{
  "FullStudy":{
    "Rank":217938,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01514877",
          "OrgStudyIdInfo":{
            "OrgStudyId":"ZhejiangCH-LCBM-1201"
          },
          "Organization":{
            "OrgFullName":"Zhejiang Cancer Hospital",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Icotinib Combined With Whole Brain Radiotherapy in Treating Multiple Brain Metastases From Non-Small Cell Lung Cancer",
          "OfficialTitle":"Phase II Study of Icotinib Combined With Whole Brain Radiotherapy in Treating Patients With Brain Metastases From Non-Small Cell Lung Cancer"
        },
        "StatusModule":{
          "StatusVerifiedDate":"July 2014",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"July 2014",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"July 2014",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 17, 2012",
          "StudyFirstSubmitQCDate":"January 20, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 23, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"July 22, 2014",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"July 23, 2014",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Zhejiang Cancer Hospital",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The aim of this study is to explore the efficacy and toxicity of icotinib combined with WBRT in treating patients with multiple brain metastases from NSCLC.",
          "DetailedDescription":"Brain metastases occur in 25-40% of patients with non-small cell lung cancer (NSCLC). It is one of the primary reasons resulting in treatment failure and the death. Whole-brain radiation therapy (WBRT) is the standard approach to the treatment of multiple brain metastases from NSCLC. Regardless of the treatment of brain metastases by WBRT combined with systemic chemotherapy,outcomes of NSCLC with brain metastases are still very poor. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) can pass through the blood-brain barrier and show promising antitumor activity against brain metastases from NSCLC. Icotinib shows nearly the same effect as gefitinib in advanced NSCLC patients failed with chemotherapy."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Lung Cancer",
              "Metastatic Cancer"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "tumors metastatic to brain",
              "non-small cell lung cancer",
              "Icotinib"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 2"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"20",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Icotinib plus Whole Brain Radiotherapy",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs), such as gefitinib and erlotinib, have shown efficacy in advanced non-small cell lung cancer (NSCLC) patients with brain metastases (BM). Icotinib is a new first generation EGFR-TKI. We conducted a phase II study to evaluate the efficacy and safety of icotinib in combination with whole brain radiotherapy （WBRT） in Chinese NSCLC patients with BM and investigated the cerebrospinal fluid (CSF)/ plasma concentrations of icotinib.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Icotinib"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Icotinib",
                "InterventionDescription":"Patients will receive whole brain radiotherapy therapy 30Gy over 10 fractions and icotinib will be administered at the beginning of whole brain radiotherapy in doses of 125 mg thrice per day until disease progression or undue toxicity.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Icotinib plus Whole Brain Radiotherapy"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"partial response rate of intracranial lesions",
                "PrimaryOutcomeDescription":"Partial response rate of intracranial lesions will be measured.",
                "PrimaryOutcomeTimeFrame":"2 years"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Progression-free survival",
                "SecondaryOutcomeDescription":"Progression-free survival will be evaluated",
                "SecondaryOutcomeTimeFrame":"4 years"
              },{
                "SecondaryOutcomeMeasure":"overall survival",
                "SecondaryOutcomeDescription":"Overall survival will be evaluated",
                "SecondaryOutcomeTimeFrame":"4 years"
              },{
                "SecondaryOutcomeMeasure":"partial response rate of extracranial lesions",
                "SecondaryOutcomeDescription":"Partial response rate of extracranial lesions will be evaluated",
                "SecondaryOutcomeTimeFrame":"2 years"
              },{
                "SecondaryOutcomeMeasure":"Health-related quality of life",
                "SecondaryOutcomeDescription":"Health-related quality of life will be measured",
                "SecondaryOutcomeTimeFrame":"2 years"
              },{
                "SecondaryOutcomeMeasure":"safety and tolerability",
                "SecondaryOutcomeDescription":"Safety and tolerability of Icotinib and whole brain radiotherapy will be monitored by evaluation of frequency,severity,and duration of treatment-emergent adverse events in all subjects",
                "SecondaryOutcomeTimeFrame":"4 year"
              },{
                "SecondaryOutcomeMeasure":"the relationship between Progression-Free Survival and EGFR mutation status",
                "SecondaryOutcomeDescription":"The relationship between Progression-Free Survival and EGFR mutation status will be evaluated.",
