A Phase 3 interventional study of Vaginal Cuff Brachytherapy and Short course vaginal cuff brachytherapy in Endometrial Clear Cell Adenocarcinoma, Endometrial Endometrioid Adenocarcinoma and Endometrial Serous Adenocarcinoma, sponsored by University of Utah. Recruiting at 5 sites in United States. Per ClinicalTrials.gov, last updated 2025-12-12.
Sponsored by University of Utah · Phase 3, Interventional, and Treatment
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.
Endometrial cancer is the most common gynecologic cancer in the Western world and primarily affects postmenopausal women. The primary form of treatment is surgery, consisting of a total abdominal or laparoscopic hysterectomy and bilateral salpingo-oophorectomy. Adjuvant radiotherapy for endometrial cancer has been studied in prospective trials for at least four decades. All trials have demonstrated an improvement in local regional control. However, improvement in survival has not been observed in prospective randomized trials in early-stage patients.
There is great heterogeneity in prognoses in stage I patients. National Comprehensive Cancer Network (NCCN) guidelines consequently recommend no treatment in general for low-stage patients, adjuvant brachytherapy for patients with intermediate- and high-intermediate-risk disease, and for patients with deeply invasive tumors with high-grade lesions, external beam radiotherapy is an option (NCCN Guidelines 2016). Over the ensuing decades, there has been a shift toward increasing use of vaginal cuff brachytherapy.
This is a phase III, unblinded, randomized trial comparing an experimental arm and a control arm of vaginal cuff brachytherapy: The experimental arm will treat subjects with 2 fractions of vaginal brachytherapy. The control arm will treat subjects with standard-of-care vaginal cuff brachytherapy of 3-5 fractions. Patients will be randomized 1:1 to the different treatment arms.
After completion of cohort 1 (108 participants), the protocol was expanded to add a second cohort of 80 additional participants, and reopened study recruitment.
Cohort 1 evaluated the non-inferiority of patient Health Related Quality of Life (HRQOL) in the experimental arm compared to the control arm using the Global Health Status from the EORTC QLQ-C30. Cohort 2 will evaluate the frequency and severity of patient-reported financial toxicity in patients with early-stage endometrial cancer treated with vaginal cuff-brachytherapy (VCB) at one month post-VCB.
46 studies on the registry are indexed under Adenocarcinoma, Clear Cell; 8 are open to participants now.
This study's planned enrollment of 188 is above the median of 47 across 42 interventional studies indexed under Adenocarcinoma, Clear Cell.
Browse Adenocarcinoma, Clear Cell studies →University of Utah is the lead sponsor of 994 studies on the registry; 175 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 69 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants undergo short course vaginal cuff brachytherapy for 2 fractions with 1 week apart.
Radiation: Short course vaginal cuff brachytherapy
Participants undergo standard of care vaginal cuff brachytherapy for 3-5 fractions over no more than 3 weeks.
Radiation: Vaginal Cuff Brachytherapy
Undergo standard of care vaginal cuff brachytherapy
Also known as: best practice, standard of care, standard therapy
Undergo short course vaginal cuff brachytherapy
Also known as: BRACHYTHERAPY, internal radiation, Internal Radiation Brachytherapy, Internal Radiation Therapy, Radiation Brachytherapy
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
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
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
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
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
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
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.
Time frame: One month after brachytherapy
| Milestone | Experimental: Short Course Vaginal Cuff Brachytherapy | Control: Standard of Care Vaginal Cuff Brachytherapy |
|---|---|---|
| Started | 54 | 54 |
| Completed | 54 | 54 |
| Not completed | 0 | 0 |
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.
| score on a scale | Experimental: Short Course Vaginal Cuff Brachytherapy | Control: Standard of Care Vaginal Cuff Brachytherapy |
|---|---|---|
| Change in Quality of Life From Baseline to 1 Month | 2.08 ± 15.02 | 2.08 ± 18.23 |
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.
Results for this outcome have not been posted.
