Gynecologic CancerNCT07631572
Cs-131LDR Brachytherapy for Organ-Preserving Irradiation for Recurrent Cervical and Endometrial Cancer
A study testing Cesium-131 Low Dose Radiation (LDR) in people with Gynecologic Cancer, run by Denise Fabian at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancer
- What is being tested?
- Cesium-131 Low Dose Radiation (LDR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kentucky Markey Cancer Center
Lexington, Kentucky, 40506
About this study
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
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
- Being tested
- Cesium-131 Low Dose Radiation (LDR)
- Keywords
- Cesium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cesium-131 Low Dose Radiation (LDR)Device
Placed one time by radiation oncologist under appropriate level of sedation as determined by anesthesiologist.
| Study group | Role | What they receive |
|---|---|---|
| Cesium-131 Brachytherapy | Experimental | Not described Receives: Device: Cesium-131 Low Dose Radiation (LDR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Year
Secondary outcomes (2)
Progression-free survival (PFS)
PFS using RECIST 1.1
Measured: 1 Year
Local Control Rate
Local control using combination of imaging and physical exams
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study startOct 2026 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Denise Fabian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Denise Fabian, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631572
- Sponsor's protocol ID
- MCC-25-GYN-12
- Status last verified
- Aug 2026
- First submitted
- 30 Apr 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07631572
- Acronym / sponsor ID
- MCC-25-GYN-12
- Conditions
- Gynecologic Cancer
- Keywords
- Cesium
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Denise FabianUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cesium-131 Brachytherapy | Experimental | Device: Cesium-131 Low Dose Radiation (LDR) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cesium-131 Low Dose Radiation (LDR)Placed one time by radiation oncologist under appropriate level of sedation as determined by anesthesiologist. | Device | Cesium-131 Brachytherapy |
Primary outcome
Proportion of participants with organ preservation
Time frame: 1 Year
Organ preservation rate is defined as avoidance of pelvic exenteration and organ sacrificing surgeries including total vaginectomy, cystectomy and anterior perineal resection.
2 secondary outcomes
Progression-free survival (PFS)
Time frame: 1 Year
Local Control Rate
Time frame: 1 Year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
Related trials for Gynecologic Cancer
RecruitingPhase 2
Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)
Malignant Female Reproductive System Neoplasm, Malignant Solid Neoplasm
Recruiting
INtegrating Systematic PatIent-Reported Evaluations in Multi-Disciplinary Tumor Boards: The INSPIRE Study
Breast Cancer, Corpus Uteri Cancer
Not yet recruiting
Gut Microbiome in Patients With Lung and Melanoma Cancer and Intestinal Microbiota in Gynecologic Cancers
Non Small Cell Lung Cancer, Melanoma (Skin Cancer)
Enrolling by invitation
Peer Ambassador in Gyn Onc Trials
Ovarian Cancer
RecruitingObservational study
Surgical Thromboprophylaxis Practices in Oncology Patients Within the NCORP Network, STOP-VTE Study
Malignant Digestive System Neoplasm, Malignant Female Reproductive System Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cesium-131 Low Dose Radiation (LDR) in people with Gynecologic Cancer, run by Denise Fabian at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather Pavlik (8593232354, heather.schroer@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with organ preservation (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.