Last updated on June 2019

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


Brief description of study

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 Study 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.

Clinical Study Identifier: NCT03422198

Find a site near you

Start Over

Intermountain Healthcare / LDS Hospital

Salt Lake City, UT United States
5.87miles
  Connect »

Huntsman Cancer Institute/University of Utah

Salt Lake City, UT United States
7.79miles
  Connect »