants undergo standard of care vaginal cuff brachytherapy for 3-5 fractions over no more than 3 weeks.
USD Amount Charged for Procedures	33204.97 US Dollars (USD) Standard Deviation 16867.76	45919.55 US Dollars (USD) Standard Deviation 19808.48

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Experimental: Short Course Vaginal Cuff Brachytherapy

Serious events: 2 serious events

Other events: 46 other events

Deaths: 2 deaths

Control: Standard of Care Vaginal Cuff Brachytherapy

Serious events: 2 serious events

Other events: 50 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Experimental: Short Course Vaginal Cuff Brachytherapy n=54 participants at risk Participants undergo short course vaginal cuff brachytherapy for 2 fractions with 1 week apart.	Control: Standard of Care Vaginal Cuff Brachytherapy n=54 participants at risk Participants undergo standard of care vaginal cuff brachytherapy for 3-5 fractions over no more than 3 weeks.
Cardiac disorders Cardiac disorders - Other, specify	0.00% 0/54 • 12 months after start of brachytherapy Routine safety and tolerability were evaluated at each study visit from the results of reported signs and symptoms, scheduled physical examinations, vital sign measurements, and clinical laboratory test results. Information about all adverse events, whether volunteered by the participant, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected, recorded and followed as appropriate.	1.9% 1/54 • Number of events 1 • 12 months after start of brachytherapy Routine safety and tolerability were evaluated at each study visit from the results of reported signs and symptoms, scheduled physical examinations, vital sign measurements, and clinical laboratory test results. Information about all adverse events, whether volunteered by the participant, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected, recorded and followed as appropriate.
Vascular disorders Hypotension	0.00% 0/54 • 12 months after start of brachytherapy Routine safety and tolerability were evaluated at each study visit from the results of reported signs and symptoms, scheduled physical examinations, vital sign measurements, and clinical laboratory test results. Information about all adverse events, whether volunteered by the participant, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected, recorded and followed as appropriate.	1.9% 1/54 • Number of events 1 • 12 months after start of brachytherapy Routine safety and tolerability were evaluated at each study visit from the results of reported signs and symptoms, scheduled physical examinations, vital sign measurements, and clinical laboratory test results. Information about all adverse events, whether volunteered by the participant, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected, recorded and followed as appropriate.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/54 • 12 months after start of brachytherapy Routine safety and tolerability were evaluated at each study visit from the results of reported signs and symptoms, scheduled physical examinations, vital sign measurements, and clinical laboratory test results. Information about all adverse events, whether volunteered by the participant, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected, recorded and followed as appropriate.	1.9% 1/54 • Number of events 1 • 12 months after start of brachytherapy Routine safety and tolerability were evaluated at each study visit from the results of reported signs and symptoms, scheduled physical examinations, vital sign measurements, and clinical laboratory test results. Information about all adverse events, whether volunteered by the participant, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected, recorded and followed as appropriate.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	1.9% 1/54 • Number of events 1 • 12 months after start of brachytherapy Routine safety and tolerability were evaluated at each study visit from the results of reported signs and symptoms, scheduled physical examinations, vital sign measurements, and clinical laboratory test results. Information about all adverse events, whether volunteered by the participant, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected, recorded and followed as appropriate.	0.00% 0/54 • 12 months after start of brachytherapy Routine safety and tolerability were evaluated at each study visit from the results of reported signs and symptoms, scheduled physical examinations, vital sign measurements, and clinical laboratory test results. Information about all adverse events, whether volunteered by the participant, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected, recorded and followed as appropriate.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/54 • 12 months after start of brachytherapy Routine safety and tolerability were evaluated at each study visit from the results of reported signs and symptoms, scheduled physical examinations, vital sign measurements, and clinical laboratory test results. Information about all adverse events, whether volunteered by the participant, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected, recorded and followed as appropriate.	1.9% 1/54 • Number of events 1 • 12 months after start of brachytherapy Routine safety and tolerability were evaluated at each study visit from the results of reported signs and symptoms, scheduled physical examinations, vital sign measurements, and clinical laboratory test results. Information about all adverse events, whether volunteered by the participant, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected, recorded and followed as appropriate.
Infections and infestations Sepsis	1.9% 1/54 • Number of events 1 • 12 months after start of brachytherapy Routine safety and tolerability were evaluated at each study visit from the results of reported signs and symptoms, scheduled physical examinations, vital sign measurements, and clinical laboratory test results. Information about all adverse events, whether volunteered by the participant, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected, recorded and followed as appropriate.	0.00% 0/54 • 12 months after start of brachytherapy Routine safety and tolerability were evaluated at each study visit from the results of reported signs and symptoms, scheduled physical examinations, vital sign measurements, and clinical laboratory test results. Information about all adverse events, whether volunteered by the participant, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected, recorded and followed as appropriate.
Infections and infestations Skin infection	1.9% 1/54 • Number of events 1 • 12 months after start of brachytherapy Routine safety and tolerability were evaluated at each study visit from the results of reported signs and symptoms, scheduled physical examinations, vital sign measurements, and clinical laboratory test results. Information about all adverse events, whether volunteered by the participant, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected, recorded and followed as appropriate.	0.00% 0/54 • 12 months after start of brachytherapy Routine safety and tolerability were evaluated at each study visit from the results of reported signs and symptoms, scheduled physical examinations, vital sign measurements, and clinical laboratory test results. Information about all adverse events, whether volunteered by the participant, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected, recorded and followed as appropriate.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/54 • 12 months after start of brachytherapy Routine safety and tolerability were evaluated at each study visit from the results of reported signs and symptoms, scheduled physical examinations, vital sign measurements, and clinical laboratory test results. Information about all adverse events, whether volunteered by the participant, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected, recorded and followed as appropriate.	1.9% 1/54 • Number of events 2 • 12 months after start of brachytherapy Routine safety and tolerability were evaluated at each study visit from the results of reported signs and symptoms, scheduled physical examinations, vital sign measurements, and clinical laboratory test results. Information about all adverse events, whether volunteered by the participant, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected, recorded and followed as appropriate.

Other adverse events

Additional Information

IIT Data Management Team

Research Compliance Office, Huntsman Cancer Institute

Phone: 801-213-6215

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place