Nctid:
NCT00002525
Payload:
{"hasResults"=>true, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-11-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D003110", "term"=>"Colonic Neoplasms"}], "ancestors"=>[{"id"=>"D015179", "term"=>"Colorectal Neoplasms"}, {"id"=>"D007414", "term"=>"Intestinal Neoplasms"}, {"id"=>"D005770", "term"=>"Gastrointestinal Neoplasms"}, {"id"=>"D004067", "term"=>"Digestive System Neoplasms"}, {"id"=>"D009371", "term"=>"Neoplasms by Site"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D004066", "term"=>"Digestive System Diseases"}, {"id"=>"D005767", "term"=>"Gastrointestinal Diseases"}, {"id"=>"D003108", "term"=>"Colonic Diseases"}, {"id"=>"D007410", "term"=>"Intestinal Diseases"}], "browseLeaves"=>[{"id"=>"M6338", "name"=>"Colonic Neoplasms", "asFound"=>"Colon Cancer", "relevance"=>"HIGH"}, {"id"=>"M17890", "name"=>"Colorectal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M10448", "name"=>"Intestinal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M7256", "name"=>"Digestive System Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8886", "name"=>"Gastrointestinal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M6336", "name"=>"Colonic Diseases", "relevance"=>"LOW"}, {"id"=>"M10444", "name"=>"Intestinal Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D002955", "term"=>"Leucovorin"}, {"id"=>"D013763", "term"=>"Tetrahydrofolates"}, {"id"=>"D005575", "term"=>"Formyltetrahydrofolates"}, {"id"=>"D005472", "term"=>"Fluorouracil"}, {"id"=>"D002118", "term"=>"Calcium"}, {"id"=>"D058766", "term"=>"Levoleucovorin"}], "ancestors"=>[{"id"=>"D000077264", "term"=>"Calcium-Regulating Hormones and Agents"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000963", "term"=>"Antimetabolites"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000964", "term"=>"Antimetabolites, Antineoplastic"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D007166", "term"=>"Immunosuppressive Agents"}, {"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D000931", "term"=>"Antidotes"}, {"id"=>"D020011", "term"=>"Protective Agents"}, {"id"=>"D014803", "term"=>"Vitamin B Complex"}, {"id"=>"D014815", "term"=>"Vitamins"}, {"id"=>"D018977", "term"=>"Micronutrients"}], "browseLeaves"=>[{"id"=>"M8600", "name"=>"Fluorouracil", "asFound"=>"Outcomes", "relevance"=>"HIGH"}, {"id"=>"M6191", "name"=>"Leucovorin", "asFound"=>"May", "relevance"=>"HIGH"}, {"id"=>"M5381", "name"=>"Calcium", "asFound"=>"Double-blind", "relevance"=>"HIGH"}, {"id"=>"M29233", "name"=>"Levoleucovorin", "asFound"=>"May", "relevance"=>"HIGH"}, {"id"=>"M5398", "name"=>"Calcium, Dietary", "relevance"=>"LOW"}, {"id"=>"M8618", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"M16531", "name"=>"Tetrahydrofolates", "asFound"=>"Decadrol", "relevance"=>"HIGH"}, {"id"=>"M8697", "name"=>"Formyltetrahydrofolates", "asFound"=>"Toremifene", "relevance"=>"HIGH"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}, {"id"=>"M10212", "name"=>"Immunosuppressive Agents", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}, {"id"=>"M4250", "name"=>"Antidotes", "relevance"=>"LOW"}, {"id"=>"M21869", "name"=>"Protective Agents", "relevance"=>"LOW"}, {"id"=>"M17558", "name"=>"Vitamins", "relevance"=>"LOW"}, {"id"=>"M17546", "name"=>"Vitamin B Complex", "relevance"=>"LOW"}, {"id"=>"M21009", "name"=>"Micronutrients", "relevance"=>"LOW"}, {"id"=>"M16885", "name"=>"Trace Elements", "relevance"=>"LOW"}, {"id"=>"T447", "name"=>"Folinic Acid", "asFound"=>"May", "relevance"=>"HIGH"}, {"id"=>"T446", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"T448", "name"=>"Folate", "relevance"=>"LOW"}, {"id"=>"T120", "name"=>"Cola", "relevance"=>"LOW"}, {"id"=>"T475", "name"=>"Vitamin B9", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Micronutrients", "abbrev"=>"Micro"}, {"name"=>"Bone