Nctid:
NCT00002495
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-27"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D008223", "term"=>"Lymphoma"}, {"id"=>"D006689", "term"=>"Hodgkin Disease"}], "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"=>"M9751", "name"=>"Hodgkin Disease", "asFound"=>"Hodgkin's Disease", "relevance"=>"HIGH"}, {"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", "relevance"=>"LOW"}, {"id"=>"T2817", "name"=>"Hodgkin Lymphoma", "asFound"=>"Hodgkin's Disease", "relevance"=>"HIGH"}], "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"=>"D004317", "term"=>"Doxorubicin"}, {"id"=>"C506643", "term"=>"Liposomal doxorubicin"}, {"id"=>"D014747", "term"=>"Vinblastine"}], "ancestors"=>[{"id"=>"D000903", "term"=>"Antibiotics, Antineoplastic"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D059005", "term"=>"Topoisomerase II Inhibitors"}, {"id"=>"D059003", "term"=>"Topoisomerase Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000972", "term"=>"Antineoplastic Agents, Phytogenic"}, {"id"=>"D050257", "term"=>"Tubulin Modulators"}, {"id"=>"D050256", "term"=>"Antimitotic Agents"}, {"id"=>"D050258", "term"=>"Mitosis Modulators"}], "browseLeaves"=>[{"id"=>"M7492", "name"=>"Doxorubicin", "asFound"=>"Arterial", "relevance"=>"HIGH"}, {"id"=>"M227339", "name"=>"Liposomal doxorubicin", "asFound"=>"Arterial", "relevance"=>"HIGH"}, {"id"=>"M17492", "name"=>"Vinblastine", "asFound"=>"Lung Disease", "relevance"=>"HIGH"}, {"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"M4224", "name"=>"Antibiotics, Antitubercular", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M26197", "name"=>"Tubulin Modulators", "relevance"=>"LOW"}, {"id"=>"M26196", "name"=>"Antimitotic Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>348}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1992-09"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2017-02", "completionDateStruct"=>{"date"=>"2014-04", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2017-02-16", "studyFirstSubmitDate"=>"1999-11-01", "studyFirstSubmitQcDate"=>"2004-07-16", "lastUpdatePostDateStruct"=>{"date"=>"2017-02-20", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2004-07-19", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"2000-11", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"progression-free survival", "timeFrame"=>"every 3 months while on protocol treatment, then every 6 months for 2 years, then annually thereafter"}, {"measure"=>"overall survival", "timeFrame"=>"every 3 months while on protocol treatment, then every 6 months for 2 years, then annually thereafter"}]}, "oversightModule"=>{"oversightHasDmc"=>true}, "conditionsModule"=>{"keywords"=>["stage I adult Hodgkin lymphoma", "stage II adult Hodgkin lymphoma"], "conditions"=>["Lymphoma"]}, "referencesModule"=>{"references"=>[{"type"=>"RESULT", "citation"=>"Ganz PA, Moinpour CM, McCoy S, et al.: Predictors of vitality (energy/fatigue) in early stage Hodgkin's disease (HD): results from Southwest Oncology Group (SWOG) study 9133. [Abstract] J Clin Oncol 22 (Suppl 14): A-6546, 569s, 2004."}, {"pmid"=>"12972528", "type"=>"RESULT", "citation"=>"Ganz PA, Moinpour CM, Pauler DK, Kornblith AB, Gaynor ER, Balcerzak SP, Gatti GS, Erba HP, McCoy S, Press OW, Fisher RI. Health status and quality of life in patients with early-stage Hodgkin's disease treated on Southwest Oncology Group Study 9133. J Clin Oncol. 2003 Sep 15;21(18):3512-9. doi: 10.1200/JCO.2003.01.044. Erratum In: J Clin Oncol. 2013 Jun 10;31(17):2231-2."