[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553723":3},{"organization":4,"outcomesModule":7,"designInfo":56,"detailedDescription":63,"studyPopulation":55,"armGroups":64,"interventions":76,"overallOfficials":86,"centralContacts":91,"locations":102,"responsibleParty":316,"collaborators":319,"id":322,"slug":55,"hasResults":323,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":327,"eligibilityCriteria":328,"healthyVolunteers":323,"sex":329,"minAge":330,"maxAge":55,"enrollmentInfo":331,"targetDuration":55,"studyType":334,"phases":335,"briefSummary":337,"conditions":338,"keywords":340,"overallStatus":105,"whyStopped":55,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":356},{"fullName":5,"class":6},"Hannover Medical School","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":55},[9],{"measure":10,"description":11,"timeFrame":12},"Disease-free survival","Disease-free survival (DFS) is defined as the time from randomization to disease recurrence or death from any course (whichever occurs first). The date of disease recurrence is defined as the date of biopsy.","up to year 5",[14,17,21,24,27,30,33,36,39,43,46,49,52],{"measure":15,"description":16,"timeFrame":12},"Overall survival","Overall survival (OS) is defined as the time from randomization to death from any cause.",{"measure":18,"description":19,"timeFrame":20},"Disease recurrence","The date of recurrence of disease is defined as the date of biopsy. A suspicion of disease recurrence (clinical or by imaging) should be verified by histopathological assessment. Disease recurrence will be assessed and recorded at each follow-up visit starting 6 months post-surgery.","up to year 5 starting 6 months post-surgery",{"measure":22,"description":23,"timeFrame":12},"Health Related Quality of Life (HRQoL): Core questionnaire","Health Related Quality of Life (HRQoL) will be assessed by using the validated questionnaire European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-30)",{"measure":25,"description":26,"timeFrame":12},"Health Related Quality of Life (HRQoL): Cervical cancer questionnaire","Health Related Quality of Life (HRQoL) will be assessed by using the validated questionnaire EORTC QLQ Cervical Cancer Module (EORTC QLQ-CX24)",{"measure":28,"description":29,"timeFrame":12},"Health Related Quality of Life (HRQoL): General health status","Health Related Quality of Life (HRQoL) will be assessed by using the validated questionnaire EuroQoL EQ-5D-3L",{"measure":31,"description":32,"timeFrame":12},"Health Related Quality of Life (HRQoL): Sexual activity","Health Related Quality of Life (HRQoL) will be assessed by using the validated sexual activity questionnaires (SAQ).",{"measure":34,"description":35,"timeFrame":12},"Lymphatic side effects: Investigator assessment","Lymphatic side effects will be assessed by the investigator using Common Terminology Criteria for Adverse Events (CTCAE 3.0)",{"measure":37,"description":38,"timeFrame":12},"Lymphatic side effects: Patient assessment","Lymphatic side effects will be assessed by the patient using the Lymphoedema Quality-of-Life (LYMQOL) questionnaire.",{"measure":40,"description":41,"timeFrame":42},"Complications and treatment-associated morbidity","Treatment-related intraoperative complications are recorded on the day of surgery according to Rosenthal's definition.