{ "FullStudy":{ "Rank":217555, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01519869", "OrgStudyIdInfo":{ "OrgStudyId":"11-GYN-098-MCC" }, "Organization":{ "OrgFullName":"University of Kentucky", "OrgClass":"OTHER" }, "BriefTitle":"Trial of Chemotherapy in Ovarian, Fallopian Tube and Peritoneal Carcinoma", "OfficialTitle":"Neoadjuvant Platinum-based Chemotherapy in Advanced Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma Trial Protocol" }, "StatusModule":{ "StatusVerifiedDate":"February 2020", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"March 2012", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"October 11, 2019", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"October 11, 2019", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 18, 2012", "StudyFirstSubmitQCDate":"January 26, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 27, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"February 24, 2020", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"February 26, 2020", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor-Investigator", "ResponsiblePartyInvestigatorFullName":"Rachel Miller", "ResponsiblePartyInvestigatorTitle":"Assistant Professor, Obstetrics and Gynecology", "ResponsiblePartyInvestigatorAffiliation":"University of Kentucky" }, "LeadSponsor":{ "LeadSponsorName":"Rachel Miller", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"Yes", "IsFDARegulatedDrug":"Yes", "IsFDARegulatedDevice":"No" }, "DescriptionModule":{ "BriefSummary":"This is a prospective study to evaluate the hypothesis that platinum-based neoadjuvant chemotherapy followed by interval surgical debulking with platinum-based adjuvant chemotherapy is associated with improved maximal surgical cytoreduction rates, comparable survival, decreased morbidity, and increased quality of life in patients with International Federation of Gynecologic Oncology stages IIIC and IV ovarian, primary peritoneal, or fallopian tube cancer when compared to historical controls and to evaluate the hypothesis that cancer induced inflammation is a predictor of poor prognosis and response to therapy in this group of ovarian cancer patients." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Primary Peritoneal Carcinoma", "Ovarian Carcinoma", "Fallopian Tube Carcinoma" ] }, "KeywordList":{ "Keyword":[ "peritoneal", "carcinoma", "ovarian", "fallopian tube", "neoadjuvant chemotherapy", "surgical debulking" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"28", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"neoadjuvant chemotherapy", "ArmGroupType":"Experimental", "ArmGroupDescription":"platinum-based neoadjuvant chemotherapy followed by interval surgical debulking with platinum-based adjuvant chemotherapy", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: neoadjuvant chemotherapy" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"neoadjuvant chemotherapy", "InterventionDescription":"platinum-based neoadjuvant chemotherapy followed by interval surgical debulking with platinum-based adjuvant chemotherapy", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "neoadjuvant chemotherapy" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Percentage of patients that achieve maximal surgical debulking", "PrimaryOutcomeDescription":"Percentage of patients that achieve maximal surgical debulking as defined by no gross residual disease following a Simon's 2-stage design.", "PrimaryOutcomeTimeFrame":"5 years" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nPatients with biopsy proven stage IIIC/IV epithelial ovarian cancer, primary peritoneal, fallopian tube carcinoma. If a core biopsy is not possible, fine-needle aspirate showing adenocarcinoma is acceptable in the setting of a pelvic mass and presence of metastasis outside the pelvis measuring at least 2 cm, regional lymph-node metastasis or proof of stage IV disease, and ratio of CA 125 to CEA greater than 25. If CA 125 to CEA ratio is 25 or lower, barium enema, gastroscopy, and mammography must be negative.\n\nPatients must have adequate:\n\nBone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/μl, equivalent to Common Toxicity Criteria for Adverse Events v3.0(CTCAE) Grade 1. This ANC cannot have been induced or supported by granulocyte colony stimulating factors.\nPlatelets greater than or equal to 100,000/μl, CTCAE Grade 0-1. Renal function: Creatinine ≤1.5 x institutional upper limit of normal ULN), CTCAE Grade 1.\nHepatic function: Bilirubin ≤ 1.5 x ULN, CTCAE Grade 1.SGOT and alkaline phosphatase ≤ 2.5 x ULN, CTCAE Grade 1.\nNeurologic function: Neuropathy (sensory and motor) less than or equal to CTCAE Grade 1.\nBlood coagulation parameters: PT such that international normalized ratio (INR) is ≤ 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin for management of venous thrombosis) and a PTT <1.2 x ULN.\nPatients must have a World Health Organization Performance Status ≤2.\nPatients must be a candidate for surgery.\nAn approved informed consent must be signed by the patient.\n\nExclusion Criteria:\n\nPatients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.\nPatients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.\nPatients with a known synchronous primary endometrial cancer, or a past history of primary endometrial cancer, are excluded, unless all of the following conditions are met: Stage not greater than IA, no more than superficial myometrial invasion, without vascular or lymphatic invasion, no poorly differentiated subtypes (including papillary serous, clear cell or other FIGO Grade 3 lesions).\nWith the exception of non-melanoma skin cancer and other specific malignancies noted above, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last five years or whose previous cancer treatment contraindicates this therapy are excluded.\nPatients with acute hepatitis or active infection that requires parenteral antibiotics are excluded.\nPatients with World Health Organization Performance Status of 3 or 4.\nPatients who are pregnant or nursing.\nPatients under the age of 18.\nPatients with a pelvic mass of any size that is causing pain, or other subjective symptoms that are intolerable to the patient.\nPatients who are not candidates for interval surgical debulking secondary to significant medical comorbidities.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Rachel Miller, MD", "OverallOfficialAffiliation":"Lucille P. Markey Cancer Center at University of Kentucky", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"University of Kentucky Markey Cancer Center", "LocationCity":"Lexington", "LocationState":"Kentucky", "LocationZip":"40536", "LocationCountry":"United States" } ] } }, "IPDSharingStatementModule":{ "IPDSharing":"No" } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000002277", "ConditionMeshTerm":"Carcinoma" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000009375", "ConditionAncestorTerm":"Neoplasms, Glandular and Epithelial" },{ "ConditionAncestorId":"D000009370", "ConditionAncestorTerm":"Neoplasms by Histologic Type" },{ "ConditionAncestorId":"D000009369", "ConditionAncestorTerm":"Neoplasms" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M4116", "ConditionBrowseLeafName":"Carcinoma", "ConditionBrowseLeafAsFound":"Carcinoma", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M11557", "ConditionBrowseLeafName":"Ovarian Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M1704", "ConditionBrowseLeafName":"Carcinoma, Ovarian Epithelial", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10903", "ConditionBrowseLeafName":"Neoplasms, Glandular and Epithelial", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10898", "ConditionBrowseLeafName":"Neoplasms by Histologic Type", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T4380", "ConditionBrowseLeafName":"Ovarian Cancer", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T4382", "ConditionBrowseLeafName":"Ovarian Epithelial Cancer", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T2201", "ConditionBrowseLeafName":"Fallopian Tube Cancer", "ConditionBrowseLeafAsFound":"Fallopian Tube Carcinoma", "ConditionBrowseLeafRelevance":"high" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC04", "ConditionBrowseBranchName":"Cancers and Other Neoplasms" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BXS", "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions" },{ "ConditionBrowseBranchAbbrev":"BC19", "ConditionBrowseBranchName":"Gland and Hormone Related Diseases" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }