Nctid:
NCT00002565
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D008223", "term"=>"Lymphoma"}], "ancestors"=>[{"id"=>"D009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D008232", "term"=>"Lymphoproliferative Disorders"}, {"id"=>"D008206", "term"=>"Lymphatic Diseases"}, {"id"=>"D007160", "term"=>"Immunoproliferative Disorders"}, {"id"=>"D007154", "term"=>"Immune System Diseases"}], "browseLeaves"=>[{"id"=>"M11220", "name"=>"Lymphoma", "asFound"=>"Lymphoma", "relevance"=>"HIGH"}, {"id"=>"M11221", "name"=>"Lymphoma, Follicular", "relevance"=>"LOW"}, {"id"=>"M18831", "name"=>"Lymphoma, Large B-Cell, Diffuse", "relevance"=>"LOW"}, {"id"=>"M381", "name"=>"Plasmablastic Lymphoma", "relevance"=>"LOW"}, {"id"=>"M18830", "name"=>"Lymphoma, Large-Cell, Immunoblastic", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M11225", "name"=>"Lymphoproliferative Disorders", "relevance"=>"LOW"}, {"id"=>"M11203", "name"=>"Lymphatic Diseases", "relevance"=>"LOW"}, {"id"=>"M10206", "name"=>"Immunoproliferative Disorders", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}, {"id"=>"T3543", "name"=>"Lymphosarcoma", "asFound"=>"Lymphoma", "relevance"=>"HIGH"}, {"id"=>"T2361", "name"=>"Follicular Lymphoma", "relevance"=>"LOW"}, {"id"=>"T1866", "name"=>"Diffuse Large B-Cell Lymphoma", "relevance"=>"LOW"}, {"id"=>"T4586", "name"=>"Plasmablastic Lymphoma", "relevance"=>"LOW"}, {"id"=>"T3539", "name"=>"Lymphoma, Large-cell, Immunoblastic", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D003561", "term"=>"Cytarabine"}, {"id"=>"D011241", "term"=>"Prednisone"}, {"id"=>"D008775", "term"=>"Methylprednisolone"}, {"id"=>"D003520", "term"=>"Cyclophosphamide"}, {"id"=>"D007069", "term"=>"Ifosfamide"}, {"id"=>"D004317", "term"=>"Doxorubicin"}, {"id"=>"C506643", "term"=>"Liposomal doxorubicin"}, {"id"=>"D005047", "term"=>"Etoposide"}, {"id"=>"D014750", "term"=>"Vincristine"}, {"id"=>"D008942", "term"=>"Mitoxantrone"}, {"id"=>"D015255", "term"=>"Idarubicin"}, {"id"=>"D001761", "term"=>"Bleomycin"}], "ancestors"=>[{"id"=>"D007166", "term"=>"Immunosuppressive Agents"}, {"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D018501", "term"=>"Antirheumatic Agents"}, {"id"=>"D018906", "term"=>"Antineoplastic Agents, Alkylating"}, {"id"=>"D000477", "term"=>"Alkylating Agents"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D019653", "term"=>"Myeloablative Agonists"}, {"id"=>"D000903", "term"=>"Antibiotics, Antineoplastic"}, {"id"=>"D059005", "term"=>"Topoisomerase II Inhibitors"}, {"id"=>"D059003", "term"=>"Topoisomerase Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000893", "term"=>"Anti-Inflammatory Agents"}, {"id"=>"D005938", "term"=>"Glucocorticoids"}, {"id"=>"D006728", "term"=>"Hormones"}, {"id"=>"D006730", "term"=>"Hormones, Hormone Substitutes, and Hormone Antagonists"}, {"id"=>"D018931", "term"=>"Antineoplastic Agents, Hormonal"}, {"id"=>"D000972", "term"=>"Antineoplastic Agents, Phytogenic"}, {"id"=>"D000964", "term"=>"Antimetabolites, Antineoplastic"}, {"id"=>"D000963", "term"=>"Antimetabolites"}, {"id"=>"D000998", "term"=>"Antiviral Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D050257", "term"=>"Tubulin Modulators"}, {"id"=>"D050256", "term"=>"Antimitotic Agents"}, {"id"=>"D050258", "term"=>"Mitosis