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.
| score on a scale | Experimental: Short Course Vaginal Cuff Brachytherapy | Control: Standard of Care Vaginal Cuff Brachytherapy |
|---|---|---|
| Treatment-related Symptoms on HRQOL Using European Organization for Research and Treatment of Cancer Endometrial Cancer Module (EORTC EN24), Question 48 | 0.65 ± 22.6 | -6.25 ± 29.7 |
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.
| US Dollars (USD) | Experimental: Short Course Vaginal Cuff Brachytherapy | Control: Standard of Care Vaginal Cuff Brachytherapy |
|---|---|---|
| USD Amount Charged for Procedures | 33204.97 ± 16867.76 | 45919.55 ± 19808.48 |
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Collected over 12 months after start of brachytherapy. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental: Short Course Vaginal Cuff Brachytherapy | 2/54 (3.7%) | 2/54 (3.7%) | 46/54 (85.2%) |
| Control: Standard of Care Vaginal Cuff Brachytherapy | 1/54 (1.9%) | 2/54 (3.7%) | 50/54 (92.6%) |
| Event | Experimental: Short Course Vaginal Cuff Brachytherapy | Control: Standard of Care Vaginal Cuff Brachytherapy |
|---|---|---|
| Cardiac disorders - Other, specifyCardiac disorders | 0/54 | 1/54 |
| HypotensionVascular disorders | 0/54 | 1/54 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 0/54 | 1/54 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specifyNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/54 | 0/54 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 0/54 | 1/54 |
| SepsisInfections and infestations | 1/54 | 0/54 |
| Skin infectionInfections and infestations | 1/54 | 0/54 |
| Wound dehiscenceInjury, poisoning and procedural complications | 0/54 | 1/54 |
| Event | Experimental: Short Course Vaginal Cuff Brachytherapy | Control: Standard of Care Vaginal Cuff Brachytherapy |
|---|---|---|
| FatigueGeneral disorders | 20/54 | 23/54 |
| DiarrheaGastrointestinal disorders | 12/54 | 16/54 |
| Urinary incontinenceRenal and urinary disorders | 4/54 | 10/54 |
| Abdominal painGastrointestinal disorders | 5/54 | 9/54 |
| ConstipationGastrointestinal disorders | 4/54 | 9/54 |
| NauseaGastrointestinal disorders | 7/54 | 9/54 |
| Peripheral sensory neuropathyNervous system disorders | 4/54 | 9/54 |
| Pelvic painReproductive system and breast disorders | 4/54 | 8/54 |
| Vaginal hemorrhageReproductive system and breast disorders | 4/54 | 8/54 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 2/54 | 5/54 |
| Age, Categorical(Participants) | Experimental: Short Course Vaginal Cuff Brachytherapy | Control: Standard of Care Vaginal Cuff Brachytherapy | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 22 | 31 | 53 |
| >=65 years | 32 | 23 | 55 |
| Age, Continuous(years) | Experimental: Short Course Vaginal Cuff Brachytherapy | Control: Standard of Care Vaginal Cuff Brachytherapy | Total |
|---|---|---|---|
| Mean | 65.31 ± 10.25 | 63.65 ± 9.68 | 64.48 ± 9.95 |
| Age, Continuous(years) | Experimental: Short Course Vaginal Cuff Brachytherapy | Control: Standard of Care Vaginal Cuff Brachytherapy | Total |
|---|---|---|---|
| Median | 66.5 (40 to 84) | 63.5 (30 to 87) | 65 (30 to 87) |
| Sex: Female, Male(Participants) | Experimental: Short Course Vaginal Cuff Brachytherapy | Control: Standard of Care Vaginal Cuff Brachytherapy | Total |
|---|---|---|---|
| Female | 54 | 54 | 108 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Experimental: Short Course Vaginal Cuff Brachytherapy | Control: Standard of Care Vaginal Cuff Brachytherapy | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 6 | 11 |
| Not Hispanic or Latino | 46 | 48 | 94 |
| Unknown or Not Reported | 3 | 0 | 3 |
| Race (NIH/OMB)(Participants) | Experimental: Short Course Vaginal Cuff Brachytherapy | Control: Standard of Care Vaginal Cuff Brachytherapy | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 5 | 10 |
| White | 41 | 45 | 86 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 7 | 2 | 9 |
| Baseline EORTC Quality of Life Score(score on a scale) | Experimental: Short Course Vaginal Cuff Brachytherapy | Control: Standard of Care Vaginal Cuff Brachytherapy | Total |
|---|---|---|---|
| Mean | 72.28 ± 21.5 | 67.88 ± 21.74 | 70.17 ± 21.26 |
| Baseline EORTC Symptom Score(score on a scale) | Experimental: Short Course Vaginal Cuff Brachytherapy | Control: Standard of Care Vaginal Cuff Brachytherapy | Total |
|---|---|---|---|
| Mean | 10.46 ± 26.24 | 16.67 ± 28.35 | 13.47 ± 27.32 |
Not enrolling at this site.
Not enrolling at this site.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.