}, {"pmid"=>"11709567", "type"=>"RESULT", "citation"=>"Press OW, LeBlanc M, Lichter AS, Grogan TM, Unger JM, Wasserman TH, Gaynor ER, Peterson BA, Miller TP, Fisher RI. Phase III randomized intergroup trial of subtotal lymphoid irradiation versus doxorubicin, vinblastine, and subtotal lymphoid irradiation for stage IA to IIA Hodgkin's disease. J Clin Oncol. 2001 Nov 15;19(22):4238-44. doi: 10.1200/JCO.2001.19.22.4238."}, {"type"=>"RESULT", "citation"=>"Press OW, LeBlanc M, Lichter A, et al.: A phase III randomized intergroup trial of subtotal lymphoid irradiation (STLI) versus doxorubicin, vinblastine, and STLI for stage IA-IIA Hodgkin's disease (SWOG 9133, CALGB 9391). [Abstract] Blood 96(11 pt 1), A-2471, 575a, 2000."}]}, "descriptionModule"=>{"briefSummary"=>"RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.\n\nPURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without doxorubicin and vinblastine in treating patients with stage I or stage II Hodgkin's disease.", "detailedDescription"=>"OBJECTIVES: I. Compare progression-free and overall survival of patients with clinical Stage IA/IIA Hodgkin's disease who have not undergone laparotomy and who are randomized to treatment with subtotal nodal irradiation with vs. without 3 courses of doxorubicin/vinblastine. II. Compare the long-term toxicities associated with these treatments, including cardiopulmonary toxicity, secondary malignancies, and infertility. III. Identify subgroups of patients (based on age, gender, tumor histology, number of disease sites, and presence of high neck presentation) that are particularly responsive to these treatments.\n\nOUTLINE: Randomized study. Arm I: Radiotherapy. Subtotal nodal irradiation using megavoltage equipment (4-10 MeV). Arm II: 2-Drug Combination Chemotherapy followed by Radiotherapy. Doxorubicin, DOX, NSC-123127; Vinblastine, VBL, NSC-49842; followed by subtotal nodal irradiation as in Arm I.\n\nPROJECTED ACCRUAL: 210 patients/arm will be enrolled over about 7 years."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"16 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS: Biopsy-proven Hodgkin's disease, subclassified according to the Rye system Clinical Stages IA, IEA, IIA, and IIEA according to modified Ann Arbor system Staging laparotomy not allowed Completely resected disease allowed Residual disease, if present, must be bidimensionally measurable No mediastinal mass greater than 1/3 the maximum chest diameter No infradiaphragmatic presentation No pericardial E lesions (small pericardial effusions in the absence of nodular pericardial disease allowed) Concurrent registration on protocol SWOG-9208 (quality-of-life study) required unless patient does not understand or read English\n\nPATIENT CHARACTERISTICS: Age: 16 and over Performance status: SWOG 0-2 Hematopoietic: AGC at least 2,000 Platelets within normal limits Hepatic: Bilirubin within normal limits Renal: Creatinine within normal limits Cardiovascular: LVEF normal No serious EKG abnormality Pulmonary: No serious pulmonary condition Other: No serious medical condition other than Hodgkin's disease No known AIDS or HIV-associated complex No second malignancy within 5 years except: Adequately treated nonmelanomatous skin cancer Adequately treated in situ carcinoma of the cervix No pregnant or lactating women Adequate contraception required of fertile patients Blood/body fluid analyses to determine eligibility completed within 14 days prior to registration; imaging studies for tumor measurement