Modulators"}, {"id"=>"D000932", "term"=>"Antiemetics"}, {"id"=>"D001337", "term"=>"Autonomic Agents"}, {"id"=>"D018373", "term"=>"Peripheral Nervous System Agents"}, {"id"=>"D005765", "term"=>"Gastrointestinal Agents"}, {"id"=>"D018696", "term"=>"Neuroprotective Agents"}, {"id"=>"D020011", "term"=>"Protective Agents"}, {"id"=>"D000700", "term"=>"Analgesics"}, {"id"=>"D018689", "term"=>"Sensory System Agents"}], "browseLeaves"=>[{"id"=>"M8191", "name"=>"Etoposide", "asFound"=>"Different", "relevance"=>"HIGH"}, {"id"=>"M6182", "name"=>"Cisplatin", "relevance"=>"LOW"}, {"id"=>"M5042", "name"=>"Bleomycin", "asFound"=>"Salivary gland", "relevance"=>"HIGH"}, {"id"=>"M6727", "name"=>"Cyclophosphamide", "asFound"=>"Tablet", "relevance"=>"HIGH"}, {"id"=>"M7492", "name"=>"Doxorubicin", "asFound"=>"Intravenous infusion", "relevance"=>"HIGH"}, {"id"=>"M227339", "name"=>"Liposomal doxorubicin", "asFound"=>"Intravenous infusion", "relevance"=>"HIGH"}, {"id"=>"M17495", "name"=>"Vincristine", "asFound"=>"2 days", "relevance"=>"HIGH"}, {"id"=>"M11749", "name"=>"Methylprednisolone", "asFound"=>"Operative", "relevance"=>"HIGH"}, {"id"=>"M1833", "name"=>"Methylprednisolone Acetate", "relevance"=>"LOW"}, {"id"=>"M11750", "name"=>"Methylprednisolone Hemisuccinate", "relevance"=>"LOW"}, {"id"=>"M14120", "name"=>"Prednisolone", "relevance"=>"LOW"}, {"id"=>"M229449", "name"=>"Prednisolone acetate", "relevance"=>"LOW"}, {"id"=>"M211887", "name"=>"Prednisolone hemisuccinate", "relevance"=>"LOW"}, {"id"=>"M248881", "name"=>"Prednisolone phosphate", "relevance"=>"LOW"}, {"id"=>"M14121", "name"=>"Prednisone", "asFound"=>"Technique", "relevance"=>"HIGH"}, {"id"=>"M341643", "name"=>"Etoposide phosphate", "relevance"=>"LOW"}, {"id"=>"M6766", "name"=>"Cytarabine", "asFound"=>"PET", "relevance"=>"HIGH"}, {"id"=>"M11908", "name"=>"Mitoxantrone", "asFound"=>"Inactive", "relevance"=>"HIGH"}, {"id"=>"M10117", "name"=>"Ifosfamide", "asFound"=>"Degree", "relevance"=>"HIGH"}, {"id"=>"M230811", "name"=>"Isophosphamide mustard", "relevance"=>"LOW"}, {"id"=>"M17958", "name"=>"Idarubicin", "asFound"=>"Entire", "relevance"=>"HIGH"}, {"id"=>"M17811", "name"=>"Mesna", "relevance"=>"LOW"}, {"id"=>"M10212", "name"=>"Immunosuppressive Agents", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}, {"id"=>"M20604", "name"=>"Antirheumatic Agents", "relevance"=>"LOW"}, {"id"=>"M20942", "name"=>"Antineoplastic Agents, Alkylating", "relevance"=>"LOW"}, {"id"=>"M3820", "name"=>"Alkylating Agents", "relevance"=>"LOW"}, {"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"M4224", "name"=>"Antibiotics, Antitubercular", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M4217", "name"=>"Anti-Inflammatory Agents", "relevance"=>"LOW"}, {"id"=>"M9047", "name"=>"Glucocorticoids", "relevance"=>"LOW"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M9788", "name"=>"Hormone Antagonists", "relevance"=>"LOW"}, {"id"=>"M20966", "name"=>"Antineoplastic Agents, Hormonal", "relevance"=>"LOW"}, {"id"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M26197", "name"=>"Tubulin Modulators", "relevance"=>"LOW"}, {"id"=>"M26196", "name"=>"Antimitotic Agents", "relevance"=>"LOW"}, {"id"=>"M4251", "name"=>"Antiemetics", "relevance"=>"LOW"}, {"id"=>"M8881", "name"=>"Gastrointestinal Agents", "relevance"=>"LOW"}, {"id"=>"M20773", "name"=>"Neuroprotective