Density Conservation Agents", "abbrev"=>"BDCA"}, {"name"=>"Hematinics", "abbrev"=>"Hemat"}, {"name"=>"Vitamins", "abbrev"=>"Vi"}, {"name"=>"Herbal and Botanical", "abbrev"=>"HB"}]}}, "resultsSection"=>{"moreInfoModule"=>{"pointOfContact"=>{"phone"=>"617-632-3012", "title"=>"Study statistician", "organization"=>"ECOG-ACRIN Statistical Office"}, "certainAgreement"=>{"restrictionType"=>"LTE60", "piSponsorEmployee"=>false, "restrictiveAgreement"=>true}}, "adverseEventsModule"=>{"timeFrame"=>"Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy.", "description"=>"After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.", "eventGroups"=>[{"id"=>"EG000", "title"=>"Arm I (Perioperative 5-FU)", "description"=>"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.\n\nAfter surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m\\^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m\\^2 IV push on days 1-5\n\nfluorouracil: Perioperative 5-FU: 600 mg/m\\^2/d x 7 days continuous IV, beginning within 24 hours of surgery\n\nAfter surgery, 5-FU was given 425 mg/m\\^2 IV push on days 1-5\n\nleucovorin calcium: given after surgery at dose of 20mg/m\\^2 IV push on days 1-5", "otherNumAtRisk"=>418, "otherNumAffected"=>236, "seriousNumAtRisk"=>418, "seriousNumAffected"=>75}, {"id"=>"EG001", "title"=>"Arm II (No Perioperative 5-FU)", "description"=>"Patients receive no perioperative fluorouracil.\n\nAfter surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m\\^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m\\^2 IV push on days 1-5\n\nfluorouracil: Perioperative 5-FU: 600 mg/m\\^2/d x 7 days continuous IV, beginning within 24 hours of surgery\n\nAfter surgery, 5-FU was given 425 mg/m\\^2 IV push on days 1-5\n\nleucovorin calcium: given after surgery at dose of 20mg/m\\^2 IV push on days 1-5", "otherNumAtRisk"=>422, "otherNumAffected"=>9, "seriousNumAtRisk"=>422, "seriousNumAffected"=>4}, {"id"=>"EG002", "title"=>"Adjuvant Chemotherapy-- 5-FU+Levamisolem", "description"=>"Beginning 21-35 days after surgery, patients with stage IIC or III disease enrolled between September 1997 and May 2000 receive the following adjuvant chemotherapy:\n\nLeucovorin: 20 mg/m² IV push days 1-5 5-FU: 425 mg/m² IV push days 1-5, give immediately after Leucovorin\n\nA cycle of therapy consisted of 5 consecutive days of chemotherapy. Cycles were repeated at the end of 4 weeks (day 29), 8 weeks (day 57) and then every 4 weeks for a total of 6 cycles.\n\nAll patients with Dukes' B3/C disease for who adverse vents were collected were included in the analysis.", "otherNumAtRisk"=>171, "otherNumAffected"=>167, "seriousNumAtRisk"=>171, "seriousNumAffected"=>76}, {"id"=>"EG003", "title"=>"Adjuvant Chemotherapy-- 5-FU+Leucovovin", "description"=>"After surgery, patients with stage IIC or III disease enrolled between August 1993 and August 1997 receive the following adjuvant chemotherapy:\n\nLevamisole: 50 mg PO TID Days 1-3 and Days 15-17; 50 mg PO TID x 3 days beginning Day 29, repeat every 14 days for 11 months.\n\n5-FU: 450 mg/m²/day IV bolus for Days 1-5. 450 mg/m² IV bolus once weekly beginning Day 29, repeat weekly for a maximum of 11 months.\n\nAll patients with Dukes' B3/C disease for who adverse vents were collected were included in the analysis.", "otherNumAtRisk"=>61, "otherNumAffected"=>58, "seriousNumAtRisk"=>61, "seriousNumAffected"=>32}], "otherEvents"=>[{"term"=>"Leukopenia", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>418, "numAffected"=>25}, {"groupId"=>"EG001", "numAtRisk"=>422, "numAffected"=>2}, {"groupId"=>"EG002", "numAtRisk"=>171, "numAffected"=>78}, {"groupId"=>"EG003", "numAtRisk"=>61, "numAffected"=>32}], "organSystem"=>"Investigations", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE (2.0)"}, {"term"=>"Thrombocytopenia", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>418, "numAffected"=>24}, {"groupId"=>"EG001", "numAtRisk"=>422, "numAffected"=>0}, {"groupId"=>"EG002", "numAtRisk"=>171, "numAffected"=>66}, {"groupId"=>"EG003", "numAtRisk"=>61, "numAffected"=>14}], "organSystem"=>"Investigations", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE (2.0)"}, {"term"=>"Anemia", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>418, "numAffected"=>209}, {"groupId"=>"EG001", "numAtRisk"=>422, "numAffected"=>7}, {"groupId"=>"EG002", "numAtRisk"=>171, "numAffected"=>105}, {"groupId"=>"EG003", "numAtRisk"=>61, "numAffected"=>43}], "organSystem"=>"Blood and lymphatic system disorders", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE (2.0)"}, {"term"=>"Fever (No Infection)", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>418, "numAffected"=>45}, {"groupId"=>"EG001", "numAtRisk"=>422, "numAffected"=>1}, {"groupId"=>"EG002", "numAtRisk"=>171, "numAffected"=>15}, {"groupId"=>"EG003", "numAtRisk"=>61, "numAffected"=>7}], "organSystem"=>"General disorders", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE (2.0)"}, {"term"=>"Nausea/vomiting", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>418, "numAffected"=>116}, {"groupId"=>"EG001", "numAtRisk"=>422, "numAffected"=>4}, {"groupId"=>"EG002", "numAtRisk"=>171, "numAffected"=>94}, {"groupId"=>"EG003", "numAtRisk"=>61, "numAffected"=>27}], "organSystem"=>"Gastrointestinal disorders", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE (2.0)"}, {"term"=>"Vomiting", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>418, "numAffected"=>60}, {"groupId"=>"EG001", "numAtRisk"=>422, "numAffected"=>3}, {"groupId"=>"EG002", "numAtRisk"=>171, "numAffected"=>45}, {"groupId"=>"EG003", "numAtRisk"=>61, "numAffected"=>11}], "organSystem"=>"Gastrointestinal disorders", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE (2.0)"}, {"term"=>"Diarrhea", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>418, "numAffected"=>67}, {"groupId"=>"EG001", "numAtRisk"=>422, "numAffected"=>3}, {"groupId"=>"EG002", "numAtRisk"=>171, "numAffected"=>74}, {"groupId"=>"EG003", "numAtRisk"=>61, "numAffected"=>27}], "organSystem"=>"Gastrointestinal disorders", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE (2.0)"}, {"term"=>"Stomatitis", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>418, "numAffected"=>71}, {"groupId"=>"EG001", "numAtRisk"=>422, "numAffected"=>1}, {"groupId"=>"EG002", "numAtRisk"=>171, "numAffected"=>59}, {"groupId"=>"EG003", "numAtRisk"=>61, "numAffected"=>20}], "organSystem"=>"Gastrointestinal disorders", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE (2.0)"}, {"term"=>"Skin", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>418, "numAffected"=>39}, {"groupId"=>"EG001", "numAtRisk"=>422, "numAffected"=>2}, {"groupId"=>"EG002", "numAtRisk"=>171, "numAffected"=>73}, {"groupId"=>"EG003", "numAtRisk"=>61, "numAffected"=>24}], "organSystem"=>"Skin and subcutaneous tissue disorders", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE (2.0)"}, {"term"=>"Neuro-clinical", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>418, "numAffected"=>21}, {"groupId"=>"EG001", "numAtRisk"=>422, "numAffected"=>1}, {"groupId"=>"EG002", "numAtRisk"=>171, "numAffected"=>84}, {"groupId"=>"EG003", "numAtRisk"=>61, "numAffected"=>18}], "organSystem"=>"Nervous system disorders", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE (2.0)"}, {"term"=>"Infection", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>418, "numAffected"=>0}, {"groupId"=>"EG001", "numAtRisk"=>422, "numAffected"=>0}, {"groupId"=>"EG002", "numAtRisk"=>171, "numAffected"=>33}, {"groupId"=>"EG003", "numAtRisk"=>61, "numAffected"=>9}], "organSystem"=>"Infections and