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

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ClinicalTrials.gov Identifier: NCT03422198
Recruitment Status : Recruiting
First Posted : February 5, 2018
Last Update Posted : January 15, 2021
Sponsor:
Information provided by (Responsible Party):
University of Utah

Tracking Information
First Submitted Date  ICMJE January 16, 2018
First Posted Date  ICMJE February 5, 2018
Last Update Posted Date January 15, 2021
Actual Study Start Date  ICMJE January 17, 2018
Estimated Primary Completion Date January 8, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2018)
Health related quality of life (HRQOL) using the Global Health Score from the Quality of Life Questionnaire Core 30 (QLQ-C30) [ Time Frame: At 1 month post treatment ]
Scores determined from patient completed questionnaires will be compared between the two treatment arms one month after treatment completion. The primary analysis will be analysis of covariance with Global Health Score at one month post therapy as Gaussian response variable, treatment group as a fixed effect and baseline Global Health Score as a continuous adjustment variable. The primary hypothesis is that the Global Health Score is non-inferior in the Experimental Arm compared to the Control Arm. Differences of 10 points or more in the global scales are widely viewed as being clinically significant when evaluating the results of randomized clinical trials and thus we will use a 10 point equivalence margin. The primary analysis will be analysis of covariance with Global Health Score at one month post therapy as Gaussian response variable, treatment group as a fixed effect and baseline Global Health Score as a continuous adjustment variable.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2018)
  • Treatment-related symptoms on HRQOL using European Organization for Research and Treatment of Cancer Endometrial Cancer Module (EORTC EN24), question 48 [ Time Frame: Up to 12 months ]
    Scores determined from patient completed question, Have you felt less feminine due to your disease or treatment? will be compared between the two treatment arms. Ordinal logistic regression will be used to analyze this question, with one month value as outcome variable, treatment arm as primary predictor, and the baseline value as covariate. A non-inferiority analysis will be performed with equivalence margin equal to 6.1 points, which represents approximately 1/2 standard deviation. Additional exploratory logistic regression analyses will include the values at all time points (baseline, one
  • Cost effectiveness (CE) [ Time Frame: Up to 6 months ]
    Cost of procedures will be compared between the two treatment arms
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Short Course Vaginal Cuff Brachytherapy in Treating Patients With Stage I-II Endometrial Cancer
Official Title  ICMJE Short Course Adjuvant Vaginal Cuff Brachytherapy (VCB) in Early Endometrial Cancer Compared to Standard of Care (SAVE)
Brief 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 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

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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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  ICMJE
  • Radiation: Vaginal Cuff Brachytherapy
    Undergo standard of care vaginal cuff brachytherapy
    Other Names:
    • best practice
    • standard of care
    • standard therapy
  • Radiation: Short course vaginal cuff brachytherapy
    Undergo short course vaginal cuff brachytherapy
    Other Names:
    • BRACHYTHERAPY
    • internal radiation
    • Internal Radiation Brachytherapy
    • Internal Radiation Therapy
    • Radiation Brachytherapy
Study Arms  ICMJE
  • Experimental: Short course vaginal cuff brachytherapy
    Patients undergo short course vaginal cuff brachytherapy for 2 fractions with 1 week apart.
    Intervention: Radiation: Short course vaginal cuff brachytherapy
  • Active Comparator: Vaginal cuff brachytherapy
    Patients undergo standard of care vaginal cuff brachytherapy for 3-5 fractions over no more than 3 weeks.
    Intervention: Radiation: Vaginal Cuff Brachytherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 2, 2018)
108
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 8, 2022
Estimated Primary Completion Date January 8, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marissa Muse 801-587-9834 marissa.muse@hci.utah.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03422198
Other Study ID Numbers  ICMJE HCI103841
NCI-2018-00011 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Utah
Study Sponsor  ICMJE University of Utah
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Gaffney Huntsman Cancer Institute/ University of Utah
PRS Account University of Utah
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP