Short Course Vaginal Cuff Brachytherapy in Treating Participants With Stage I-II Endometrial Cancer — SAVE  

Endometrial Serous Adenocarcinoma Clinical Trial

Official title: Short Course Adjuvant Vaginal Cuff Brachytherapy (VCB) in Early Endometrial Cancer Compared to Standard of Care (SAVE)

Status Recruiting

Clinical Trial 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 participants 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.

After completion of cohort 1 (108 participants), the protocol was expended to add a second cohort of 80 additional participants, and re-opened study recruitment.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. Evaluate the non-inferiority of participant 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 participants 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: Participants are randomized to 1 of 2 arms.

Arm I: Participants undergo short course vaginal cuff brachytherapy for 2 fractions with 1 week apart.

Arm II: Participants undergo standard of care vaginal cuff brachytherapy for 3-5 fractions over no more than 3 weeks.

After completion of study treatment, participants are followed up at 1, 6, and 12 months.

COHORT 2 (PILOT EXPANSION)

PRIMARY OBJECTIVES:

I. The primary objective is to evaluate the frequency and severity of participant-reported financial toxicity in participants with early-stage endometrial cancer treated with vaginal cuff-brachytherapy (VCB) at one-month post-VCB.

SECONDARY OBJECTIVES:

I. Secondary objectives include evaluation of participant-reported diet and physical activity levels and quality of life in participants with early-stage endometrial cancer treated with vaginal cuff-brachytherapy (VCB) at one-month post-VCB.

EXPLORATORY OBJECTIVES:

I. Exploratory objectives will include evaluation of differences in participant-reported financial toxicity, dietary and physical activity habits between cohorts, to assess any impact of treatment duration on outcomes. ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma, Endometrioid
• Carcinosarcoma
• Endometrial Clear Cell Adenocarcinoma
• Endometrial Endometrioid Adenocarcinoma
• Endometrial Neoplasms
• 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

• NCT number: NCT03422198
• Study type: Interventional
• Source: University of Utah
• Contact: Cristina DeCesaris, MD
• Phone: 801-585-0255
• Email: Cristina.DeCesaris@hci.utah.edu
• Status: Recruiting
• Phase: Phase 3
• Start date: January 30, 2018
• Completion date: October 31, 2029