completed within 28 days prior to registration; screening exams other than blood/body fluid analyses, and imaging studies of nonmeasurable disease or uninvolved organs completed within 42 days prior to registration\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy for any reason Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for any reason Surgery: No staging laparotomy"}, "identificationModule"=>{"nctId"=>"NCT00002495", "briefTitle"=>"SWOG-9133 RT w/ or w/o Doxorubicin and Vinblastine in Stage I or Stage II Hodgkin's Disease", "organization"=>{"class"=>"NETWORK", "fullName"=>"SWOG Cancer Research Network"}, "officialTitle"=>"Randomized Trial of Subtotal Nodal Irradiation Versus Doxorubicin, Vinblastine and Subtotal Nodal Irradiation for Stage I-IIA Hodgkin's Disease", "orgStudyIdInfo"=>{"id"=>"CDR0000077691"}, "secondaryIdInfos"=>[{"id"=>"U10CA032102", "link"=>"https://reporter.nih.gov/quickSearch/U10CA032102", "type"=>"NIH"}, {"id"=>"SWOG-9133", "type"=>"OTHER", "domain"=>"SWOG"}, {"id"=>"CLB-9391", "type"=>"OTHER", "domain"=>"CALGB"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Nodal RT", "description"=>"subtotal nodal irradiation will consist of mantle and periaortic/spleen fields treated sequentially. Total dose 3600-4000 cGy over 20 fractions.", "interventionNames"=>["Radiation: standard subtotal nodal irradiation"]}, {"type"=>"EXPERIMENTAL", "label"=>"Chemotherapy + Nodal RT", "description"=>"3 cycles (28 days each) of chemotherapy (doxorubicin 25 mg/m\\^2 on days 1 and 15, vinblastine 6 mg/m\\^2 on days 1 and 15). Four weeks after last cycle, subtotal nodal irradiation (total dose 3600-4000 cGy over 20 fractions) will be given as described for the Nodal RT arm.", "interventionNames"=>["Drug: doxorubicin hydrochloride", "Drug: vinblastine", "Radiation: standard subtotal nodal irradiation"]}], "interventions"=>[{"name"=>"doxorubicin hydrochloride", "type"=>"DRUG", "description"=>"25 mg/m\\^2 on days 1 and 15", "armGroupLabels"=>["Chemotherapy + Nodal RT"]}, {"name"=>"vinblastine", "type"=>"DRUG", "description"=>"6 mg/m\\^2 on days 1 and 15", "armGroupLabels"=>["Chemotherapy + Nodal RT"]}, {"name"=>"standard subtotal nodal irradiation", "type"=>"RADIATION", "description"=>"3600-4000 cGy delivered over 20 fractions", "armGroupLabels"=>["Chemotherapy + Nodal RT", "Nodal RT"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"92093-0658", "city"=>"La Jolla", "state"=>"California", "country"=>"United States", "facility"=>"University of California San Diego Cancer Center", "geoPoint"=>{"lat"=>32.84727, "lon"=>-117.2742}}, {"zip"=>"19899", "city"=>"Wilmington", "state"=>"Delaware", "country"=>"United States", "facility"=>"CCOP - Christiana Care Health Services", "geoPoint"=>{"lat"=>39.74595, "lon"=>-75.54659}}, {"zip"=>"20307-5000", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Walter Reed Army Medical Center", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"33140", "city"=>"Miami Beach", "state"=>"Florida", "country"=>"United States", "facility"=>"CCOP - Mount Sinai Medical Center", "geoPoint"=>{"lat"=>25.79065, "lon"=>-80.13005}}, {"zip"=>"60637", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"University of Chicago Cancer Research Center", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"52242", "city"=>"Iowa City", "state"=>"Iowa", "country"=>"United States", "facility"=>"University of Iowa Hospitals and Clinics", "geoPoint"=>{"lat"=>41.66113, "lon"=>-91.53017}}, {"zip"=>"01655", "city"=>"Worcester", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"University