Study on Short Course Vaginal Cuff Brachytherapy for Treating Stage I-II Endometrial Cancer

Sponsor: University of Utah

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03422198

Provider View

This clinical trial is comparing a shorter course of internal radiation therapy, called vaginal cuff brachytherapy, to the standard treatment for patients with stage I-II endometrial cancer. The study aims to see if the shorter treatment is as effective and has similar side effects.

Patient Parameters

Program Overview

This study is testing a shorter version of vaginal cuff brachytherapy, a type of internal radiation therapy, to see if it works as well as the standard treatment for patients with stage I-II endometrial cancer. The therapy involves placing radioactive material near the tumor in the upper part of the vagina to kill cancer cells. The trial initially included 108 participants and has been expanded to include 80 more, reopening recruitment.

Description

Primary Objectives:

  • To assess if the shorter treatment affects patients' quality of life similarly to the standard treatment, using a health questionnaire one month after treatment.

Secondary Objectives:

  • To compare symptoms related to treatment between the two groups using a specific cancer questionnaire.
  • To evaluate the cost-effectiveness of the two treatments.

Tertiary Objectives:

  • To report symptoms affecting the vagina, bowel, and bladder using a cancer questionnaire.
  • To compare side effects between the two treatments.
  • To track and compare cancer recurrence patterns between the two groups, with evaluations during and at the end of the study.
  • To compare radiation doses to nearby organs like the bladder and rectum.
  • To compare the total travel distance to the cancer center for study visits.

Study Design:

Participants are randomly assigned to one of two groups:

  • Group I: Receives short course vaginal cuff brachytherapy in 2 sessions, one week apart.
  • Group II: Receives standard vaginal cuff brachytherapy in 3-5 sessions over up to 3 weeks.

After treatment, participants will have follow-up visits at 1, 6, and 12 months.

Cohort 2 (Pilot Expansion):

Primary Objective:

  • To evaluate the financial impact reported by participants one month after receiving the short course treatment.

Exploratory Objectives:

  • To explore differences in financial impact between the two groups.
  • To assess diet, physical activity, and quality of life in patients one month after treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with specific types of endometrial cancer, including endometrioid, serous, and clear cell types, primarily located in the uterus.
  • Cancer stages and grades include:
    • Stage IA, grade 2 or 3
    • Stage IB, grades 1-3
    • Stage II, grades 1-3
    • Stage IIIA, grades 1-3, not receiving additional radiation therapy.
  • Have had a hysterectomy and no remaining cancer.
  • Good overall health with a performance status score of 0-2.
  • Able to provide informed consent.
  • Life expectancy of more than 2 years.

Exclusion Criteria

  • Other stages of endometrial cancer not specified.
  • Previous radiation therapy to the pelvic area.
  • More than 16 weeks between hysterectomy and planned start of radiation therapy.

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