[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100438466":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":45,"responsibleParty":61,"collaborators":25,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":25,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":48,"whyStopped":25,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"The Central and Eastern European Gynecologic Oncology Group","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"A: Surgery only","EXPERIMENTAL","Radical hysterectomy, sentinel lymph node biopsy and systematic pelvic lymphadenectomy (PLND)\\*. No further treatment will be administered.\n\n\\*PLND can be avoided in patients with tumours \\\u003C 4cm",[13],"Radiation: No adjuvant therapy",{"label":15,"type":10,"description":16,"interventionNames":17},"B: Surgery + radiothrerapy","Radical hysterectomy, sentinel lymph node biopsy and systematic pelvic lymphadenectomy (PLND)\\*, followed by adjuvant treatment.\n\n\\*PLND can be avoided in patients with tumours \\\u003C 4cm",[18],"Radiation: Adjuvant radiotherapy",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"RADIATION","No adjuvant therapy","Patients will not receive any type of adjuvant therapy.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Adjuvant radiotherapy","Patients will receive adjuvant treatment composed of either pelvic radiotherapy external beam radiotherapy ± brachytherapy or concomitant chemoradiotherapy (pelvic radiotherapy + chemotherapy).",[15],[31],{"name":32,"affiliation":33,"role":34},"David Cibula, prof.","General University Hospital in Prague, Czech Republic","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Martina Borcinova, PhD","CONTACT","+420224969298","martina.borcinova@cervantes-trial.com",{"name":42,"role":38,"phone":43,"phoneExt":25,"email":44},"Trial Office","+420224967432","trial.office@cervantes-trial.com",[46],{"facility":47,"status":48,"city":49,"state":25,"zip":50,"country":51,"countryCode":25,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"General University Hospital in Prague","RECRUITING","Prague","12000","Czechia",{"type":53,"coordinates":54},"Point",[55,56],14.42076,50.08804,{"lat":56,"lon":55},[59],{"name":60,"role":38,"phone":39,"phoneExt":25,"email":40},"Martina Borcinova",{"type":34,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":64,"oldNameTitle":25,"oldOrganization":25},"David Cibula","prof. David Cibula, MD, PhD","General University Hospital, Prague","100438466","phase-3-intermediate-risk-cervical-cancer-radical-surgery---adjuvant-radiotherapy-100438466",false,"NCT04989647","Intermediate Risk Cervical Cancer: Radical Surgery +\u002F- Adjuvant Radiotherapy","An International Randomised Trial of Radical Surgery Followed by Adjuvant (Chemo)Radiation Versus no Further Treatment in Patients With Early-stage, Intermediate-risk Cervical Cancer Patients","CERVANTES","Inclusion Criteria:\n\n* Pathologically confirmed invasive cervical cancer\n* FIGO IB1-IIA\n* Squamous cell cancer or HPV-related adenocarcinoma\n* Presence of tumour-related risk factors as follows:\n\n  1. tumour ≥4 cm OR\n  2. tumour\\>2 cm \\\u003C4 cm AND lymphovascular space invasion OR\n  3. tumour \\>2 cm \\\u003C4 cm AND tumour free distance \\\u003C3 mm OR\n  4. tumour \\>2 cm \\\u003C4 cm AND deep stromal invasion (\\>2\u002F3)\n* No evidence of suspicious pelvic lymph nodes or distant metastases on imaging (by radiological subjective assessment before surgery and negative pelvic LN on final pathology)\n* ECOG performance status 0-1\n* Deemed suitable and fit for radical surgery followed by adjuvant radiotherapy\n* Negative pregnancy test (if applicable)\n* Negative HIV test (only performed in high-risk countries or patients who have moved from those countries within the past 10 years)\n\nExclusion Criteria:\n\n* Adenosquamous cancer or adenocarcinoma unusual type (non-HPV related - such as: mucinous, clear cell, mesonephric) or other rare tumour types (those not listed in the inclusion criteria)\n* Inconclusive primary site of disease\n* Unequivocally positive lymph node by imaging (by radiological subjective assessment)\n* FIGO \\\u003CIB1 \u002F \\>IIA\n* Previous pelvic malignancy\n* History of second primary cancer outside pelvis if ≤ 3 years complete clinical remission (CCR)\n* Previous pelvic radiotherapy\n* Neoadjuvant chemotherapy prior surgical treatment\n* Low likelihood of patient compliance to the follow-up","FEMALE","18 Years","85 Years",{"count":77,"type":78},514,"ESTIMATED","INTERVENTIONAL",[81],"PHASE3","The objective of the trial is to evaluate if adjuvant (chemo)radiation is associated with a disease-free survival benefit after radical surgery in patients with intermediate risk cervical cancer. The primary endpoint of the study is the disease-free survival from the day of randomisation. A total of 514 patients are required to achieve 80% power on 5% significance level with non-inferiority margin of 5% to test the difference between the ARMs using Cox proportional hazards model. The maximal tolerated margin for non-inferiority in 2-year DFS is 5% (including expected drop-out rate of 10%).",[84],"Cervical Cancer",[86,87,88],"intermediate risk cervical cancer","adjuvant radiotherapy","disease free survival","2023-09-05",{"date":91,"type":92},"2023-09-07","ACTUAL",{"date":94,"type":92},"2022-06-10",{"date":96,"type":78},"2032-12",{"name":5,"class":6},1]