\n\nTreatment-related postoperative complications are recorded from the day of surgery until one year after surgery.","up to one year after surgery",{"measure":44,"description":45,"timeFrame":42},"Serious adverse events","Serious adverse events (SAEs) will be captured from the day of surgery until one year post surgery. Treatment-related SAEs are documented as intra-\u002Fpostoperative complications according to Outcome 5.",{"measure":47,"description":48,"timeFrame":12},"Health care costs: Cost-effectiveness","Cost-effectiveness will be determined as incremental cost-effectiveness ratios.",{"measure":50,"description":51,"timeFrame":12},"Health care costs: Direct cost assessment","Direct costs will be assessed via internal accounting and billing systems within the hospitals.",{"measure":53,"description":54,"timeFrame":12},"Health care costs: Cost-utility analysis","Quality-adjusted life years (QALY) calculations will be used for a cost-utility analysis.",null,{"allocation":57,"interventionModel":58,"interventionModelDescription":59,"primaryPurpose":60,"observationalModel":55,"timePerspective":55,"maskingInfo":61},"RANDOMIZED","PARALLEL","Interventional, multicenter, open-label, randomized, controlled non-inferiority trial","TREATMENT",{"masking":62,"maskingDescription":55,"whoMasked":55},"NONE","Eligible patients will be randomly allocated to both treatment arms in a 1:1 ratio. Within an accrual period of 4 years, 378 patients will be included per arm (756 in total) across all sites. The Follow-up period after surgery will take a minimum of 5 years.\n\nIn the standard arm, radical hysterectomy is performed as per standard technique abdominal radical hysterectomy (Piver type 2 or 3 or Querleu \\& Morrow Type B or C) with salpingectomy +\u002F- oophorectomy. Ovaries may be removed or preserved +\u002F- transposition. Surgery includes pelvic lymph node dissection or optional sentinel lymph node biopsy (SNB) according to current guidelines in both arms.\n\nIn the experimental arm, radical hysterectomy is performed as per standard conventional 2D\u002F3D laparoscopic or robotic assisted technique (Querleu \\& Morrow Type B or C) with salpingectomy +\u002F- oophorectomy. Ovaries may be removed or preserved +\u002F- transposition. The following protective measures are mandatory for the minimally invasive arm: LEEP\u002Fconization prior to randomization or vaginal closure prior to colpotomy. Transcervical manipulators are not permitted. Use of uterus manipulators\u002F cervical adapter (without transcervical device) is allowed only after LEEP\u002Fconization. Meticulous dissection of pelvic (sentinel) lymph nodes including use of endobags and avoiding the dissemination of cancer cells will be implemented (tumor hygiene).\n\nDue to the positive results of the SHAPE trial published at Plante et al. NEJM 2024, in both arms simple hysterectomy can be considered for patients with low-risk early-stage cervical cancer (SHAPE criteria: tumor \\\u003C 2 cm, \\\u003C 10 mm depth of stromal invasion (LEEP\u002Fcone) BUT has to be determined BEFORE randomization. Simple hysterectomy has to be performed as extrafascial hysterectomy and the preparation of a max. 5 mm vaginal cuff is required to ensure negative margins. Surgery can be performed including removal of the sentinel lymph nodes following the concept of sentinel lymph node biopsy (SNB) and according to the current guidelines.",[65,71],{"label":66,"type":67,"description":68,"interventionNames":69},"Experimental intervention: Laparoscopic or robot-assisted radical\u002Fsimple hysterectomy","EXPERIMENTAL","In the experimental arm, patients with early-stage cervical cancer will be treated by using laparoscopic or robot-assisted radical\u002Fsimple hysterectomy.",[70],"Procedure: Laparoscopic or robot-assisted radical\u002Fsimple hysterectomy",{"label":72,"type":6,"description":73,"interventionNames":74},"Control intervention: Abdominal radical\u002Fsimple hysterectomy","In the control arm, abdominal radical\u002Fsimple hysterectomy (ARH) will be used as standard therapy.",[75],"Procedure: Abdominal radical\u002Fsimple hysterectomy",[77,82],{"type":78,"name":79,"description":80,"armGroupLabels":81,"otherNames":55},"PROCEDURE","Laparoscopic or robot-assisted radical\u002Fsimple