infestations", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE (2.0)"}, {"term"=>"Neuro-motor", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>418, "numAffected"=>6}, {"groupId"=>"EG001", "numAtRisk"=>422, "numAffected"=>0}, {"groupId"=>"EG002", "numAtRisk"=>171, "numAffected"=>33}, {"groupId"=>"EG003", "numAtRisk"=>61, "numAffected"=>3}], "organSystem"=>"Nervous system disorders", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE (2.0)"}, {"term"=>"Neuro-psych", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>418, "numAffected"=>9}, {"groupId"=>"EG001", "numAtRisk"=>422, "numAffected"=>1}, {"groupId"=>"EG002", "numAtRisk"=>171, "numAffected"=>17}, {"groupId"=>"EG003", "numAtRisk"=>61, "numAffected"=>5}], "organSystem"=>"Nervous system disorders", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE (2.0)"}], "seriousEvents"=>[{"term"=>"Leukopenia", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>418, "numAffected"=>3}, {"groupId"=>"EG001", "numAtRisk"=>422, "numAffected"=>1}, {"groupId"=>"EG002", "numAtRisk"=>171, "numAffected"=>23}, {"groupId"=>"EG003", "numAtRisk"=>61, "numAffected"=>8}], "organSystem"=>"Investigations", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE (Unspecified)"}, {"term"=>"Granulocytopenia", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>418, "numAffected"=>1}, {"groupId"=>"EG001", "numAtRisk"=>422, "numAffected"=>0}, {"groupId"=>"EG002", "numAtRisk"=>171, "numAffected"=>4}, {"groupId"=>"EG003", "numAtRisk"=>61, "numAffected"=>1}], "organSystem"=>"Investigations", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE (Unspecified)"}, {"term"=>"Anemia", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>418, "numAffected"=>22}, {"groupId"=>"EG001", "numAtRisk"=>422, "numAffected"=>0}, {"groupId"=>"EG002", "numAtRisk"=>171, "numAffected"=>1}, {"groupId"=>"EG003", "numAtRisk"=>61, "numAffected"=>1}], "organSystem"=>"Blood and lymphatic system disorders", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE (2.0)"}, {"term"=>"Infection", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>418, "numAffected"=>9}, {"groupId"=>"EG001", "numAtRisk"=>422, "numAffected"=>0}, {"groupId"=>"EG002", "numAtRisk"=>171, "numAffected"=>1}, {"groupId"=>"EG003", "numAtRisk"=>61, "numAffected"=>3}], "organSystem"=>"Infections and infestations", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE (2.0)"}, {"term"=>"Nausea/Vomiting", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>418, "numAffected"=>7}, {"groupId"=>"EG001", "numAtRisk"=>422, "numAffected"=>0}, {"groupId"=>"EG002", "numAtRisk"=>171, "numAffected"=>8}, {"groupId"=>"EG003", "numAtRisk"=>61, "numAffected"=>4}], "organSystem"=>"Gastrointestinal disorders", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE (Unspecified)"}, {"term"=>"Vomiting", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>418, "numAffected"=>6}, {"groupId"=>"EG001", "numAtRisk"=>422, "numAffected"=>0}, {"groupId"=>"EG002", "numAtRisk"=>171, "numAffected"=>5}, {"groupId"=>"EG003", "numAtRisk"=>61, "numAffected"=>2}], "organSystem"=>"Gastrointestinal disorders", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE (2.0)"}, {"term"=>"Diarrhea", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>418, "numAffected"=>14}, {"groupId"=>"EG001", "numAtRisk"=>422, "numAffected"=>0}, {"groupId"=>"EG002", "numAtRisk"=>171, "numAffected"=>20}, {"groupId"=>"EG003", "numAtRisk"=>61, "numAffected"=>15}], "organSystem"=>"Gastrointestinal disorders", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE (2.0)"}, {"term"=>"Stomatitis", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>418, "numAffected"=>11}, {"groupId"=>"EG001", "numAtRisk"=>422, "numAffected"=>0}, {"groupId"=>"EG002", "numAtRisk"=>171, "numAffected"=>6}, {"groupId"=>"EG003", "numAtRisk"=>61, "numAffected"=>9}], "organSystem"=>"Gastrointestinal