[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100505152":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":37,"centralContacts":42,"locations":48,"responsibleParty":79,"collaborators":46,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":46,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":102,"overallStatus":51,"whyStopped":46,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Tata Memorial Centre","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Hypofractionated Image guided External Beam Radiation","EXPERIMENTAL","Adjuvant hypofractionated external beam radiotherapy for post operative patients with cervical or endometrial cancer.",[13,14,15],"Radiation: Hypofractionated Image guided External Beam Radiation Therapy (EBRT)","Drug: Cisplatin","Radiation: Vaginal brachytherapy",[17,24,31],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"RADIATION","Hypofractionated Image guided External Beam Radiation Therapy (EBRT)","External beam radiotherapy to pelvis:\n\nPost operative hypofractionated external beam radiotherapy with intensity modulated\u002Farc technique, to a dose of 39 Gy in 13 fractions, at 3 Gy per fraction, delivered once daily, 5 days a week, over 2.5-3 weeks.",[9],[23],"Radiotherapy",{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Cisplatin","Patients who require adjuvant chemotherapy along with radiation, based on predefined risk features, will receive 5 cycles of cisplatin on a weekly basis with a dose of 40 mg\u002Fm2 by IV infusion over a period of 1 hour 2-4 hours prior to start of EBRT.",[9],[30],"Chemotherapy",{"type":18,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Vaginal brachytherapy","Vaginal brachytherapy, two fractions of 6 Gy each, delivered 1 week apart.",[9],[36],"Brachytherapy",[38],{"name":39,"affiliation":40,"role":41},"Dr. Prachi D Mittal, MD","Tata Memorial Hospital","PRINCIPAL_INVESTIGATOR",[43],{"name":39,"role":44,"phone":45,"phoneExt":46,"email":47},"CONTACT","+91 9004938871",null,"mittalprachi@gmail.com",[49,68],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Advanced Centre for Treatment Research and Education in Cancer (ACTREC)","RECRUITING","Navi Mumbai","Maharahstra","410210","India","IN",{"type":58,"coordinates":59},"Point",[60,61],73.01582,19.03681,{"lat":61,"lon":60},[64],{"name":65,"role":44,"phone":66,"phoneExt":67,"email":47},"Prachi Mittal, MD","+912224177000","7033",{"facility":40,"status":51,"city":69,"state":70,"zip":71,"country":55,"countryCode":56,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Mumbai","Maharashtra","400012",{"type":58,"coordinates":73},[74,75],72.88261,19.07283,{"lat":75,"lon":74},[78],{"name":65,"role":44,"phone":66,"phoneExt":67,"email":47},{"type":41,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":46,"oldOrganization":46},"Prachi Mittal, MD, Radiation Oncology","Assistant Professor","100505152","postoperative-hypofractionated-radiation-in-cervical-and-endometrial-tumours-phase-ii-study-100505152",false,"NCT05857631","Postoperative Hypofractionated Radiation in Cervical and Endometrial Tumours: Phase II Study","PARCERII","Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n2. Histologically confirmed diagnosis of cervical cancer post hysterectomy with intermediate or high-risk features, requiring adjuvant EBRT ± concurrent chemotherapy OR histologically confirmed diagnosis of endometrial cancer post hysterectomy requiring adjuvant (chemo)radiotherapy to pelvis with\u002Fwithout vaginal brachytherapy.\n\nExclusion Criteria:\n\n1. Patients with macroscopic residual disease (R+ resection) postoperatively\n2. Patients requiring extended field radiotherapy (patients with involved para-aortic lymph nodes in cervical or endometrial cancer)\n3. Patients treated with chemotherapy for any prior malignancy at any time\n4. Patients treated with pelvic radiation previously\n5. Patients with human immunodeficiency virus infection\n6. Any preexisting medical conditions that may interfere with the assessment of genitourinary or gastrointestinal toxicity (This includes patients with irritable bowel syndrome, subacute intestinal obstruction, anal incontinence, hemorrhoids precluding analysis of gastro-intestinal toxicities, urinary incontinence, recurrent urinary tract infections)","FEMALE","18 Years","80 Years",{"count":93,"type":94},90,"ESTIMATED","INTERVENTIONAL",[97],"NA","The primary aim of the trial is to investigate the late effects of hypofractionated external radiation (39 Gy in 13 fractions) in patients requiring post-operative radiation for early-stage cervical and endometrial cancers.",[100,101],"Cervical Cancer","Endometrial Cancer",[103,104,105,106],"Hypofractionated Radiation","Radiotherapy, Adjuvant","Radiotherapy, Intensity modulated","Late gastrointestinal and genitourinary toxicities","2025-04-10",{"date":109,"type":110},"2025-04-15","ACTUAL",{"date":112,"type":110},"2023-05-29",{"date":114,"type":94},"2029-05-25",{"name":5,"class":6},2]