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Cesium-131 Brachytherapy for Recurrent Gynecologic Cancer

This study is looking at a treatment called Cesium-131 Low Dose Radiation (LDR) brachytherapy for women with gynecologic cancer (cervical or endometrial cancer) that has returned in the vagina after previous radiation treatment. This type of cancer often requires a major surgery to remove many pelvic organs. This study aims to see if Cesium-131 LDR brachytherapy can help preserve these organs. The treatment involves placing a device one time by a radiation oncologist. The main goal is to see how many participants are able to keep their organs after one year. The study is currently unclear on its status and plans to enroll 10 women who are at least 18 years old and meet specific criteria for their cancer type and history of radiation.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is planned to include 10 participants.
What's involved
Participants will have a Cesium-131 LDR device placed one time by a radiation oncologist under sedation.
Compensation
Not stated in the trial record.
Follow-up
The main goal of the study is measured at 1 year to see if organs are preserved.

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NCT07631572

Cs-131LDR Brachytherapy for Organ-Preserving Irradiation for Recurrent Cervical and Endometrial Cancer

Recruiting
NAAges 18+InterventionalTreatment
Denise Fabian
~10 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:Cesium-131 Low Dose Radiation (LDR)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants with organ preservation
Measured over 1 Year

Conditions

Gynecologic Cancer

Explore related trials

Cervical CarcinomaEndometrial Carcinoma

Where it's being run

1 sites across 1 states
Kentucky1

Who to contact

Heather Pavlik
[email protected]
8593232354
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Proportion of participants with organ preservation1 Year

    Organ preservation rate is defined as avoidance of pelvic exenteration and organ sacrificing surgeries including total vaginectomy, cystectomy and anterior perineal resection.