Agents", "relevance"=>"LOW"}, {"id"=>"M21869", "name"=>"Protective Agents", "relevance"=>"LOW"}, {"id"=>"M4032", "name"=>"Analgesics", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Antirheumatic Agents", "abbrev"=>"ARhu"}, {"name"=>"Anti-Inflammatory Agents", "abbrev"=>"Infl"}, {"name"=>"Antiemetics", "abbrev"=>"AnEm"}, {"name"=>"Neuroprotective Agents", "abbrev"=>"NeuroAg"}, {"name"=>"Gastrointestinal Agents", "abbrev"=>"Gast"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Analgesics", "abbrev"=>"Analg"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>61}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1994-05-25", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2018-11", "completionDateStruct"=>{"date"=>"2007-02-05", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2018-11-13", "studyFirstSubmitDate"=>"1999-11-01", "studyFirstSubmitQcDate"=>"2004-06-29", "lastUpdatePostDateStruct"=>{"date"=>"2018-11-14", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2004-06-30", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"2007-02-05", "type"=>"ACTUAL"}}, "oversightModule"=>{"oversightHasDmc"=>false}, "conditionsModule"=>{"keywords"=>["stage I grade 3 follicular lymphoma", "stage I adult diffuse mixed cell lymphoma", "stage I adult diffuse large cell lymphoma", "stage I adult immunoblastic large cell lymphoma", "stage II grade 3 follicular lymphoma", "stage II adult diffuse mixed cell lymphoma", "stage II adult diffuse large cell lymphoma", "stage II adult immunoblastic large cell lymphoma", "stage III grade 3 follicular lymphoma", "stage III adult diffuse mixed cell lymphoma", "stage III adult diffuse large cell lymphoma", "stage III adult immunoblastic large cell lymphoma", "stage IV grade 3 follicular lymphoma", "stage IV adult diffuse mixed cell lymphoma", "stage IV adult diffuse large cell lymphoma", "stage IV adult immunoblastic large cell lymphoma", "contiguous stage II grade 3 follicular lymphoma", "contiguous stage II adult diffuse mixed cell lymphoma", "contiguous stage II adult immunoblastic large cell lymphoma", "contiguous stage II adult diffuse large cell lymphoma", "noncontiguous stage II grade 3 follicular lymphoma", "noncontiguous stage II adult diffuse mixed cell lymphoma", "noncontiguous stage II adult immunoblastic large cell lymphoma", "noncontiguous stage II adult diffuse large cell lymphoma"], "conditions"=>["Lymphoma"]}, "descriptionModule"=>{"briefSummary"=>"RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective for intermediate-grade or immunoblastic non-Hodgkin's lymphoma.\n\nPURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have intermediate-grade or immunoblastic non-Hodgkin's lymphoma.", "detailedDescription"=>"OBJECTIVES:\n\nI. Compare, in a randomized setting, the time to treatment failure and the survival of patients with poor-prognosis intermediate-grade or immunoblastic lymphoma treated with the standard regimen of CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) versus the new alternating triple therapy (ATT) of IdSHAP (idarubicin, cisplatin, cytarabine, methylprednisolone), BIdCOS (idarubicin, vincristine, bleomycin, cyclophosphamide, methylprednisolone), and MINE (mesna, ifosfamide, mitoxantrone, etoposide).