[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100200576":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":39,"locations":49,"responsibleParty":66,"collaborators":26,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":26,"enrollmentInfo":78,"targetDuration":26,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":26,"overallStatus":52,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Gustave Roussy, Cancer Campus, Grand Paris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1","EXPERIMENTAL","* PET-TDM\n* carboplatine: Dose (mg) = AUC x (GFR + 25)\n\n  * GFR : glomérulaire filtration (ml\u002Fmin)\n  * AUC : area under curve (mg\u002Fml x min)",[13],"Drug: Carboplatin",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2","* PET-TDM\n* ETOPOSIDE (100 mg\u002Fm2 D1 to D5) and CISPLATINE (20 mg\u002Fm2 de D1 to D5)\n* carboplatine: Dose (mg) = AUC x (GFR + 25)\n\n  * GFR : glomérulaire filtration (ml\u002Fmin)\n  * AUC : area under curve (mg\u002Fml x min)",[13,18,19],"Drug: Etoposide","Drug: Cisplatin",[21,27,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Carboplatin","\\- carboplatine: Dose (mg) = AUC x (GFR + 25)\n\n* GFR : glomérulaire filtration (ml\u002Fmin)\n* AUC : area under curve (mg\u002Fml x min)",[9,15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Etoposide","100 mg\u002Fm2 D1 to D5",[15],{"type":22,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"Cisplatin","20 mg\u002Fm2 de D1 to D5",[15],[36],{"name":37,"affiliation":5,"role":38},"Yohann LORIOT, MD","STUDY_CHAIR",[40,45],{"name":37,"role":41,"phone":42,"phoneExt":43,"email":44},"CONTACT","0142115276","+33","yohann.loriot@gustaveroussy.fr",{"name":46,"role":41,"phone":47,"phoneExt":43,"email":48},"Emilie LANOY","0142114121","emilie.lannoy@gustaveroussy.fr",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Gustave Roussy","RECRUITING","Villejuif","Val de Marne","94805","France","FR",{"type":59,"coordinates":60},"Point",[61,62],2.35992,48.7939,{"lat":62,"lon":61},[65],{"name":37,"role":41,"phone":42,"phoneExt":43,"email":44},{"type":67,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100200576","phase-2-therapeutic-strategy-guided-by-pet-tdm-for-patients-with-seminoma-100200576",false,"NCT01887340","Therapeutic Strategy Guided by PET-TDM for Patients With Seminoma","Therapeutic Strategy Guided by PET-TDM for Patients With Grade I or Metastatic Seminoma","SEMITEP","Inclusion Criteria shared:\n\n* Histologically proved seminoma after orchiectomy\n* Primary testicular or retroperitoneal\n* Normal alpha-fetoprotein before and after orchiectomy\n* No prior treatment with radiotherapy or chemotherapy\n* Age \\>= 18 years\n* ECOG 0 to 2\n* PNN \\>= 1500, platelets \\>= 100 000, bilirubin \\\u003C= the upper limit nromale\n* ASAT (SGOT) and ALAT (SGPT) \\\u003C= 1,5 x the upper limit nromale\n* Serum creatinine \\\u003C140 µmol \u002F L (or clearance\\> 60 mL \u002F min)\n* Information and signed informed consent before inclusion in the study\n* Patient affiliated to a social security\n\nSpecific inclusion criteria for cohort 1:\n\n* grade I\n\nSpecific inclusion criteria for cohort 2:\n\n* grade IIB (retroperitoneal adenopathy diameter between 2 cm and 5 cm, regardless of the LDH)\n* grade IIC (retroperitoneal adenopathy diameter higher than 5 cm, regardless of the LDH)\n* grade III of good prognosis (supradiaphragmatic reach with ganglionic metastasis and LDH \\\u003C 2 times normal limit and\u002For supradiaphragmatic reach with pulmonary metastasis and LDH \\\u003C 2 times normal limit) either at initial diagnosis or relapse of a grade I seminoma)\n* PET-TDM positive (pathological fixation on metastatic lesions)\n\nExclusion Criteria shared:\n\n* Patient infected by HIV, Hepatitis B or C\n* History, within 5 years, of cancer other than seminoma, except for treated skin cancer (Basal Cell) .\n* visceral metastasis\n* cerebral metastasis\n* Any physical or mental condition incompatible with the treatment (to the investigator discretion)\n* Uncontrolled or severe cardiovascular pathology\n* Uncontrolled or severe hepatic pathology\n* Persons deprived of liberty or under guardianship\n* Unable to undergo medical monitoring due to geographical, social or psychological reasons","MALE","18 Years",{"count":79,"type":80},271,"ESTIMATED","INTERVENTIONAL",[83],"PHASE2","The purpose of the study is to evaluate the ration of patients getting an lighten therapeutic strategy after 18F-fluoro-désoxyglucose positron emission tomography (PET-TDM) in grade I (cohort 1) or metastatic (cohort 2) seminoma",[86],"Seminoma","2016-06-08",{"date":89,"type":80},"2016-06-09",{"date":91,"type":26},"2013-06",{"date":93,"type":80},"2026-06",{"name":5,"class":6},1]