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

Status:	Recruiting
Healthy:	No
Age Range:	Any
Updated:	11/23/2018
Start Date:	January 17, 2018
End Date:	January 8, 2022
Contact:	Marissa Muse
Email:	marissa.muse@hci.utah.edu
Phone:	801-587-9834

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

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.

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.

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

Exclusion Criteria:

- Stages of endometrial carcinoma other than described

- Previous malignancy (except for non-melanomatous skin cancer) < 5 years

- Previous pelvic radiotherapy

- Interval between the hysterectomy and planned start of radiotherapy exceeding 16 weeks

We found this trial at

sites

Intermountain Healthcare, LDS Hospital

Salt Lake City, Utah 84143

Principal Investigator: Jonathan D Grant, MD

Phone: 801-507-3950

from

Salt Lake City, UT