hysterectomy","In the experimental arm, patients with early-stage cervical cancer will be treated by using laparoscopic or robot-assisted radical, or in the case of SHAPE criteria, simple hysterectomy.",[66],{"type":78,"name":83,"description":84,"armGroupLabels":85,"otherNames":55},"Abdominal radical\u002Fsimple hysterectomy","In the control arm, patients with early-stage cervical cancer will be treated by using abdominal radical, or in the case of SHAPE criteria, simple hysterectomy as standard therapy.",[72],[87],{"name":88,"affiliation":89,"role":90},"Peter Hillemanns, Prof. Dr.","Hannover Medical School, Department of Gynecology and Obstetrics","PRINCIPAL_INVESTIGATOR",[92,97],{"name":88,"role":93,"phone":94,"phoneExt":95,"email":96},"CONTACT","+49 (0) 511 532","6144","frauenklinik@mh-hannover.de",{"name":98,"role":93,"phone":99,"phoneExt":100,"email":101},"Oliver Papp","+49 (0) 176 1532","7234","g-lacc.zks@mh-hannover.de",[103,122,137,153,169,182,197,213,228,243,259,275,286,301],{"facility":104,"status":105,"city":106,"state":107,"zip":108,"country":109,"countryCode":110,"cosmosGeoPoint":111,"geoPoint":116,"contacts":117},"Ludwigsburg Hospital, Department of Gynecology and Obstetrics","RECRUITING","Ludwigsburg","Baden-Wurttemberg","71640","Germany","DE",{"type":112,"coordinates":113},"Point",[114,115],9.19161,48.89731,{"lat":115,"lon":114},[118],{"name":119,"role":93,"phone":120,"phoneExt":121,"email":55},"Sebastian Berlit, Prof. Dr.","+49 (0) 7141 99","67601",{"facility":123,"status":105,"city":124,"state":107,"zip":125,"country":109,"countryCode":110,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"University Medical Center Tübingen, Department of Gynecology","Tübingen","72076",{"type":112,"coordinates":127},[128,129],9.05222,48.52266,{"lat":129,"lon":128},[132],{"name":133,"role":93,"phone":134,"phoneExt":135,"email":136},"Sara Y. Brucker, Prof. Dr.","+49 (0) 7071 29","80791","frauenklinik@med.uni-tuebingen.de",{"facility":138,"status":105,"city":139,"state":140,"zip":141,"country":109,"countryCode":110,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"Hochtaunus-Clinics Bad Homburg, Department of Gynecology","Bad Homburg","Hesse","61352",{"type":112,"coordinates":143},[144,145],8.61816,50.22683,{"lat":145,"lon":144},[148],{"name":149,"role":93,"phone":150,"phoneExt":151,"email":152},"Dominik Denschlag, Prof. Dr.","+49 (0) 6172 14","2580","sekretariat-frauenklinik@hochtaunus-kliniken.de",{"facility":154,"status":105,"city":155,"state":156,"zip":157,"country":109,"countryCode":110,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"University Medical Center Göttingen, Department of Gynecology and Obstetrics","Göttingen","Lower Saxony","37075",{"type":112,"coordinates":159},[160,161],9.93228,51.53443,{"lat":161,"lon":160},[164],{"name":165,"role":93,"phone":166,"phoneExt":167,"email":168},"Julia Gallwas, Prof. Dr.","+49 (0) 551 396","2501","direktion.ufk@med.uni-goettingen.de",{"facility":89,"status":105,"city":170,"state":156,"zip":171,"country":109,"countryCode":110,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"Hanover","30625",{"type":112,"coordinates":173},[174,175],9.73322,52.37052,{"lat":175,"lon":174},[178,179],{"name":88,"role":93,"phone":94,"phoneExt":95,"email":96},{"name":180,"role":93,"phone":94,"phoneExt":181,"email":96},"Hermann Hertel, Prof. Dr.","9760",{"facility":183,"status":105,"city":184,"state":156,"zip":185,"country":109,"countryCode":110,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"Hospital Lüneburg, Department of Gynecology","Lüneburg","21339",{"type":112,"coordinates":187},[188,189],10.41548,53.25122,{"lat":189,"lon":188},[192],{"name":193,"role":93,"phone":194,"phoneExt":195,"email":196},"Peter Dall, Prof. Dr.","+49 (0) 4131 