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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 : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
University of Utah

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.

Condition or disease Intervention/treatment Phase
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 Radiation: Vaginal Cuff Brachytherapy Radiation: Short course vaginal cuff brachytherapy Phase 3

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.

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Short Course Adjuvant Vaginal Cuff Brachytherapy (VCB) in Early Endometrial Cancer Compared to Standard of Care (SAVE)
Actual Study Start Date : January 17, 2018
Estimated Primary Completion Date : January 8, 2022
Estimated Study Completion Date : January 8, 2022


Arm Intervention/treatment
Experimental: Short course vaginal cuff brachytherapy
Patients undergo short course vaginal cuff brachytherapy for 2 fractions with 1 week apart.
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

Active Comparator: Vaginal cuff brachytherapy
Patients 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
Other Names:
  • best practice
  • standard of care
  • standard therapy




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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

  2. Cost effectiveness (CE) [ Time Frame: Up to 6 months ]
    Cost of procedures will be compared between the two treatment arms



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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, with PI confirmation. Carcinosarcoma and other sarcomas are permitted; Federation of Gynecology and Obstetrics (FIGO) 2009 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

Exclusion Criteria:

  • Stages of endometrial carcinoma other than described
  • Previous malignancy (except for non-melanomatous skin cancer) < 5 years
  • Previous pelvic radiotherapy
  • Interval between the hysterectomy and planned start of radiotherapy exceeding 16 weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03422198


Contacts
Contact: Brady Gamble 801-585-0550 brady.gamble@hci.utah.edu

Locations
United States, Utah
Huntsman Cancer Institute/University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Brady Gamble    801-585-0550    brady.gamble@hci.utah.edu   
Principal Investigator: David K. Gaffney         
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: David Gaffney Huntsman Cancer Institute/ University of Utah

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT03422198     History of Changes
Other Study ID Numbers: HCI103841
NCI-2018-00011 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Sarcoma
Adenocarcinoma
Endometrial Neoplasms
Uterine Neoplasms
Carcinoma, Endometrioid
Cystadenocarcinoma, Serous
Carcinosarcoma
Mixed Tumor, Mullerian
Adenocarcinoma, Clear Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Ovarian Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Cystadenocarcinoma
Neoplasms, Cystic, Mucinous, and Serous
Neoplasms, Complex and Mixed
Neoplasms, Connective and Soft Tissue