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

Study Overview
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Brief Summary
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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 patients 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.

Detailed Description
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PRIMARY OBJECTIVES: I. Evaluate the non-inferiority of patient 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 patients 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: Patients are randomized to 1 of 2 arms. Arm I: Patients undergo short course vaginal cuff brachytherapy for 2 fractions with 1 week apart. Arm II: Patients undergo standard of care vaginal cuff brachytherapy for 3-5 fractions over no more than 3 weeks. After completion of study treatment, patients are followed up at 1, 6, and 12 months.

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

Conditions
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Endometrial Clear Cell Adenocarcinoma, Endometrial Endometrioid Adenocarcinoma, 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 / Treatment
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* Radiation: Vaginal Cuff Brachytherapy
* Radiation: Short course vaginal cuff brachytherapy


Participation Criteria
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Eligibility Criteria
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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 Patients 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Short course vaginal cuff brachytherapy<br>Patients undergo short course vaginal cuff brachytherapy for 2 fractions with 1 week apart. | Radiation: Short course vaginal cuff brachytherapy<br>* Undergo short course vaginal cuff brachytherapy<br>* Other names: Radiation Brachytherapy;|
| Active Comparator: Vaginal cuff brachytherapy<br>Patients undergo standard of care vaginal cuff brachytherapy for 3-5 fractions over no more than 3 weeks. | Radiation: Vaginal Cuff Brachytherapy<br>* Undergo standard of care vaginal cuff brachytherapy<br>* Other names: standard therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |