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
Last Update Posted : June 21, 2022
|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|
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.
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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
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
- 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.
- 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
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
|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|
|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|
|Principal Investigator:||David Gaffney, MD||Huntsman Cancer Institute/ University of Utah|