[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07631572":3,"trial-entities:NCT07631572":87,"trial-summary:NCT07631572":92},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":10,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":14,"conditions":16,"keywords":18,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":39,"sex":46,"minimum_age":47,"maximum_age":14,"healthy_volunteers":48,"eligibility_criteria":49,"std_ages":65,"locations":68,"central_contacts":78,"overall_officials":84,"references":85,"see_also_links":86},"NCT07631572","MCC-25-GYN-12","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","RECRUITING","2030-05","2026-07","2026-07-10","Denise Fabian","OTHER",null,"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",[17],"Gynecologic Cancer",[19],"Cesium","INTERVENTIONAL","TREATMENT",[23],"NA",{"count":25,"type":26},10,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DEVICE","Cesium-131 Low Dose Radiation (LDR)","Placed one time by radiation oncologist under appropriate level of sedation as determined by anesthesiologist.",[33],"Cesium-131 Brachytherapy",[35],{"measure":36,"description":37,"timeFrame":38},"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",[40,43],{"measure":41,"description":42,"timeFrame":38},"Progression-free survival (PFS)","PFS using RECIST 1.1",{"measure":44,"description":45,"timeFrame":38},"Local Control Rate","Local control using combination of imaging and physical exams","FEMALE","18 Years",false,{"inclusion":50,"exclusion":58,"raw_text":64},[51,52,53,54,55,56,57],"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\u002Fmarrow function requirements because patients will not be receiving systemic therapy.","Ability to understand and the willingness to sign a written informed consent document.",[59,60,61,62,63],"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\u002For \\[b\\] prior in situ carcinoma of the cervix and\u002For \\[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.","Inclusion Criteria:\n\n* 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.\n* Patients must have vaginal recurrence that is amenable to cesium implant for salvage\n* 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.\n* 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.\n* Gynecologic Oncology Group performance status of 0, 1, or 2 (see Appendix A).\n* There are no minimum organ\u002Fmarrow function requirements because patients will not be receiving systemic therapy.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* 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\u002For \\[b\\] prior in situ carcinoma of the cervix and\u002For \\[c\\] in situ bladder cancer.\n* 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.\n* Receipt of epoetin alpha (Procrit, Epogen) within 1 month of study screening.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Cesium-131 implant or other agents used in this study.\n* 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.",[66,67],"ADULT","OLDER_ADULT",[69],{"facility":70,"status":8,"city":71,"state":72,"zip":73,"country":74,"geoPoint":75},"University of Kentucky Markey Cancer Center","Lexington","Kentucky","40506","United States",{"lat":76,"lon":77},37.98869,-84.47772,[79],{"name":80,"role":81,"phone":82,"email":83},"Heather Pavlik","CONTACT","8593232354","heather.schroer@uky.edu",[],[],[],{"nct_id":4,"conditions":88,"biomarkers":91},[89,90],"Cervical Carcinoma","Endometrial Carcinoma",[],{"nct_id":4,"found":93,"summary":94,"prompt_version":104},true,{"design":95,"status":96,"heading":97,"summary":98,"follow_up":99,"word_count":100,"commitments":101,"compensation":102,"drugs_mentioned":103},"This is an interventional study, meaning participants will receive a specific treatment. It is planned to include 10 participants.","completed","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.","The main goal of the study is measured at 1 year to see if organs are preserved.",124,"Participants will have a Cesium-131 LDR device placed one time by a radiation oncologist under sedation.","Not stated in the trial record.",[30],"v2"]