[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100231401":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":37,"locations":47,"responsibleParty":67,"collaborators":31,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":31,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":31,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":50,"whyStopped":31,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Shanghai Jiao Tong University School of Medicine","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"TPF group","EXPERIMENTAL","TPF induction chemotherapy followed with surgery and post-operative radiotherapy docetaxel 75mg\u002Fm2 cisplatin 75 mg\u002Fm2 5-Fu 750 mg\u002Fm2\u002Fday",[13,14,15],"Drug: TPF group","Procedure: surgery group","Radiation: Post-operative radiotherapy",{"label":17,"type":6,"description":18,"interventionNames":19},"surgery group","surgery with post-operative radiotherapy",[14,15],[21,27,32],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","The patients in the experimental group received the TPF induction chemotherapy for 2 cycles followed by radical surgery and post-operative radiotherapy.\n\ndocetaxel:75mg\u002Fm2 cisplatin：75 mg\u002Fm2 5-Fu：750 mg\u002Fm2\u002Fday",[9],[26],"TPF protocol group",{"type":28,"name":17,"description":29,"armGroupLabels":30,"otherNames":31},"PROCEDURE","The patients in the control group received the radical surgery and post-operative radiotherapy.",[9,17],null,{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":31},"RADIATION","Post-operative radiotherapy","Radiotherapy was arranged 4 to 6 weeks after surgery. Routine external beam radiotherapy, such as conformal or intensity modulated radiotherapy was performed, and the dose was 1.8-2 Gy\u002Fday, 5 days\u002Fweek for 6 weeks, and totally 54-60 Gy.",[9,17],[38,43],{"name":39,"role":40,"phone":41,"phoneExt":31,"email":42},"Lai-pimg Zhong, PHD","CONTACT","+86 021-23271699","zhonglaiping@163.com",{"name":44,"role":40,"phone":45,"phoneExt":31,"email":46},"Ying Liu, MPhil","+86 15021196610","alllyliuying@gmail.com",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine","RECRUITING","Shanghai","Shanghai Municipality","200011","China","CN",{"type":57,"coordinates":58},"Point",[59,60],121.45806,31.22222,{"lat":60,"lon":59},[63],{"name":64,"role":40,"phone":65,"phoneExt":66,"email":42},"Lai-ping Zhong, PhD, MD, DDS","+86-21-23271699","5160",{"type":68,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Lai-ping Zhong","Professor,PHD,DDS,MD","100231401","phase-2-cyclin-d1-based-tpf-induction-chemotherapy-for-oral-squamous-cell-carcinoma-patients-at-clinical-n2-stage-100231401",false,"NCT02290145","Cyclin D1 Based TPF Induction Chemotherapy for Oral Squamous Cell Carcinoma Patients at Clinical N2 Stage","Cyclin D1 Based TPF(Docetaxel, Cisplatin and 5-fluorouracil) Induction Chemotherapy for OSCC(Oral Squamous Cell Carcinoma) Patients at cN2(Clinical Node 2) Stage: a Phase II Randomized Controlled Trial","Inclusion Criteria:\n\n* Age: 18 to 75 years old.\n* Sex: both males and females.\n* Karnofsky performance status (KPS) \\>60.\n* Histological biopsy confirming squamous cell carcinoma of the oral cavity (tongue, gingiva, buccal mucosa, floor of mouth, palate, and retromolar region).\n* Cyclin D1 high expression\n* Clinical stage III\u002FIVA (T1-2, N2, M0 or T3-4, N2, M0, UICC\\[International Union Against Cancer\\] 2002) with resectable lesions.\n* Adequate hematologic function: white blood cell \\>3,000\u002Fmm3, hemoglobin\\>8g\u002FL, platelet count\\>80,000\u002Fmm3.\n* Hepatic function: ALAT(alanine aminotransferase)\u002FASAT(aspartate transaminase) \\\u003C2.5 times the upper limit of normal (ULN), bilirubin \\\u003C1.5 times ULN.\n* Renal function: serum creatinine \\\u003C1.5 times ULN.\n* Written informed consent\n\nExclusion Criteria:\n\n* Evidence of distant metastatic disease and other cancers.\n* Surgical procedure of the primary tumors or lymph nodes (except diagnostic biopsy).\n* Previous radiotherapy or chemotherapy.\n* Other previous malignancies within 5 years.\n* Can not tolerate the treatment protocol with systematic diseases such as history of severe pulmonary or cardiac diseases.\n* Legal incapacity or limited legal capacity.\n* Creatinine clearance \\\u003C30ml\u002Fmin.\n* Pregnancy (confirmed by serum or urine β-HCG) or lactation period.","ALL","18 Years","75 Years",{"count":82,"type":83},48,"ESTIMATED","INTERVENTIONAL",[86],"PHASE2","The purpose of this study is to To confirm the predictive value of CCND1 for TPF induction in cN2 patients with OSCC",[89,90],"Mouth Neoplasms","Carcinoma, Squamous Cell",[92],"docetaxel, cisplatin, 5-FU, cyclinD1","2023-11-21",{"date":95,"type":96},"2023-11-22","ACTUAL",{"date":98,"type":31},"2016-12",{"date":100,"type":83},"2026-12",{"name":5,"class":6},1]