77","2231","frauenklinik@klinikum-lueneburg.de",{"facility":198,"status":105,"city":199,"state":200,"zip":201,"country":109,"countryCode":110,"cosmosGeoPoint":202,"geoPoint":206,"contacts":207},"Hospital Bielefeld - Center, Department of Gynecology","Bielefeld","North Rhine-Westphalia","33604",{"type":112,"coordinates":203},[204,205],8.53333,52.03333,{"lat":205,"lon":204},[208],{"name":209,"role":93,"phone":210,"phoneExt":211,"email":212},"Werner Bader, Prof. Dr.","+49 (0) 521 581","3271","frauenklinik@klinikumbielefeld.de",{"facility":214,"status":105,"city":215,"state":200,"zip":216,"country":109,"countryCode":110,"cosmosGeoPoint":217,"geoPoint":221,"contacts":222},"University Medical Center Düsseldorf, Department of Gynecology and Obstetrics","Düsseldorf","40225",{"type":112,"coordinates":218},[219,220],6.77927,51.22319,{"lat":220,"lon":219},[223],{"name":224,"role":93,"phone":225,"phoneExt":226,"email":227},"Tanja Fehm, Prof. Dr.","+49 (0) 211 81","17501","direktion.frauenklinik@med.uni-duesseldorf.de",{"facility":229,"status":105,"city":230,"state":200,"zip":231,"country":109,"countryCode":110,"cosmosGeoPoint":232,"geoPoint":236,"contacts":237},"Protestant Hospital Wesel, Gynecological Cancer Center","Wesel","46485",{"type":112,"coordinates":233},[234,235],6.62037,51.6669,{"lat":235,"lon":234},[238],{"name":239,"role":93,"phone":240,"phoneExt":241,"email":242},"Nicole Sigrist-Uhl","+49 (0) 281 106","2700","gynaekologie@evkwesel.de",{"facility":244,"status":105,"city":245,"state":246,"zip":247,"country":109,"countryCode":110,"cosmosGeoPoint":248,"geoPoint":252,"contacts":253},"University Medical Center Mainz, Department of Obstetrics and Gynecology","Mainz","Rhineland-Palatinate","55131",{"type":112,"coordinates":249},[250,251],8.28008,49.98185,{"lat":251,"lon":250},[254],{"name":255,"role":93,"phone":256,"phoneExt":257,"email":258},"Roxana Schwab, PD Dr.","+49 (0) 6131 17","7574","uct-hotline@unimedizin-mainz.de",{"facility":260,"status":105,"city":261,"state":262,"zip":263,"country":109,"countryCode":110,"cosmosGeoPoint":264,"geoPoint":268,"contacts":269},"University Hospital Schleswig-Holstein, Campus Kiel, Department of Gynecology and Obstetrics","Kiel","Schleswig-Holstein","24105",{"type":112,"coordinates":265},[266,267],10.13489,54.32133,{"lat":267,"lon":266},[270],{"name":271,"role":93,"phone":272,"phoneExt":273,"email":274},"Ibrahim Alkatout, Prof. Dr.","+49 (0) 431 500","21407","Frauenklinik.Kiel@uksh.de",{"facility":276,"status":105,"city":277,"state":278,"zip":279,"country":109,"countryCode":110,"cosmosGeoPoint":55,"geoPoint":55,"contacts":280},"Vivantes Auguste-Viktoria-Hospital, Department of Gynecology","Berlin Schöneberg","State of Berlin","12157",[281],{"name":282,"role":93,"phone":283,"phoneExt":284,"email":285},"Farnaz Jakubek","+49 (0) 30 130 20","2402","gyn-ambulanz.avk@vivantes.de",{"facility":287,"status":105,"city":288,"state":55,"zip":289,"country":109,"countryCode":110,"cosmosGeoPoint":290,"geoPoint":294,"contacts":295},"Martin Luther Hospital Berlin, Department of Gynecology and Obstetrics","Berlin","14193",{"type":112,"coordinates":291},[292,293],13.41053,52.52437,{"lat":293,"lon":292},[296],{"name":297,"role":93,"phone":298,"phoneExt":299,"email":300},"Uwe A. Ulrich, Prof. Dr.","+49 (0) 30 8955","3311","gynaekologie.martin-luther@jsd.de",{"facility":302,"status":105,"city":303,"state":55,"zip":304,"country":109,"countryCode":110,"cosmosGeoPoint":305,"geoPoint":309,"contacts":310},"University Medical Center Hamburg-Eppendorf, Department of Gynecology","Hamburg","20246",{"type":112,"coordinates":306},[307,308],9.99302,53.55073,{"lat":308,"lon":307},[311],{"name":312,"role":93,"phone":313,"phoneExt":314,"email":315},"Jan Dieckmann, Dr.","+49 (0) 40 7410","23800","frauenklinik@uke.de",{"type":90,"investigatorFullName":317,"investigatorTitle":318,"investigatorAffiliation":5,"oldNameTitle":55,"oldOrganization":55},"Peter