NCT07631572Recruiting
Cs-131LDR Brachytherapy for Organ-Preserving Irradiation for Recurrent Cervical and Endometrial Cancer
Phase II Clinical Trial of Cesium-131 Low-dose Rate Interstitial Brachytherapy as an Organ-preserving Irradiation Technique for Recurrent Cervical and Endometrial Cancer
Source: ClinicalTrials.gov · Last updated 31 Aug 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 30 Apr 2026
- Start date
- Oct 2026
- Primary completion date
- May 2029
- Lead sponsor
- Denise Fabian
- Diseases
- Endometrial cancer
- NCT number
- NCT07631572
What you commit to
- Study type: Interventional
- Planned participants: 10
- From Oct 2026 to the primary completion date, May 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Other illness
- 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.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Cesium-131 implant or other agents used in this study.
Other
- Receipt of epoetin alpha (Procrit, Epogen) within 1 month of study screening.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Kentucky/Markey Cancer Center Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.