{ "FullStudy":{ "Rank":217775, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01516996", "OrgStudyIdInfo":{ "OrgStudyId":"BT-IST-SCCHN-036" }, "Organization":{ "OrgFullName":"The Second People's Hospital of Sichuan", "OrgClass":"OTHER" }, "BriefTitle":"Safety and Efficacy Study of Nimotuzumab Plus Neoadjuvant and Concurrent Chemoradiotherapy to Treat Oropharynx and Hypopharynx Cancer", "OfficialTitle":"Neoadjuvant and Concurrent Chemoradiotherapy Plus Nimotuzumab in Treating Patients With Locoregionally Advanced Squamous Cell Carcinoma of the Oropharynx and Hypopharynx" }, "StatusModule":{ "StatusVerifiedDate":"March 2012", "OverallStatus":"Unknown status", "LastKnownStatus":"Recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"March 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"September 2013", "PrimaryCompletionDateType":"Anticipated" }, "CompletionDateStruct":{ "CompletionDate":"March 2018", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 11, 2012", "StudyFirstSubmitQCDate":"January 20, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"March 18, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"March 20, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"LANG Jin-yi", "ResponsiblePartyInvestigatorTitle":"Professor of radiotherapy department", "ResponsiblePartyInvestigatorAffiliation":"The Second People's Hospital of Sichuan" }, "LeadSponsor":{ "LeadSponsorName":"The Second People's Hospital of Sichuan", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Biotech Pharmaceutical Co., Ltd.", "CollaboratorClass":"OTHER" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to evaluate the efficiency and safety of adding nimotuzumab to neoadjuvant and concurrent chemoradiotherapy in the treatment of patients with locoregionally advanced squamous cell carcinoma of the oropharynx and hypopharynx.", "DetailedDescription":"Locoregionally advanced squamous cell carcinoma of the head and neck(LA-SCCHN) poses one of the most complex management challenges. This stage of disease is still potentially curable, but requires combined-modality therapy. Recent studies have showed that induction chemotherapy（neoadjuvant）reduced the 3-year distant relapse rate. Concurrent chemoradiotherapy(CCRT), on the other hand, has demonstrated a significant and consistent benefit in local control rates, but its impact on distant failure is inconsistent. Nimotuzumab is a novel EGFR-targeting monoclonal antibody that has the potential.to be used as a single agent or as a radio- and chemotherapy sensitizer for the treatment of SCCHN. Thus, investigators conducted a randomized, multicenter phaseⅡ study to compare the efficiency and safety of adding nimotuzumab to neoadjuvant and CCRT with neoadjuvant and CCRT in the treatment of patients with locoregionally advanced squamous cell carcinoma of the oropharynx and hypopharynx." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Oropharyngeal Cancer", "Hypopharyngeal Cancer" ] }, "KeywordList":{ "Keyword":[ "Neoadjuvant", "Concurrent Chemoradiotherapy,CCRT", "Nimotuzumab", "Locoregionally Advanced Oropharynx", "Hypopharynx cancer", "Randomized", "Multicenter" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"80", "EnrollmentType":"Anticipated" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Neoadjuvant and CCRT", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: docetaxel and cisplatin", "Radiation: IMRT" ] } },{ "ArmGroupLabel":"Neoadjuvant and CCRT and Nimotuzumab", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: docetaxel and cisplatin", "Radiation: IMRT", "Biological: Nimotuzumab" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"docetaxel and cisplatin", "InterventionDescription":"The neoadjuvant consists of docetaxel 75mg/m2 day 1 and cisplatin 75mg/m2 days 1 to 3, repeat every 3 weeks, for 2 cycles.\nCCRT: cisplatin 75mg/m2 is administered on day 1 of week 7,10 and 13 on current with RT", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Neoadjuvant and CCRT", "Neoadjuvant and CCRT and Nimotuzumab" ] } },{ "InterventionType":"Radiation", "InterventionName":"IMRT", "InterventionDescription":"IMRT is administered with chemotherapy from week 7 to week 13\n\nGTV（primary tumor）：68-70Gy/35~38 F，once a day, 5 times per week\nCTV（Clinical target）：56-66Gy/30~36f，once a day, 5 times per week\nGTV-ln（positive neck region）：66-70Gy/33~36 F，once a day, 5 times per week\nCTV-ln（negative neck region）：50-54Gy/28~30F, once a day, 5 times", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Neoadjuvant and CCRT", "Neoadjuvant and CCRT and Nimotuzumab" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "CCRT" ] } },{ "InterventionType":"Biological", "InterventionName":"Nimotuzumab", "InterventionDescription":"Nimotuzumab was administered 200 mg IV over 1 hour on day 1,once a week, for 13~14 weeks", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Neoadjuvant and CCRT and Nimotuzumab" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Objective