{
  "FullStudy":{
    "Rank":217932,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01514955",
          "OrgStudyIdInfo":{
            "OrgStudyId":"IMRT / 25027"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"ACRI PILOT GRANT"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"AHS Cancer Control Alberta",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"An Initial Feasibility Study to Integrate MRI Based Brachytherapy and CT/MR Fused INRT in Treatment of Advance Cervical Cancer",
          "OfficialTitle":"An Initial Feasibility Study to Integrate High-precision, Image Guided, Radiotherapy(MRI Based Brachytherapy and CT/MRI Fused Dynamic IMRT Planning) in the Treatment Planning of 10 Patients With Locally Advanced Carcinoma of the Cervix",
          "Acronym":"IMRT"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Withdrawn",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"November 2009"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2011",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2011",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"December 8, 2011",
          "StudyFirstSubmitQCDate":"January 18, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 23, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"February 24, 2016",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"February 25, 2016",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"AHS Cancer Control Alberta",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"Cross Cancer Institute",
                "CollaboratorClass":"OTHER"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"Main cause of mortality in cervix cancer is local relapse in the pelvis. Since distant metastasis is quiet rare, increasing local control in the pelvis can directly translate into improvement in survival. Obstacles in front of this approach is the dose limitation to normal organs located in the pelvis adjacent to the tumor. 3-D MRI based EBRT and Brachytherapy will grant safe delivery of more conformal higher doses of radiation to the tumor and allowing sparing of the normal structures.",
          "DetailedDescription":"A total of 10 patients with a diagnosis of locally advanced cervical carcinoma will be enrolled. After diagnosis and written informed consent, patients will undergo investigations prior to treatment planning, including CT imaging as per standard of care. In addition, patients will have an MRI of the pelvis + PET scan + EUA and gold seeds insertion to verify pelvic organs movement and EB-IMRT with daily cone beam CT. Brachytherapy treatment planning will be based on MRI imaging with the applicator in situ."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Integrated MRI Based RT as Standard of Care",
              "Locally Advanced Cervical Cancer"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 1"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Non-Randomized",
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Treatment"
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"0",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Radiation",
                "InterventionName":"Gold seeds insertion to detect movements at pelvis"
              },{
                "InterventionType":"Radiation",
                "InterventionName":"Image guided MRI based RT (IMRT+Brachytherapy)"
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Feasibility parameters",
                "PrimaryOutcomeTimeFrame":"One year"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Response rate, acute and late toxicity, local control rate, survival",
                "SecondaryOutcomeTimeFrame":"Five years"
              },{
                "SecondaryOutcomeMeasure":"Dosimetric comparison between 2D and 3D Brachytherapy treatment planning"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nCancer of the uterine cervix considered suitable for curative treatment with definitive radio-chemo-therapy including MRI guided BT. (stage IB2 bulky disease-stage IVa)\nStaging according to FIGO and TNM guidelines\nPositive biopsy showing squamous cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix\nNo pelvic nodes > 2cm\nMRI of pelvis at diagnosis\nMRI of the retroperitoneal space and abdomen at diagnosis\nMRI with applicator in place at time of BT\nAge 18-70 years\nPatient informed consent\n\nExclusion Criteria:\n\nPelvic nodes > 2cm\nPrevious pelvic or abdominal radiotherapy\nPrevious total or partial hysterectomy\nCombination of preoperative radiotherapy with surgery\nPatients receiving neo-adjuvant chemotherapy\nPatients receiving BT only\nContraindications to MRI",
          "HealthyVolunteers":"No",
          "Gender":"Female",
          "MinimumAge":"18 Years",
          "MaximumAge":"70 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000002583",
                "ConditionMeshTerm":"Uterine Cervical Neoplasms"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000014594",
                "ConditionAncestorTerm":"Uterine Neoplasms"
              },{
                "ConditionAncestorId":"D000005833",
                "ConditionAncestorTerm":"Genital Neoplasms, Female"
              },{
                "ConditionAncestorId":"D000014565",
                "ConditionAncestorTerm":"Urogenital Neoplasms"
              },{
                "ConditionAncestorId":"D000009371",
                "ConditionAncestorTerm":"Neoplasms by Site"
              },{
                "ConditionAncestorId":"D000009369",
                "ConditionAncestorTerm":"Neoplasms"
              },{
                "ConditionAncestorId":"D000002577",
                "ConditionAncestorTerm":"Uterine Cervical Diseases"
              },{
                "ConditionAncestorId":"D000014591",
                "ConditionAncestorTerm":"Uterine Diseases"
              },{
                "ConditionAncestorId":"D000005831",
                "ConditionAncestorTerm":"Genital Diseases, Female"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M4116",
                "ConditionBrowseLeafName":"Carcinoma",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4413",
                "ConditionBrowseLeafName":"Uterine Cervical Neoplasms",
                "ConditionBrowseLeafAsFound":"Cervical Cancer",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M15925",
                "ConditionBrowseLeafName":"Uterine Neoplasms",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M7528",
                "ConditionBrowseLeafName":"Genital Neoplasms, Female",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M15898",
                "ConditionBrowseLeafName":"Urogenital Neoplasms",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4408",
                "ConditionBrowseLeafName":"Uterine Cervical Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M15922",
                "ConditionBrowseLeafName":"Uterine Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M7526",
                "ConditionBrowseLeafName":"Genital Diseases, Female",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC04",
                "ConditionBrowseBranchName":"Cancers and Other Neoplasms"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BXS",
                "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions"
              }
            ]
          }
        }
      }
    }
  }
}