disorders", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE (2.0)"}, {"term"=>"Liver", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>418, "numAffected"=>2}, {"groupId"=>"EG001", "numAtRisk"=>422, "numAffected"=>0}, {"groupId"=>"EG002", "numAtRisk"=>171, "numAffected"=>5}, {"groupId"=>"EG003", "numAtRisk"=>61, "numAffected"=>1}], "organSystem"=>"Hepatobiliary disorders", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE (2.0)"}, {"term"=>"Pulmonary", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>418, "numAffected"=>4}, {"groupId"=>"EG001", "numAtRisk"=>422, "numAffected"=>0}, {"groupId"=>"EG002", "numAtRisk"=>171, "numAffected"=>1}, {"groupId"=>"EG003", "numAtRisk"=>61, "numAffected"=>1}], "organSystem"=>"Respiratory, thoracic and mediastinal disorders", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE (2.0)"}, {"term"=>"Cardiac", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>418, "numAffected"=>9}, {"groupId"=>"EG001", "numAtRisk"=>422, "numAffected"=>0}, {"groupId"=>"EG002", "numAtRisk"=>171, "numAffected"=>2}, {"groupId"=>"EG003", "numAtRisk"=>61, "numAffected"=>2}], "organSystem"=>"Cardiac disorders", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE (2.0)"}, {"term"=>"Hypertension", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>418, "numAffected"=>1}, {"groupId"=>"EG001", "numAtRisk"=>422, "numAffected"=>0}, {"groupId"=>"EG002", "numAtRisk"=>171, "numAffected"=>1}, {"groupId"=>"EG003", "numAtRisk"=>61, "numAffected"=>0}], "organSystem"=>"Vascular disorders", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE (2.0)"}, {"term"=>"Skin", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>418, "numAffected"=>2}, {"groupId"=>"EG001", "numAtRisk"=>422, "numAffected"=>0}, {"groupId"=>"EG002", "numAtRisk"=>171, "numAffected"=>3}, {"groupId"=>"EG003", "numAtRisk"=>61, "numAffected"=>3}], "organSystem"=>"Skin and subcutaneous tissue disorders", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE (2.0)"}, {"term"=>"Neuro-sensory", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>418, "numAffected"=>0}, {"groupId"=>"EG001", "numAtRisk"=>422, "numAffected"=>1}, {"groupId"=>"EG002", "numAtRisk"=>171, "numAffected"=>3}, {"groupId"=>"EG003", "numAtRisk"=>61, "numAffected"=>0}], "organSystem"=>"Nervous system disorders", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE (2.0)"}, {"term"=>"Neuro-motor", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>418, "numAffected"=>6}, {"groupId"=>"EG001", "numAtRisk"=>422, "numAffected"=>0}, {"groupId"=>"EG002", "numAtRisk"=>171, "numAffected"=>1}, {"groupId"=>"EG003", "numAtRisk"=>61, "numAffected"=>4}], "organSystem"=>"Nervous system disorders", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE (2.0)"}, {"term"=>"Neuro-psych", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>418, "numAffected"=>1}, {"groupId"=>"EG001", "numAtRisk"=>422, "numAffected"=>0}, {"groupId"=>"EG002", "numAtRisk"=>171, "numAffected"=>3}, {"groupId"=>"EG003", "numAtRisk"=>61, "numAffected"=>1}], "organSystem"=>"Nervous system disorders", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE (2.0)"}, {"term"=>"Others", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>418, "numAffected"=>0}, {"groupId"=>"EG001", "numAtRisk"=>422, "numAffected"=>2}, {"groupId"=>"EG002", "numAtRisk"=>171, "numAffected"=>7}, {"groupId"=>"EG003", "numAtRisk"=>61, "numAffected"=>6}], "organSystem"=>"General disorders", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE (2.0)"}, {"term"=>"Alopecia", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>418, "numAffected"=>0}, {"groupId"=>"EG001", "numAtRisk"=>422, "numAffected"=>0}, {"groupId"=>"EG002", "numAtRisk"=>171, "numAffected"=>1}, {"groupId"=>"EG003", "numAtRisk"=>61, "numAffected"=>0}], "organSystem"=>"Skin