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

NCT07631572 | Not Yet Recruiting FDA Device

• 1 other identifier: MCC-25-GYN-12
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

This clinical trial studies how well cesium-131 low-dose rate interstitial brachytherapy works as an organ-preserving radiation technique in the treatment of patients with cervical and endometrial cancer that has come back in the vagina after a period of improvement following pelvic radiation therapy (vaginal recurrence). In cervical and endometrial cancer patients with vaginal recurrence following pelvic radiation therapy, the only curative option involves a major surgical procedure which removes all the contents of the pelvic cavity, such as the uterus, cervix, bladder, rectum, vagina, and vulva. This procedure is complex and comes with many side effects; therefore, a need remains to improve radiation treatment techniques so radiation therapy can be offered as an alternative treatment option for these patients. Cesium-131 low-dose rate interstitial brachytherapy is a form of internal radiation therapy called brachytherapy. It uses grain-of-rice-sized radioactive seeds implanted directly into or near where the tumor has returned. The implanted seeds give off radiation to kill tumor cells for only a short time after they are placed. Most of the radiation is gone within a few weeks. The seeds stay in the body permanently, but they become inactive quickly. Cesium-131 low-dose rate interstitial brachytherapy may be an effective organ-preserving radiation technique for the treatment of cervical and endometrial cancer patients with vaginal recurrence following pelvic radiation therapy

Conditions

Gynecologic Cancer

Keywords

Cesium

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with organ preservation

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

  1 Year

Secondary Outcomes (2)

• Progression-free survival (PFS)

  1 Year

• Local Control Rate

  1 Year

Other Outcomes (4)

• Tumor Hypoxia Inducible Factor (HIF-1a) Marker Expression

  2 Years

• Radiosensitivity Marker Expression for Breast Cancer Gene (BRCA)

  2 Years

• Radiosensitivity Marker Expression for Mismatch Repair (MMR)

  2 Years

Study Arms (1)

Cesium-131 Brachytherapy

EXPERIMENTAL

Device: Cesium-131 Low Dose Radiation (LDR)

Interventions

Cesium-131 Low Dose Radiation (LDR) DEVICE

Placed one time by radiation oncologist under appropriate level of sedation as determined by anesthesiologist.

Cesium-131 Brachytherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Denise Fabian: lead

MeSH Terms

Interventions

Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Heather Pavlik

CONTACT

8593232354; heather.schroer@uky.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: June 8, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2030
• Last Updated: June 8, 2026

Record last verified: 2026-06