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

ConditionsEndometrial Clear Cell AdenocarcinomaEndometrial Endometrioid AdenocarcinomaEndometrial Serous AdenocarcinomaStage I Uterine Corpus CancerStage IA Uterine Corpus CancerStage IB Uterine Corpus CancerStage II Uterine Corpus CancerUterine Corpus CarcinosarcomaUterine Corpus Sarcoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Utah

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Stages of endometrial carcinoma other than described.

Previous pelvic radiotherapy.

Concurrent malignancy requiring non-protocol anti-cancer treatment other than surgery.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vaginal Cuff Brachytherapy

    Radiation

    Undergo standard of care vaginal cuff brachytherapy

  • Short course vaginal cuff brachytherapy

    Radiation

    Undergo short course vaginal cuff brachytherapy

Treatment groups

188 Participants
are divided into 2 treatment groups
Group A: Short course vaginal cuff brachytherapyExperimental treatment 1 intervention
Group B: Vaginal cuff brachytherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At 1 month post treatment
2

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.

Time frame
One month after brachytherapy

Secondary outcomes

1

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.

Time frame
one month post-treatment
2

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.

Time frame
Approximately 6 months after treatment
3

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.

Time frame
One month after brachytherapy
4

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.

Time frame
One month after brachytherapy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Utah

Lead sponsor

Huntsman Cancer Institute

Collaborator

Source ClinicalTrials.gov
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