Short Course Brachytherapy for Stage I-II Endometrial Cancer
Short Course Vaginal Cuff Brachytherapy in Treating Participants With Stage I-II Endometrial Cancer
Recruiting
Phase 3Interventional Study
Endometrial Clear Cell AdenocarcinomaEndometrial Endometrioid AdenocarcinomaEndometrial Serous AdenocarcinomaStage I Uterine Corpus CancerStage IA Uterine Corpus CancerStage IB Uterine Corpus CancerStage II Uterine Corpus CancerUterine Corpus CarcinosarcomaUterine Corpus Sarcoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
188 (estimated)
Sponsor
University of Utah · Other
Who this trial is looking for
This trial is looking for women with certain types of early-stage endometrial cancer. Participants will receive a type of internal radiation therapy aimed at killing tumor cells. This treatment will be compared to the standard approach to see which is more effective.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with endometrial carcinoma.
I am post-hysterectomy and free from any remaining disease.
I have a performance status of 0-2.
I can provide informed consent.
I expect to live more than 2 years.
You may not be able to join if
I have a different stage of endometrial carcinoma.
I have had pelvic radiotherapy before.
I have another cancer that requires treatment other than surgery.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 participants 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…
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 participants 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.
After completion of cohort 1 (108 participants), the protocol was expended to add a second cohort of 80 additional participants, and re-opened study recruitment.
Trial Locations
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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 permitte…
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 1 with LVSI, 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.
* Concurrent malignancy requiring non-protocol anti-cancer treatment other than surgery.
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