response rate", "PrimaryOutcomeDescription":"Objective Response Rate: Complete response (CR)+ partial response (PR) rates base on RECIST evaluation system.", "PrimaryOutcomeTimeFrame":"3 months after all the treatment ending" },{ "PrimaryOutcomeMeasure":"The Number of Participants with Adverse Events", "PrimaryOutcomeDescription":"Record the Number of participants with adverse events and the Grades of the AE according to CTCAE v3.0 as the two measure of safety.", "PrimaryOutcomeTimeFrame":"Participants will be followed during the treatment and 3 months after all the treatment ending ,an expected average of 26 weeks" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Overall Survival", "SecondaryOutcomeTimeFrame":"From date of randomization until the date of death from any cause,assessed up to 5 years" },{ "SecondaryOutcomeMeasure":"Progression-Free Survival", "SecondaryOutcomeTimeFrame":"From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years" },{ "SecondaryOutcomeMeasure":"Evaluate the Local control Rate in 1 to 5 years.", "SecondaryOutcomeDescription":"To evaluate each year until 5 years later", "SecondaryOutcomeTimeFrame":"Participants will be followed every year for the duration of 5 years" },{ "SecondaryOutcomeMeasure":"Tumor-Free Survival", "SecondaryOutcomeTimeFrame":"From date of randomization until the date of first documented occurrence of primary, neck, distant relapse,assessed up to 5 years" },{ "SecondaryOutcomeMeasure":"Non-metastatic Rate", "SecondaryOutcomeTimeFrame":"The time from randomization until distant relapse occur,assessed up to 5 years" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nInformed consent form\nHistologically confirmed locally advanced (stages III and IVb), squamous cell carcinoma of the oropharynx and hypopharynx\nThe tumor mass had to be measurable\nKarnofsky performance status ≥70\nLife expectancy estimated than 6 months\nHematologic: WBC≥4×109 /L , plateletes≥100×109 /L, haemoglobin ≥100 g/L；\nHepatic: AST/ALT＜1.5 times upper limit of normal (ULN)；serum bilirubin<1.5 times ULN;\nRenal: Creatinine＜1.5 times ULN；\n\nExclusion Criteria:\n\nKnown distant metastases\nPrimary tumor and nodes received surgery(except of biopsy)\nReceived other anti EGFR monoclonal antibody treatment\nPrevious chemotherapy or radiotherapy\nParticipation in other interventional clinical trials within 1 month\nOther malignant tumor (except of non-melanoma skin Cancer or carcinoma in situ of cervix)\nHistory of serious allergic or allergy\nHistory of Serious lung or heart disease\nPregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"70 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Yi J Lang, M.D.", "OverallOfficialAffiliation":"Radiotherapy department", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Gansu Province Medical Science Institute", "LocationStatus":"Active, not recruiting", "LocationCity":"Lanzhou", "LocationState":"Gansu", "LocationZip":"730050", "LocationCountry":"China" },{ "LocationFacility":"Guangxi Tumor Hospital", "LocationStatus":"Active, not recruiting", "LocationCity":"Nanning", "LocationState":"Guangxi", "LocationZip":"530021", "LocationCountry":"China" },{ "LocationFacility":"GuiZhou Cancer Hospital", "LocationStatus":"Active, not recruiting", "LocationCity":"Guiyang", "LocationState":"Guizhou", "LocationZip":"550004", "LocationCountry":"China" },{ "LocationFacility":"Neimenggu Tumor Hospital", "LocationStatus":"Active, not recruiting", "LocationCity":"Baotou", "LocationState":"Neimenggu", "LocationZip":"014030", "LocationCountry":"China" },{ "LocationFacility":"The Tumor Affiliated Hospital of Ningxia Medical University General Hospita", "LocationStatus":"Active, not recruiting", "LocationCity":"Yinchuan", "LocationState":"Ningxia", "LocationZip":"750004", "LocationCountry":"China" },{ "LocationFacility":"Qinghai Five Hospital", "LocationStatus":"Active, not recruiting", "LocationCity":"Xining", "LocationState":"Qinghai", "LocationCountry":"China" },{ "LocationFacility":"Xijing Hospital", "LocationStatus":"Active, not recruiting", "LocationCity":"Xi-an", "LocationState":"Shanxi", "LocationZip":"710032", "LocationCountry":"China" },{ "LocationFacility":"ShanXi Cancer Hospital", "LocationStatus":"Active, not recruiting", "LocationCity":"Xian", "LocationState":"Shanxi", "LocationZip":"710061", "LocationCountry":"China" },{ "LocationFacility":"The Second People's Hospital of Sichuan", "LocationStatus":"Recruiting", "LocationCity":"Chengdu", "LocationState":"Sichuan", "LocationZip":"610041", "LocationCountry":"China", "LocationContactList":{ "LocationContact":[ { "LocationContactName":"Peng Xu, M.D.", "LocationContactRole":"Contact", "LocationContactPhone":"15828312322", "LocationContactEMail":"xupeng4618@163.com" } ] } },{ "LocationFacility":"West China Hospital, Sichuan University", "LocationStatus":"Active, not recruiting", "LocationCity":"Chengdu", "LocationState":"Sichuan", "LocationZip":"610041", "LocationCountry":"China" },{ "LocationFacility":"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University", "LocationStatus":"Active, not recruiting", "LocationCity":"Chongqing", "LocationState":"Sichuan", "LocationZip":"400042", "LocationCountry":"China" },{ "LocationFacility":"Xinjiang tumor hospital, The Third Affiliated Hospital of Xinjiang Medical University", "LocationStatus":"Active, not recruiting", "LocationCity":"Wulumuqi", "LocationState":"Xinjiang", "LocationZip":"830000", "LocationCountry":"China" },{ "LocationFacility":"Yunnan Tumor Hospital, The Third Affiliated Hospital of KUNMING Medical University", "LocationStatus":"Active, not recruiting", "LocationCity":"Kunming", "LocationState":"Yunnan", "LocationZip":"652100", "LocationCountry":"China" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000077143", "InterventionMeshTerm":"Docetaxel" },{ "InterventionMeshId":"C000501466", "InterventionMeshTerm":"Nimotuzumab" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000970", "InterventionAncestorTerm":"Antineoplastic Agents" },{ "InterventionAncestorId":"D000050257", "InterventionAncestorTerm":"Tubulin Modulators" },{ "InterventionAncestorId":"D000050256", "InterventionAncestorTerm":"Antimitotic Agents" },{ "InterventionAncestorId":"D000050258", "InterventionAncestorTerm":"Mitosis Modulators" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" },{ "InterventionAncestorId":"D000074322", "InterventionAncestorTerm":"Antineoplastic Agents, Immunological" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M1668", "InterventionBrowseLeafName":"Docetaxel", "InterventionBrowseLeafAsFound":"Docetaxel", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M4765", "InterventionBrowseLeafName":"Cisplatin", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M269888", "InterventionBrowseLeafName":"Nimotuzumab", "InterventionBrowseLeafAsFound":"Nimotuzumab", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M24784", "InterventionBrowseLeafName":"Tubulin Modulators", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M24783", "InterventionBrowseLeafName":"Antimitotic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M1346", "InterventionBrowseLeafName":"Antineoplastic Agents, Immunological", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"ANeo", "InterventionBrowseBranchName":"Antineoplastic Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000009959", "ConditionMeshTerm":"Oropharyngeal Neoplasms" },{ "ConditionMeshId":"D000007012", "ConditionMeshTerm":"Hypopharyngeal Neoplasms" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000010610", "ConditionAncestorTerm":"Pharyngeal Neoplasms" },{ "ConditionAncestorId":"D000010039", "ConditionAncestorTerm":"Otorhinolaryngologic Neoplasms" },{ "ConditionAncestorId":"D000006258", "ConditionAncestorTerm":"Head and Neck Neoplasms" },{ "ConditionAncestorId":"D000009371", "ConditionAncestorTerm":"Neoplasms by Site" },{ "ConditionAncestorId":"D000009369", "ConditionAncestorTerm":"Neoplasms" },{ "ConditionAncestorId":"D000010608", "ConditionAncestorTerm":"Pharyngeal Diseases" },{ "ConditionAncestorId":"D000009057", "ConditionAncestorTerm":"Stomatognathic Diseases" },{ "ConditionAncestorId":"D000010038", "ConditionAncestorTerm":"Otorhinolaryngologic Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M4116", "ConditionBrowseLeafName":"Carcinoma", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4132", "ConditionBrowseLeafName":"Carcinoma, Squamous Cell", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M11468", "ConditionBrowseLeafName":"Oropharyngeal Neoplasms", "ConditionBrowseLeafAsFound":"Oropharyngeal Cancer", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M8645", "ConditionBrowseLeafName":"Hypopharyngeal Neoplasms", "ConditionBrowseLeafAsFound":"Hypopharyngeal cancer", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M12100", "ConditionBrowseLeafName":"Pharyngeal Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M11545", "ConditionBrowseLeafName":"Otorhinolaryngologic Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7931", "ConditionBrowseLeafName":"Head and Neck Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M12098", "ConditionBrowseLeafName":"Pharyngeal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10600", "ConditionBrowseLeafName":"Stomatognathic Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M11544", "ConditionBrowseLeafName":"Otorhinolaryngologic Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T2963", "ConditionBrowseLeafName":"Hypopharyngeal Cancer", "ConditionBrowseLeafAsFound":"Hypopharyngeal cancer", "ConditionBrowseLeafRelevance":"high" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC04", "ConditionBrowseBranchName":"Cancers and Other Neoplasms" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC07", "ConditionBrowseBranchName":"Mouth and Tooth Diseases" },{ "ConditionBrowseBranchAbbrev":"BC09", "ConditionBrowseBranchName":"Ear, Nose, and Throat Diseases" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }