[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509438":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":46,"responsibleParty":63,"collaborators":44,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":44,"enrollmentInfo":75,"targetDuration":44,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":44,"overallStatus":48,"whyStopped":44,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"EDP-M plus MEGESTROL ACETATE 160 mg","EXPERIMENTAL","EDP will be administered at the following doses: doxorubicin 40 mg\u002Fm2 on day 1, etoposide 100 mg\u002Fm2 days 2-4, cisplatin 40 mg\u002Fm2 days 3-4, every 28 days. Concomitant mitotane therapy will be administered continuously. Megestrole 160 mg 2 tablets will be administered once daily (in the morning) and will be stopped 21 days after the last administration of the EDP.",[13],"Drug: Etoposide, doxorubicin, cisplatin and Mitotane plus Megestrol Acetate 160 MG",{"label":15,"type":16,"description":17,"interventionNames":18},"EDP-M plus PLACEBO","PLACEBO_COMPARATOR","EDP will be administered at the following doses: doxorubicin 40 mg\u002Fm2 on day 1, etoposide 100 mg\u002Fm2 days 2-4, cisplatin 40 mg\u002Fm2 days 3-4, every 28 days. Concomitant mitotane therapy will be administered continuously. Placebo 2 tablets will be administered once daily (in the morning) and will be stopped 21 days after the last administration of the EDP.",[19],"Drug: Etoposide, doxorubicin, cisplatin and Mitotane plus Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Etoposide, doxorubicin, cisplatin and Mitotane plus Megestrol Acetate 160 MG","EDP will be administered at the following doses: doxorubicin 40 mg\u002Fm2 on day 1, etoposide 100 mg\u002Fm2 days 2-4, cisplatin 40 mg\u002Fm2 days 3-4, every 28 days.\n\nMegestrol acetate will be prepared and packaged by the authorized external contract development and manufacturing organization (CDMO) Doppel Farmaceutici s.r.l. (Cortemaggiore, PC), that, according to the GMP and applicable law (FU XII ed) will also prepare the related placebo, in accordance with GMP (annex 13) and applicable law (FU XII ed.).",[9],[27],"Megace",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Etoposide, doxorubicin, cisplatin and Mitotane plus Placebo","EDP will be administered at the following doses: doxorubicin 40 mg\u002Fm2 on day 1, etoposide 100 mg\u002Fm2 days 2-4, cisplatin 40 mg\u002Fm2 days 3-4, every 28 days. Placebo 160 mg tablets will be developed by the CDMO to have the same appearance and taste as the tablet containing the active drug.",[15],[33],"placebo",[35],{"name":36,"affiliation":37,"role":38},"Alfredo Berruti","Asst Degli Spedali Civili Di Brescia","PRINCIPAL_INVESTIGATOR",[40],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Aldo Roccaro","CONTACT","+390303996851",null,"coordinamento.ricerca@asst-spedalicivili.it",[47],{"facility":36,"status":48,"city":49,"state":44,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","Brescia","25123","Italy","IT",{"type":54,"coordinates":55},"Point",[56,57],10.21472,45.53558,{"lat":57,"lon":56},[60],{"name":36,"role":42,"phone":61,"phoneExt":44,"email":62},"+390303995260","alfredo.berruti@gmail.com",{"type":38,"investigatorFullName":36,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"Medical Oncologist","100509438","phase-2-evaluation-of-the-efficacy-of-addition-of-progesterone-to-standard-chemotherapy-in-adrenocortical-carcinoma-acc-100509438",false,"NCT05913427","Evaluation of the Efficacy of Addition of Progesterone to Standard Chemotherapy in Adrenocortical Carcinoma (ACC)","Prospective, Phase II Study to Evaluate the Efficacy of Addition of Progesterone to Standard Chemotherapy According to Etoposide-Doxorubicin-Cisplatin Scheme Plus Mitotane (EDP-M) in Patients With Advanced Adrenocortical Carcinoma (ACC)","PESETA","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of ACC\n* Locally advanced or metastatic disease not amenable to radical surgery resection\n* ECOG performance status 0-2\n* Effective contraception\n* Life expectancy \\> 3 months\n* Age \\> 18 years\n* Adequate bone marrow reserve (neutrophils \\>1,000\u002Fmm3 and\u002For platelets \\>80,000\u002Fmm3) and organ function (including renal, liver and cardiac function)\n* Be able to comply with the protocol procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* History of recent or active prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, breast ductal carcinoma in situ, or other treated malignancies where there has been no evidence of disease for at least 2 years\n* Renal insufficiency (estimated glomerular filtration rate \\[GFR\\]\\\u003C50 mL\u002Fmin\u002F1.73 m2) or significant liver insufficiency (serum bilirubin\\>2 times the upper normal range and\u002For serum alanine aminotransferase \\[ALT\\] or aspartate aminotransferase \\[AST\\]\\>3 times the upper normal range). GFRs will be calculated according to the validated formula (MDRD)\n* Pregnancy or breast feeding\n* Congestive heart failure (ejection fraction\\\u003C45%)\n* Preexisting grade 2 peripheral neuropathy\n* Previous or current treatment with mitotane or other antineoplastic drugs for ACC\n* Previous radiotherapy for ACC\n* Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration or that, in the judgment of the investigator, would make the patient inappropriate for entry into this study.","ALL","18 Years",{"count":76,"type":77},80,"ESTIMATED","INTERVENTIONAL",[80],"PHASE2","This is a prospective randomized, double blind, placebo controlled phase II study planned in patients with advanced ACC. The study will be conducted at ASST Spedali Civili Hospital and University of Brescia in Brescia.",[83],"Adrenocortical Carcinoma","2024-07-31",{"date":86,"type":87},"2024-08-01","ACTUAL",{"date":89,"type":87},"2022-06-08",{"date":91,"type":77},"2027-06-08",{"name":5,"class":6},1]