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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03422198
Recruitment Status : Active, not recruiting
First Posted : February 5, 2018
Results First Posted : December 23, 2022
Last Update Posted : December 29, 2022
Sponsor:
Information provided by (Responsible Party):
University of Utah

Study Description
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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. 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual 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 30, 2018
Actual Primary Completion Date : December 2, 2021
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change in Quality of Life From Baseline to 1 Month [ Time Frame: At 1 month post treatment ]
    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.


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: one month post-treatment ]
    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.

  2. USD Amount Charged for Procedures [ Time Frame: Approximately 6 months after treatment ]
    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.


Eligibility Criteria
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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. 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
Contacts and Locations
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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


Locations
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United States, California
Stanford Cancer Center
Palo Alto, California, United States, 94304
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Texas
MD Anderson
Houston, Texas, United States, 77030
United States, Utah
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Intermountain Medical Center / LDS Hospital
Salt Lake City, Utah, United States, 84143
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: David Gaffney, MD Huntsman Cancer Institute/ University of Utah
  Study Documents (Full-Text)

Documents provided by University of Utah:
Study Protocol and Statistical Analysis Plan  [PDF] July 7, 2021

More Information
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Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT03422198    
Other Study ID Numbers: HCI103841
NCI-2018-00011 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: February 5, 2018    Key Record Dates
Results First Posted: December 23, 2022
Last Update Posted: December 29, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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