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

Primary Purpose

Endometrial Clear Cell Adenocarcinoma, Endometrial Endometrioid Adenocarcinoma, Endometrial Serous Adenocarcinoma

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Vaginal Cuff Brachytherapy
Short course vaginal cuff brachytherapy
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Clear Cell Adenocarcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford Cancer Center
  • Loyola University Medical Center
  • MD Anderson
  • Huntsman Cancer Institute/University of Utah
  • Intermountain Medical Center / LDS Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Short course vaginal cuff brachytherapy

Vaginal cuff brachytherapy

Arm Description

Patients undergo short course vaginal cuff brachytherapy for 2 fractions with 1 week apart.

Patients undergo standard of care vaginal cuff brachytherapy for 3-5 fractions over no more than 3 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 16, 2018
Last Updated
December 27, 2022
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT03422198
Brief Title
Short Course Vaginal Cuff Brachytherapy in Treating Patients With Stage I-II Endometrial Cancer
Acronym
SAVE
Official Title
Short Course Adjuvant Vaginal Cuff Brachytherapy (VCB) in Early Endometrial Cancer Compared to Standard of Care (SAVE)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 30, 2018 (Actual)
Primary Completion Date
December 2, 2021 (Actual)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Utah

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Short course vaginal cuff brachytherapy
Arm Type
Experimental
Arm Description
Patients undergo short course vaginal cuff brachytherapy for 2 fractions with 1 week apart.
Arm Title
Vaginal cuff brachytherapy
Arm Type
Active Comparator
Arm Description
Patients undergo standard of care vaginal cuff brachytherapy for 3-5 fractions over no more than 3 weeks.
Intervention Type
Radiation
Intervention Name(s)
Vaginal Cuff Brachytherapy
Other Intervention Name(s)
best practice, standard of care, standard therapy
Intervention Description
Undergo standard of care vaginal cuff brachytherapy
Intervention Type
Radiation
Intervention Name(s)
Short course vaginal cuff brachytherapy
Other Intervention Name(s)
BRACHYTHERAPY, internal radiation, Internal Radiation Brachytherapy, Internal Radiation Therapy, Radiation Brachytherapy
Intervention Description
Undergo short course vaginal cuff brachytherapy
Primary Outcome Measure Information:
Title
Change in Quality of Life From Baseline to 1 Month
Description
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
Secondary Outcome Measure Information:
Title
Treatment-related Symptoms on HRQOL Using European Organization for Research and Treatment of Cancer Endometrial Cancer Module (EORTC EN24), Question 48
Description
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
Title
USD Amount Charged for Procedures
Description
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Gaffney, MD
Organizational Affiliation
Huntsman Cancer Institute/ University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Cancer Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
MD Anderson
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Huntsman Cancer Institute/University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Intermountain Medical Center / LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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