Hillemanns","Prof. Dr. med., Director Department of Gynecology and Obstetrics",[320],{"name":321,"class":6},"German Cancer Aid","100553723",false,"NCT06489795","German-funded Laparoscopic Approach to Cervical Cancer","A Randomized Clinical Trial Comparing Laparoscopic or Robot-assisted Radical\u002FSimple Hysterectomy Versus Abdominal Radical\u002FSimple Hysterectomy in Patients With Early-stage Cervical Cancer","G-LACC","Inclusion Criteria:\n\n1. Histologically confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix\n2. Patients with FIGO stage IA2, IB1, or IB2 disease (\\\u003C4 cm)\n3. Patients undergoing radical hysterectomy according either to Type II or III (Piver Classification) or to Type B or C (Querleu and Morrow classification)\n\n   OR\n\n   Simple hysterectomy can be considered for patients with low-risk early-stage cervical cancer (SHAPE criteria: tumor \\\u003C 2cm, \\\u003C 10 mm depth of stromal invasion (LEEP\u002Fcone). Simple hysterectomy has to be performed as extrafascial hysterectomy and the preparation of a max. 5mm vaginal cuff is required to ensure negative margins.\n4. Performance status of ECOG 0-1\n5. Patient must be suitable candidates for surgery with preoperative MRI and available for assessment of serious adverse events up to one year post-surgery\n6. Patients who have signed an approved Informed Consent\n7. Patients with a prior malignancy only if \\> 5 years previous with no evidence of disease\n8. Females, aged 18 years or older\n\nExclusion Criteria:\n\n1. Any histology other than an adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma of the uterine cervix\n2. Tumor size of 4 cm and greater, estimated by either magnetic resonance imaging (MRI) or clinical examination\n3. FIGO stage IB3 - IV\n4. Patients with a history of pelvic or abdominal radiotherapy\n5. Patients with evidence of metastatic disease by conventional imaging studies, enlarged pelvic or aortic lymph nodes \\> 2 cm, or histologically positive lymph nodes\n6. Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)\n7. Patients unable to withstand prolonged lithotomy and steep Trendelenburg position\n8. Patient compliance and geographic proximity that do not allow adequate follow-up\n9. Women who are pregnant\n10. Patients with contraindications to surgery\n11. Patients with secondary invasive neoplasm in the last 5 years (except non-melanoma skin cancer, breast cancer T1 N0 M0 grade 1 or 2 without any signs of recurrence or activity)","FEMALE","18 Years",{"count":332,"type":333},756,"ESTIMATED","INTERVENTIONAL",[336],"NA","The G-LACC trial is a prospective, interventional, multicenter, open-label, randomized and controlled non-inferiority operative trial.\n\nThe main goal of this clinical trial is to evaluate the non-inferiority of minimally invasive radical hysterectomy in contrast to abdominal radical hysterectomy in patients with early-stage cervical cancer. In the case of SHAPE criteria, surgery may also be performed as minimally invasive or abdominal simple hysterectomy. The primary criterion for assessment is disease-free survival (DFS). As secondary outcomes, overall survival (OS), disease recurrence, quality of life, intra-\u002Fpostoperative complications, and serious adverse events are recorded for assessment.",[339],"Cervical Cancer",[341,342,343,344,345,346],"cervical cancer FIGO stage IA2","cervical cancer FIGO stage IB1","cervical cancer FIGO stage IB2","laparoscopic or robot-assisted radical\u002Fsimple hysterectomy","abdominal radical\u002Fsimple hysterectomy","simple hysterectomy in the case of SHAPE criteria","2025-01-31",{"date":349,"type":350},"2025-02-03","ACTUAL",{"date":352,"type":350},"2024-07-17",{"date":354,"type":333},"2034-01",{"name":5,"class":6},14]