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

Status: Active

Description

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.

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 and stage II, 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

Locations & Contacts

Utah

Murray
Intermountain Medical Center
Status: Active
Contact: Jonathan D. Grant
Phone: 801-507-3888
Email: Jon.grant@imail.org
Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Active
Contact: David K. Gaffney
Phone: 801-585-0255
Email: david.gaffney@hci.utah.edu
Intermountain Health Care
Status: Active
Contact: Jonathan D. Grant
Phone: 801-507-3888
Email: Jon.grant@imail.org

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. Evaluate the non-inferiority of patient health related quality of life (HRQOL) using the Global Health Status 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.

EXPLORATORY 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.

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
Huntsman Cancer Institute / University of Utah

Principal Investigator
David K. Gaffney

Trial IDs

Primary ID HCI103841
Secondary IDs NCI-2018-00011
Clinicaltrials.gov ID NCT03422198