of Massachusetts Memorial Medical Center", "geoPoint"=>{"lat"=>42.26259, "lon"=>-71.80229}}, {"zip"=>"55455", "city"=>"Minneapolis", "state"=>"Minnesota", "country"=>"United States", "facility"=>"University of Minnesota Cancer Center", "geoPoint"=>{"lat"=>44.97997, "lon"=>-93.26384}}, {"zip"=>"65203", "city"=>"Columbia", "state"=>"Missouri", "country"=>"United States", "facility"=>"Ellis Fischel Cancer Center - Columbia", "geoPoint"=>{"lat"=>38.95171, "lon"=>-92.33407}}, {"zip"=>"63110", "city"=>"Saint Louis", "state"=>"Missouri", "country"=>"United States", "facility"=>"Barnes-Jewish Hospital", "geoPoint"=>{"lat"=>38.62727, "lon"=>-90.19789}}, {"zip"=>"89106", "city"=>"Las Vegas", "state"=>"Nevada", "country"=>"United States", "facility"=>"CCOP - Southern Nevada Cancer Research Foundation", "geoPoint"=>{"lat"=>36.17497, "lon"=>-115.13722}}, {"zip"=>"03756", "city"=>"Lebanon", "state"=>"New Hampshire", "country"=>"United States", "facility"=>"Norris Cotton Cancer Center", "geoPoint"=>{"lat"=>43.64229, "lon"=>-72.25176}}, {"zip"=>"14263-0001", "city"=>"Buffalo", "state"=>"New York", "country"=>"United States", "facility"=>"Roswell Park Cancer Institute", "geoPoint"=>{"lat"=>42.88645, "lon"=>-78.87837}}, {"zip"=>"11030", "city"=>"Manhasset", "state"=>"New York", "country"=>"United States", "facility"=>"CCOP - North Shore University Hospital", "geoPoint"=>{"lat"=>40.79788, "lon"=>-73.69957}}, {"zip"=>"10029", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Mount Sinai Medical Center, NY", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"13210", "city"=>"Syracuse", "state"=>"New York", "country"=>"United States", "facility"=>"State University of New York - Upstate Medical University", "geoPoint"=>{"lat"=>43.04812, "lon"=>-76.14742}}, {"zip"=>"27104-4241", "city"=>"Winston-Salem", "state"=>"North Carolina", "country"=>"United States", "facility"=>"CCOP - Southeast Cancer Control Consortium", "geoPoint"=>{"lat"=>36.09986, "lon"=>-80.24422}}, {"zip"=>"27157-1082", "city"=>"Winston-Salem", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Comprehensive Cancer Center of Wake Forest University Baptist Medical Center", "geoPoint"=>{"lat"=>36.09986, "lon"=>-80.24422}}, {"zip"=>"02903", "city"=>"Providence", "state"=>"Rhode Island", "country"=>"United States", "facility"=>"Rhode Island Hospital", "geoPoint"=>{"lat"=>41.82399, "lon"=>-71.41283}}, {"zip"=>"38163", "city"=>"Memphis", "state"=>"Tennessee", "country"=>"United States", "facility"=>"University of Tennessee, Memphis Cancer Center", "geoPoint"=>{"lat"=>35.14953, "lon"=>-90.04898}}, {"zip"=>"05401-3498", "city"=>"Burlington", "state"=>"Vermont", "country"=>"United States", "facility"=>"Vermont Cancer Center", "geoPoint"=>{"lat"=>44.47588, "lon"=>-73.21207}}, {"zip"=>"23298-0037", "city"=>"Richmond", "state"=>"Virginia", "country"=>"United States", "facility"=>"MBCCOP - Massey Cancer Center", "geoPoint"=>{"lat"=>37.55376, "lon"=>-77.46026}}], "overallOfficials"=>[{"name"=>"Oliver W. Press, MD, PhD", "role"=>"STUDY_CHAIR", "affiliation"=>"University of Washington"}, {"name"=>"Todd H. Wasserman, MD", "role"=>"STUDY_CHAIR", "affiliation"=>"Washington University Siteman Cancer Center"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"SWOG Cancer Research Network", "class"=>"NETWORK"}, "collaborators"=>[{"name"=>"National Cancer Institute (NCI)", "class"=>"NIH"}, {"name"=>"Cancer and Leukemia Group B", "class"=>"NETWORK"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
