Cesium-131 brachytherapy to preserve organs in recurrent cervical or endometrial cancer
Official title: Phase II Clinical Trial of Cesium-131 Low-dose Rate Interstitial Brachytherapy as an Organ-preserving Irradiation Technique for Recurrent Cervical and Endometrial Cancer
Run by University of Kentucky · NCT07631572 · Data updated 2026-11-12
This study tests whether implanting small cesium-131 seeds can provide targeted radiation to vaginal recurrences of cervical or endometrial cancer in patients who previously had pelvic radiation, with the goal of preserving organs.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 10 (estimated) |
| Sponsor | University of Kentucky Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Lexington, Kentucky) |
| Status | Recruiting |
| Started | October 2026 |
| Main results expected | May 2029 |
| Study ends | May 2030 |
| Registry record updated | August 31, 2026 |
| Trial ID | NCT07631572 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with histologically confirmed vaginal recurrence of cervical or endometrial cancer after prior pelvic radiation, with a measurable lesion amenable to cesium-131 implant.
✕Probably not a fit
Patients with non-measurable lesions, extensive disease, or prior radiation limits that preclude implantation may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study explores the use of cesium-131 low-dose-rate interstitial brachytherapy as an organ-preserving radiation option for vaginal recurrences of gynecologic cancers after prior pelvic radiation. Eligible patients have measurable vaginal tumors and a history of pelvic radiation, and the treatment involves implanting radioactive seeds directly into the tumor. The aim is to deliver focused radiation while minimizing damage to surrounding tissues, offering an alternative to extensive surgery. The study is conducted at the University of Kentucky Markey Cancer Center under a lead sponsor and collaborators specified as Denise Fabian and staff. Outcomes will inform feasibility, safety, and potential effectiveness of this salvage approach.
Why it matters
Potential benefit: If successful, patients could receive effective local control with less extensive surgery and preservation of surrounding organs.
How similar studies have gone: Other brachytherapy approaches have shown local control in gynecologic recurrences, but this specific cesium-131 LDR implant approach is relatively novel for vaginal recurrences after pelvic radiation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients must have histologically or cytologically confirmed vaginal recurrence of endometrial (endometrioid adenocarcinoma, uterine serous, carcinosarcoma, clear cell) or cervical (squamous, adenosquamous, or adenocarcinoma) cancer and prior history of pelvic radiation. * Patients must have vaginal recurrence that is amenable to cesium implant for salvage * Patients must have a vaginal lesion that is measurable according to RECIST 1.1 criteria; that is, at least 1 cm upon measurement by CT, or MRI if the patient cannot have a CT with contrast or lesion is not visualized on CT scan, or measurement by calipers if the lesion is not seen on CT or MRI. * Patients must have previous external beam radiation treatment to the pelvis for the uterine cervix or endometrial malignancy that has recurred to be eligible for this study, so long as the prior exposure does not exceed tolerance at the discretion of the treating physician. * Gynecologic Oncology Group performance status of 0, 1, or 2 (see Appendix A). * There are no minimum organ/marrow function requirements because patients will not be receiving systemic therapy. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Patients who have another concurrent, active invasive malignancy or have had a prior invasive malignancy diagnosed within the last three years, with the following two exceptions: \[a\] non-melanoma skin cancer and/or \[b\] prior in situ carcinoma of the cervix and/or \[c\] in situ bladder cancer. * Patients who have metastatic or regional lymph node metastases who have radiographic evidence of disease at time of study enrollment. Patients who have had metastasis or lymph nodes previously treated without radiographic disease at time of study enrollment may be considered at discretion of the treating radiation oncologist. * Receipt of epoetin alpha (Procrit, Epogen) within 1 month of study screening. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to Cesium-131 implant or other agents used in this study. * Pregnant women are excluded from this study because radiation is a known teratogen. Patient must agree to use two forms of birth control if they are of child-bearing potential. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, throughout duration of active treatment and for two months after completion of radiation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.
Where it's running
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University of Kentucky Markey Cancer Center
Lexington, Kentucky, United States Recruiting
Study contacts
- Study coordinator: Heather Pavlik
- Email: heather.schroer@uky.edu
- Phone: 8593232354
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.