\n\nII. Compare the complete response rate achieved with ATT versus standard CHOP.\n\nIII. Assess the feasibility of delivering full standard doses of chemotherapy to patients over 60 years of age who receive granulocyte colony stimulating factor support.\n\nIV. Compare the predictive capability of the M.D. Anderson Tumor Score System versus the International Index System.\n\nOUTLINE: Randomized study. The following acronyms are used: ARA-C Cytarabine, NSC-63878 BLEO Bleomycin, NSC-125066 CDDP Cisplatin, NSC-119875 CTX Cyclophosphamide, NSC-26271 DHAD Mitoxantrone, NSC-301739 DOX Doxorubicin, NSC-123127 G-CSF Granulocyte Colony-Stimulating Factor (source unspecified) IDA Idarubicin, NSC-256439 IFF Ifosfamide, NSC-109724 MePRDL Methylprednisolone succinate Mesna Mercaptoethane sulfonate, NSC-113891 PRED Prednisone, NSC-10023 VCR Vincristine, NSC-67574 VP-16 Etoposide, NSC-141540\n\nArm I: Sequential 4-, 5-, and 3-Drug Combination Chemotherapy. IdSHAP: IDA/CDDP/ARA-C/MePRDL; followed by BIdCOS: BLEO/IDA/CTX/VCR/MePRDL; followed by MINE: Mesna/IFF/DHAD/VP-16.\n\nArm II: 4-Drug Combination Chemotherapy. CHOP: CTX/DOX/VCR/PRED.\n\nPROJECTED ACCRUAL: 218 evaluable patients will be accrued over approximately 31 months to this multicenter study. If either arm is significantly inferior at interim analyses after 31 and 60 treatment failures, consideration will be given to early closure."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"15 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS: Previously untreated non-Hodgkin's lymphoma (NHL) of one of the following histologies: Diffuse large cell Follicular large non-cleaved cell Diffuse mixed cell Immunoblastic At least 2 of the following poor-prognosis factors required: Age over 60 Performance status greater than 1 Any elevation of LDH More than 1 extranodal site Ann Arbor stage III or IV T- and B-cell NHL eligible if meeting all above criteria No primary CNS lymphoma Brain involvement eligible if not primary\n\nPATIENT CHARACTERISTICS: Age: Over 15 Performance status: Any status Hematopoietic: (unless secondary to tumor) Absolute granulocyte count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Elevation secondary to tumor discussed with study chairman Renal: (unless secondary to tumor) Creatinine no greater than 1.5 mg/dL Cardiovascular: Left ventricular ejection fraction greater than 55% by echocardiography Pulmonary: No chronic obstructive or restrictive lung disease Pulmonary consultation required in cases of doubt Other: No HIV infection No prior malignancy with less than a 90% 5-year survival probability No patients unable or unlikely to adhere to treatment because of geographic, economic, emotional, or social factors No unwillingness to accept blood product transfusions or other supportive measures (e.g., antibiotics)\n\nPRIOR CONCURRENT THERAPY: No prior therapy"}, "identificationModule"=>{"nctId"=>"NCT00002565", "briefTitle"=>"Combination Chemotherapy in Treating Patients With Intermediate-Grade or Immunoblastic Non-Hodgkin's Lymphoma", "organization"=>{"class"=>"OTHER", "fullName"=>"M.D. Anderson Cancer Center"}, "officialTitle"=>"RANDOMIZED COMPARISON OF ALTERNATING TRIPLE THERAPY (\"ATT\") VERUS CHOP IN PATIENTS WITH INTERMEDIATE GRADE LYMPHOMAS AND IMMUNOBLASTIC LYMPHOMAS WITH INTERNATIONAL INDEX 2-5", "orgStudyIdInfo"=>{"id"=>"CDR0000063574"}, "secondaryIdInfos"=>[{"id"=>"MDA-DM-94017"}, {"id"=>"NCI-T94-0040D"}, {"id"=>"DM94-017", "type"=>"OTHER", "domain"=>"UT MD Anderson Cancer Center"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Arm I", "description"=>"Sequential 4-, 5-, and 3-Drug Combination Chemotherapy. IdSHAP: IDA/CDDP/ARA-C/MePRDL; followed by BIdCOS: BLEO/IDA/CTX/VCR/MePRDL; followed by MINE: Mesna/IFF/DHAD/VP-16.