[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614189":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":101,"centralContacts":105,"locations":111,"responsibleParty":128,"collaborators":130,"id":137,"slug":138,"hasResults":139,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":139,"sex":145,"minAge":146,"maxAge":109,"enrollmentInfo":147,"targetDuration":109,"studyType":150,"phases":151,"briefSummary":153,"conditions":154,"keywords":160,"overallStatus":113,"whyStopped":109,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},{"fullName":5,"class":6},"Uganda Cancer Institute","OTHER",[8,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm I (HFRT)","EXPERIMENTAL","Patients undergo HFRT QD, Monday-Friday, for 5 fractions weekly for 16 fractions in the absence of disease progression or unacceptable toxicity. Starting on day 1 of radiation therapy, patients receive cisplatin infusion over 1 hour QW during radiation therapy. Starting by week 4, patients may also undergo HDR brachytherapy twice weekly for a total of 4 doses. Patients ineligible for brachytherapy undergo a sequential external beam boost. Additionally, patients undergo CT and blood sample collection throughout the study.",[13,14,15,16,17,18,19],"Radiation: Hypofractionated Radiation Therapy","Drug: Cisplatin","Radiation: High-Dose Rate Brachytherapy","Radiation: External Beam Radiotherapy Boost","Procedure: Computed Tomography","Procedure: Biospecimen Collection","Other: Questionnaire and Physical Exam",{"label":21,"type":22,"description":23,"interventionNames":24},"Arm II (CFRT)","ACTIVE_COMPARATOR","Patients undergo CFRT QD, Monday-Friday, for 5 fractions weekly for up to 25 fractions in the absence of disease progression or unacceptable toxicity. Starting on day 1 of radiation therapy, patients receive cisplatin infusion over 1 hour QW during radiation therapy. Starting by week 4, patients may also undergo HDR brachytherapy twice weekly for a total of 4 doses. Patients ineligible for brachytherapy undergo a sequential external beam boost. Additionally, patients undergo CT and blood sample collection throughout the study.",[25,14,15,16,17,18,19],"Radiation: Conventional Fractionated Radiotherapy",[27,37,44,53,62,71,83,92],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"RADIATION","Hypofractionated Radiation Therapy","Undergoing HFRT - The prescription dose will be 40 Gy in 16 fractions (2.5 Gy\u002Ffraction) to the entire pelvis, with concurrent integrated nodal boost at 3.0 Gy per fraction (48 Gy) to involved (positive) pelvic nodes, delivered once a day, Monday through Friday, 5 fractions per week, using volumetric modulated arc therapy (VMAT).",[9],[33,34,35,36],"Hypofractionated","hypofractionated radiotherapy","Hypofractionation","Moderately Hypofractionated Radiotherapy",{"type":28,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Conventional Fractionated Radiotherapy","Undergoing CFRT",[21],[42,43],"Normofractionated Radiotherapy","Conventionally Fractionated Radiotherapy",{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"DRUG","Cisplatin","Undergoing Cisplatin",[9,21],[50,51,52],"CDDP","Abiplatin","Platinum",{"type":28,"name":54,"description":55,"armGroupLabels":56,"otherNames":57},"High-Dose Rate Brachytherapy","Undergoing HDR Brachytherapy",[9,21],[58,59,60,61],"Brachytherapy","HDR","HDR Brachytherapy","High dose brachytherapy",{"type":28,"name":63,"description":64,"armGroupLabels":65,"otherNames":66},"External Beam Radiotherapy Boost","Undergoing external beam radiotherapy boost",[9,21],[67,68,69,70],"Boost","EBRT Boost","Boost Radiotherapy","Radiotherapy Boost",{"type":72,"name":73,"description":74,"armGroupLabels":75,"otherNames":76},"PROCEDURE","Computed Tomography","Undergoing CT scan",[9,21],[77,78,79,80,81,82],"CAT scan","CAT","Planning CT scan","CT scan","Computed Axial Tomography","Computed Axial Tomography Scan",{"type":72,"name":84,"description":85,"armGroupLabels":86,"otherNames":87},"Biospecimen Collection","Undergoing blood sample collection",[9,21],[88,89,90,91],"Blood sample","Biological sample collection","Biospecimen collected","Specimen collection",{"type":6,"name":93,"description":94,"armGroupLabels":95,"otherNames":96},"Questionnaire and Physical Exam","Ancillary Studies",[9,21],[97,98,99,100],"CRF","Questionnaire","Assessment","Physical Exam",[102],{"name":103,"affiliation":5,"role":104},"Solomon Kibudde, MBChB, MMed.","PRINCIPAL_INVESTIGATOR",[106],{"name":103,"role":107,"phone":108,"phoneExt":109,"email":110},"CONTACT","+256773004608",null,"solomon.kibudde@uci.or.ug",[112],{"facility":5,"status":113,"city":114,"state":114,"zip":115,"country":116,"countryCode":117,"cosmosGeoPoint":118,"geoPoint":123,"contacts":124},"RECRUITING","Kampala","256","Uganda","UG",{"type":119,"coordinates":120},"Point",[121,122],32.58219,0.31628,{"lat":122,"lon":121},[125],{"name":126,"role":107,"phone":127,"phoneExt":109,"email":110},"Solomon