[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Denise Fabian\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100541561","phase-2-hypofractionated-radiochemotherapy-100541561",false,"NCT06331468","Hypofractionated Radiochemotherapy","Phase II Trial of Hypofractionated Radiochemotherapy for Women With Metastatic or Bulky Uterine Cervix Cancer","Inclusion Criteria:\n\n* Untreated, pathologically or cytologically-confirmed diagnosis of FIGO Stage IB3, II, or IIIA-IIIC1 bulky ( ≥ 6cm) or Stage IVA or Stage IVB (FIGO 2018) squamous, adenosquamous, or adenocarcinoma of the uterine cervix with limited metastatic burden (not requiring urgent systemic therapy).\n* Adequate organ and marrow function\n* Gynecologic Oncology Group performance status of 0, 1, or 2\n* Patient agrees to use two forms of birth control if they are of child-bearing potential\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Presence of another concurrent active invasive malignancy\n* 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\n* Receipt of prior pelvic radiotherapy for any reason that would contribute radiation dose that would exceed tolerance of normal tissues, at the discretion of the treating physician\n* Currently receiving any other investigational agent(s) for the treatment of cancer\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Cisplatin or other agents used in study\n* Presence of uncontrolled intercurrent illness as determined by the treating physician\n* pregnant or lactating\n* Patients with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better","FEMALE","18 Years","120 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this clinical trial is to investigate the use of hypofractionated radiation (delivery of fewer but larger doses of radiation) with concurrent chemotherapy for women with metastatic of bulky uterine cervix cancer. The main questions it aims to answer are:\n\n* What is the MRI-assessed rate of response at 1-month and 3-months post-treatment?\n* What is the safety and tolerability of cisplatin-based hypofractionated pelvic Intensity Modulated Radiation Therapy (IMRT) followed by brachytherapy?\n* What is the median progression-free survival and overall survival at 1 and 2 years for patients who undergo cisplatin-based hypofractionated pelvic IMRT?\n* What is the proportion of patients who complete the treatment in prescribed timeframe?\n* What the levels of cervix cancer circulating tumor cells pretherapy and after treatment?\n\nTo confirm eligibility, within four weeks prior to study enrollment, all patients will undergo the following:\n\n* Complete history and physical exam, GOG performance status evaluation\n* Standard of care scans, which include staging CTs and\u002For PET scans, and MRI to verify eligibility and appropriate stage of disease. Blood tests will be done to check various organ functions.\n\nTreatment will be administered on an outpatient basis.\n\nThe main difference between the proposed regimen in the trial and standard of care is as follows:\n\n1. The trial has a shortened course of EBRT. Standard of care utilizes 25 treatments, also known as \"fractions\" of EBRT, while the trial utilizes 8 fractions of EBRT. An equivalent \"biological effective dose\" is achieved by increasing the radiation dose per fraction.\n2. The concurrent cisplatin dosing is shortened from 5-6 cycles of cisplatin to 2 cycles of cisplatin. The dose of cisplatin is 40 mg\u002Fm2.\n\nThis protocol requires photon IMRT technique followed by high dose rate (HDR) brachytherapy. The therapies use focused energy beams to kill cancer cells. Radiation therapy must be completed within 30 days +\u002F- 2 days of initiation. Computed tomography simulation with the patient in a head-first laying on back-supine position is required. MRI-guided treatment planning and image guidance during treatment for motion management will be used.\n\nIMRT will be given once daily Monday-Thursday, four fractions per week. The high-dose-rate (HDR) brachytherapy following institutional protocol. Brachytherapy will be delivered twice per week with a 2-day break in between sessions. A total of four brachytherapy treatments will be delivered.\n\nAfter active therapy is completed, treatment-related toxicity will be assessed at the 1-month post-treatment completion visit and again at the 3-month post-treatment completion. Patients removed from the study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event(s).\n\nRoutine MRI imaging to assess treatment response to radiotherapy is conducted at Day 15. Treatment response to radiotherapy followed by brachytherapy will be assessed at the 1- month and 3-months post-treatment completion.\n\nFollowing the 3-months post-treatment completion, study participants will be followed for disease progression and survival status until Year 2 post-treatment initiation. NOTE: Cervical cancer patients are routinely followed (clinical surveillance) every 3-months during the first two years post-treatment.",[27],"Uterine Cervix Cancer",[29,30],"Uterine Neoplasm","Cisplatin","RECRUITING","2026-06-09",{"date":34,"type":35},"2026-06-10","ACTUAL",{"date":37,"type":35},"2025-06-26",{"date":39,"type":21},"2028-07-01",{"name":41,"class":42},"Denise Fabian","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100643492","cs-131ldr-brachytherapy-for-organ-preserving-irradiation-for-recurrent-cervical-and-endometrial-cancer-100643492","NCT07631572","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","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.",{"count":52,"type":21},10,[54],"NA","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",[57],"Gynecologic Cancer",[59],"Cesium","NOT_YET_RECRUITING","2026-06-01",{"date":63,"type":35},"2026-06-08",{"date":65,"type":21},"2026-06",{"date":67,"type":21},"2030-05",{"name":41,"class":42},""]