\n\nAlternating triple therapy (ATT) of IdSHAP (idarubicin, cisplatin, cytarabine, methylprednisolone), BIdCOS (idarubicin, vincristine, bleomycin, cyclophosphamide, methylprednisolone), and MINE (mesna, ifosfamide, mitoxantrone, etoposide).", "interventionNames"=>["Biological: bleomycin sulfate", "Drug: cisplatin", "Drug: cyclophosphamide", "Drug: cytarabine", "Drug: etoposide", "Drug: idarubicin", "Drug: ifosfamide", "Drug: mesna", "Drug: methylprednisolone", "Drug: mitoxantrone hydrochloride", "Drug: vincristine sulfate"]}, {"type"=>"EXPERIMENTAL", "label"=>"Arm II", "description"=>"4-Drug Combination Chemotherapy. CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone): CTX/DOX/VCR/PRED.", "interventionNames"=>["Drug: CHOP regimen", "Drug: cyclophosphamide", "Drug: doxorubicin hydrochloride", "Drug: prednisone", "Drug: vincristine sulfate"]}], "interventions"=>[{"name"=>"bleomycin sulfate", "type"=>"BIOLOGICAL", "armGroupLabels"=>["Arm I"]}, {"name"=>"CHOP regimen", "type"=>"DRUG", "armGroupLabels"=>["Arm II"]}, {"name"=>"cisplatin", "type"=>"DRUG", "armGroupLabels"=>["Arm I"]}, {"name"=>"cyclophosphamide", "type"=>"DRUG", "armGroupLabels"=>["Arm I", "Arm II"]}, {"name"=>"cytarabine", "type"=>"DRUG", "armGroupLabels"=>["Arm I"]}, {"name"=>"doxorubicin hydrochloride", "type"=>"DRUG", "armGroupLabels"=>["Arm II"]}, {"name"=>"etoposide", "type"=>"DRUG", "armGroupLabels"=>["Arm I"]}, {"name"=>"idarubicin", "type"=>"DRUG", "armGroupLabels"=>["Arm I"]}, {"name"=>"ifosfamide", "type"=>"DRUG", "armGroupLabels"=>["Arm I"]}, {"name"=>"mesna", "type"=>"DRUG", "armGroupLabels"=>["Arm I"]}, {"name"=>"methylprednisolone", "type"=>"DRUG", "armGroupLabels"=>["Arm I"]}, {"name"=>"mitoxantrone hydrochloride", "type"=>"DRUG", "armGroupLabels"=>["Arm I"]}, {"name"=>"prednisone", "type"=>"DRUG", "armGroupLabels"=>["Arm II"]}, {"name"=>"vincristine sulfate", "type"=>"DRUG", "armGroupLabels"=>["Arm I", "Arm II"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"77030", "city"=>"Houston", "state"=>"Texas", "country"=>"United States", "facility"=>"University of Texas - MD Anderson Cancer Center", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}, {"zip"=>"01224--010", "city"=>"Sao Paulo", "country"=>"Brazil", "facility"=>"Faculdade de Medicina do ABC", "geoPoint"=>{"lat"=>-23.5475, "lon"=>-46.63611}}, {"zip"=>"5951", "city"=>"Santiago", "country"=>"Chile", "facility"=>"Clinica Alemana", "geoPoint"=>{"lat"=>-33.45694, "lon"=>-70.64827}}], "overallOfficials"=>[{"name"=>"Fernando Cabanillas, MD", "role"=>"STUDY_CHAIR", "affiliation"=>"M.D. Anderson Cancer Center"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"M.D. Anderson Cancer Center", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"National Cancer Institute (NCI)", "class"=>"NIH"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