Kibudde, MBChB, MMed","0773004608",{"type":129,"investigatorFullName":109,"investigatorTitle":109,"investigatorAffiliation":109,"oldNameTitle":109,"oldOrganization":109},"SPONSOR",[131,134],{"name":132,"class":133},"Varian Medical Systems","INDUSTRY",{"name":135,"class":136},"Fogarty International Center of the National Institute of Health","NIH","100614189","phase-2-hypofractionated-radiotherapy-for-the-treatment-of-locally-advanced-cervical-cancer-in-uganda-100614189",false,"NCT07276360","Hypofractionated Radiotherapy for the Treatment of Locally Advanced Cervical Cancer in Uganda","Phase II Randomized Non-Inferiority Trial of Hypofractionated Radiotherapy for Locally Advanced Cervical Cancer in Uganda","HypoRTCx-UG","Inclusion Criteria:\n\n* Females aged 18 years or older\n* Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the uterine cervix without prior treatment\n* Federation of Gynecology and Obstetrics (FIGO) 2018 stage IB3, IIA, IIB, IIIA, IIIB, or IIIC\n* Able to provide written informed consent in English, Luganda, Runyankole, or Lango\n* Willing to attend post-treatment follow-up for up to 12 months\n* Fit for concurrent chemotherapy with cisplatin\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 2\n* Absolute neutrophil count ≥ 1,500 cells\u002Fmm\\^3 (1.5 x 10\\^9\u002FL)\n* Platelets ≥ 100,000 cells\u002Fmm\\^3 (100 x 10\\^9\u002FL)\n* Hemoglobin ≥ 9.0 g\u002FdL\n* Leukocyte count ≥ 4,000 cells\u002Fmm\\^3 (4.0 x 10\\^9\u002FL)\n* Creatinine clearance \\> 60 mL\u002Fmins, calculated using the Cockcroft-gault equation for women\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 3 times the upper limit of normal (ULN)\n* Total bilirubin \\\u003C 2 x ULN unless attributed to the use of antiretroviral therapy (ART)\n* HIV-positive participants must be on a stable ART regimen for at least 6 weeks prior to enrollment\n\nExclusion Criteria:\n\n* Prior hysterectomy. Women with previous total or subtotal hysterectomy have no cervix, and hence the anatomical changes have an impact on the radiotherapy field, and dose prescriptions because they tend to have a higher risk for bowel toxicity from pelvic radiotherapy. Therefore, these women will be excluded due to the likely impact on the results of our study intervention\n* Clinical and\u002For radiological evidence of distant metastases\n* Prior pelvic or abdominal radiotherapy\n* Presence of bilateral hip prosthesis that could interfere with radiotherapy treatment\n* History of inflammatory bowel disease or any other condition that could complicate radiotherapy treatment\n* Participants who are pregnant at the time of enrollment. Pregnant women have a potential risk of radiation exposure to developing fetus, which may result in fetal malformations, growth retardation, or even fatal death. Secondly, their physiological changes alter the pharmacokinetics and pharmacodynamics of concurrent chemotherapy. Therefore, to protect the health of the mother and the unborn child, pregnant women will be excluded from the study. Patients who are found to be pregnant after enrollment will have the study procedures terminated\n* Concurrent untreated invasive malignancy\n* Uncontrolled concurrent medical\u002Fpsychiatric diagnosis that would limit compliance with study requirements\n* Uncontrolled HIV infection, especially HIV viral load \\> 2,000 copies\u002FmL\n* Participants with CD4 counts \\\u003C 200 cells\u002Fmm\\^3","FEMALE","18 Years",{"count":148,"type":149},278,"ESTIMATED","INTERVENTIONAL",[152],"PHASE2","This phase II trial compares the effect of hypofractionated radiotherapy (HFRT) to conventional fractionated radiotherapy (CFRT) when given in combination with cisplatin and brachytherapy in patients with stage IB3, II, or III cervical cancer. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. CFRT delivers the total dose of radiation over the amount of time according to standard practice. HFRT delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. HFRT shortens treatment duration and may reduce costs and may improve the completion rates. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. HFRT may be safe, tolerable, and\u002For as effective as CFRT when given in combination with cisplatin and brachytherapy in treating patients with stage IB3, II or III cervical cancer.",[155,156,157,158,159],"Cervical Cancer","Cervix Cancer","Cervical Adenocarcinoma","Cervical Small Cell Carcinoma","Cervical Adenosquamous Carcinoma",[161,162,35,116],"Cervical cancer","Radiotherapy","2026-03-26",{"date":165,"type":166},"2026-03-27","ACTUAL",{"date":168,"type":166},"2026-03-11",{"date":170,"type":149},"2029-01-02",{"name":5,"class":6},1]