                "SecondaryOutcomeTimeFrame":"4 years"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nCytologic or histological diagnosis of non-small cell lung cancer\nPatients with disease progression after systemic chemotherapy with two-drug combination regimens that includes a platinum agent or patients with EGFR mutation status who have not been treated\nPatients are diagnosed with multiple brain metastases for the first time in 4 weeks\nDiagnosis of brain metastases is made based on Magnetic resonance imaging (MRI).\nDoctors consider the patient will benefit from WBRT\nNo prior brain radiotherapy\nECOG performance status 0-2\nage:18-75 years\nNeutrophil count ≥1.5×10 to the 9th power/L and platelets≥100×10 to the 9th power/L. hemoglobin ≥90 g/L\nHepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN) Alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN (or less than or equal to 5 times ULN in case of known liver involvement)\nRenal: Serum Creatinine less than or equal to 1.5 times upper limit of normal (ULN)\nPatients with measurable brain metastases according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria\nPatients must sign an informed consent indicating that they are aware of the investigational nature of the study\n\nExclusion Criteria:\n\nPrior brain radiation therapy\nSolitary brain metastasis according to Magnetic resonance imaging (MRI)\nMort than 3 extracranial organs have metastatic lesions\nPrior invasive malignancy (skin basal cell cancer, carcinoma in situ of cervix are permissible).\npregnant or breast feeding women",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"75 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Yun Fan, MD",
                "OverallOfficialAffiliation":"Zhejiang Cancer Hospital",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Zhejiang Cancer Hospital",
                "LocationCity":"Hangzhou",
                "LocationState":"Zhejiang",
                "LocationZip":"310022",
                "LocationCountry":"China"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"26148750",
                "ReferenceType":"derived",
                "ReferenceCitation":"Fan Y, Huang Z, Fang L, Miao L, Gong L, Yu H, Yang H, Lei T, Mao W. A phase II study of icotinib and whole-brain radiotherapy in Chinese patients with brain metastases from non-small cell lung cancer. Cancer Chemother Pharmacol. 2015 Sep;76(3):517-23. doi: 10.1007/s00280-015-2760-5. Epub 2015 Jul 7."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000008175",
                "ConditionMeshTerm":"Lung Neoplasms"
              },{
                "ConditionMeshId":"D000002289",
                "ConditionMeshTerm":"Carcinoma, Non-Small-Cell Lung"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000012142",
                "ConditionAncestorTerm":"Respiratory Tract Neoplasms"
              },{
                "ConditionAncestorId":"D000013899",
                "ConditionAncestorTerm":"Thoracic Neoplasms"
              },{
                "ConditionAncestorId":"D000009371",
                "ConditionAncestorTerm":"Neoplasms by Site"
              },{
                "ConditionAncestorId":"D000009369",
                "ConditionAncestorTerm":"Neoplasms"
              },{
                "ConditionAncestorId":"D000008171",
                "ConditionAncestorTerm":"Lung Diseases"
              },{
                "ConditionAncestorId":"D000012140",
                "ConditionAncestorTerm":"Respiratory Tract Diseases"
              },{
                "ConditionAncestorId":"D000002283",
                "ConditionAncestorTerm":"Carcinoma, Bronchogenic"
              },{
                "ConditionAncestorId":"D000001984",
                "ConditionAncestorTerm":"Bronchial Neoplasms"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M10890",
                "ConditionBrowseLeafName":"Neoplasm Metastasis",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M9755",
                "ConditionBrowseLeafName":"Lung Neoplasms",
                "ConditionBrowseLeafAsFound":"Lung Cancer",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M4128",
                "ConditionBrowseLeafName":"Carcinoma, Non-Small-Cell Lung",
                "ConditionBrowseLeafAsFound":"Non-Small Cell Lung Cancer",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M4116",
                "ConditionBrowseLeafName":"Carcinoma",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13562",
                "ConditionBrowseLeafName":"Respiratory Tract Neoplasms",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M15241",
                "ConditionBrowseLeafName":"Thoracic Neoplasms",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M9751",
                "ConditionBrowseLeafName":"Lung Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13560",
                "ConditionBrowseLeafName":"Respiratory Tract Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4122",
                "ConditionBrowseLeafName":"Carcinoma, Bronchogenic",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3842",
                "ConditionBrowseLeafName":"Bronchial Neoplasms",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC04",
                "ConditionBrowseBranchName":"Cancers and Other Neoplasms"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC08",
                "ConditionBrowseBranchName":"Respiratory Tract (Lung and Bronchial) Diseases"
              }
            ]
          }
        }
      }
    }
  }
}