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

Launched by UNIVERSITY OF UTAH · Feb 2, 2018

Keywords

ClinConnect Summary

This clinical trial is looking at a type of treatment called short course vaginal cuff brachytherapy for patients with early-stage endometrial cancer, which is cancer of the lining of the uterus. This treatment involves placing a small amount of radioactive material directly into or near the tumor area in the upper vagina to help kill cancer cells. The study aims to see how effective this shorter treatment is compared to the standard method that takes longer. Researchers are currently recruiting participants, with a goal of including those who have specific types of endometrial cancer and have already had a hysterectomy (removal of the uterus).

To be eligible for this trial, participants must have a confirmed diagnosis of certain types of endometrial cancer and meet specific criteria, such as having no remaining cancer after surgery. They should also be in good overall health and able to provide consent for the treatment. Participants can expect to receive this focused radiation therapy in a shorter time frame, which may offer benefits in terms of convenience and potentially fewer side effects. It's important for anyone interested to discuss this opportunity with their healthcare provider to see if they qualify and to understand more about what being part of the trial involves.

Gender

ALL

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, 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
• • Stage IIIA, grades 1-3, not receiving EBRT as part of adjuvant therapy.
• • Participants 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.
• • Life expectancy of \>2 years.
• Exclusion Criteria:
• • Stages of endometrial carcinoma other than described.
• • Previous pelvic radiotherapy.
• • Interval between the hysterectomy and planned start of radiotherapy exceeding 16 weeks.