and subcutaneous tissue disorders", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE (2.0)"}, {"term"=>"Phlebitis", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>418, "numAffected"=>0}, {"groupId"=>"EG001", "numAtRisk"=>422, "numAffected"=>0}, {"groupId"=>"EG002", "numAtRisk"=>171, "numAffected"=>5}, {"groupId"=>"EG003", "numAtRisk"=>61, "numAffected"=>2}], "organSystem"=>"Blood and lymphatic system disorders", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE (2.0)"}, {"term"=>"Neuro-clinical", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>418, "numAffected"=>0}, {"groupId"=>"EG001", "numAtRisk"=>422, "numAffected"=>0}, {"groupId"=>"EG002", "numAtRisk"=>171, "numAffected"=>6}, {"groupId"=>"EG003", "numAtRisk"=>61, "numAffected"=>3}], "organSystem"=>"Nervous system disorders", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE (2.0)"}], "frequencyThreshold"=>"5"}, "outcomeMeasuresModule"=>{"outcomeMeasures"=>[{"type"=>"PRIMARY", "title"=>"5-year Overall Survival Rate in Patients With Dukes' B3/C Disease", "denoms"=>[{"units"=>"Participants", "counts"=>[{"value"=>"156", "groupId"=>"OG000"}, {"value"=>"158", "groupId"=>"OG001"}]}], "groups"=>[{"id"=>"OG000", "title"=>"Perioperative 5-FU", "description"=>"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.\n\nAfter surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m\\^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m\\^2 IV push on days 1-5\n\nfluorouracil: Perioperative 5-FU: 600 mg/m\\^2/d x 7 days continuous IV, beginning within 24 hours of surgery\n\nAfter surgery, 5-FU was given 425 mg/m\\^2 IV push on days 1-5\n\nleucovorin calcium: given after surgery at dose of 20mg/m\\^2 IV push on days 1-5"}, {"id"=>"OG001", "title"=>"No Perioperative 5-FU", "description"=>"Patients receive no perioperative fluorouracil.\n\nAfter surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m\\^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m\\^2 IV push on days 1-5\n\nfluorouracil: Perioperative 5-FU: 600 mg/m\\^2/d x 7 days continuous IV, beginning within 24 hours of surgery\n\nAfter surgery, 5-FU was given 425 mg/m\\^2 IV push on days 1-5\n\nleucovorin calcium: given after surgery at dose of 20mg/m\\^2 IV push on days 1-5"}], "classes"=>[{"categories"=>[{"measurements"=>[{"value"=>"0.666", "groupId"=>"OG000", "lowerLimit"=>"0.585", "upperLimit"=>"0.735"}, {"value"=>"0.612", "groupId"=>"OG001", "lowerLimit"=>"0.530", "upperLimit"=>"0.683"}]}]}], "analyses"=>[{"pValue"=>"0.178", "groupIds"=>["OG000", "OG001"], "pValueComment"=>"one-sided log-rank test p value", "statisticalMethod"=>"Log Rank", "nonInferiorityType"=>"SUPERIORITY_OR_OTHER_LEGACY"}], "paramType"=>"NUMBER", "timeFrame"=>"every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization", "description"=>"Overall survival (OS) is defined as time from randomization to death from any cause or last date known alive. Kaplan-Meier method was used to estimate 5-year OS rate", "unitOfMeasure"=>"proportion of participants", "dispersionType"=>"95% Confidence Interval", "reportingStatus"=>"POSTED", "populationDescription"=>"All randomized patients with Dukes' B3 and C disease"}, {"type"=>"SECONDARY", "title"=>"5-year Disease-free Survival Rate in Patients With Dukes' B3/C Disease", "denoms"=>[{"units"=>"Participants", "counts"=>[{"value"=>"128", "groupId"=>"OG000"}, {"value"=>"131", "groupId"=>"OG001"}]}], "groups"=>[{"id"=>"OG000", "title"=>"Perioperative 5-FU", "description"=>"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.\n\nAfter surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m\\^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m\\^2 IV push on days 1-5\n\nfluorouracil: Perioperative 5-FU: 600 mg/m\\^2/d x 7 days continuous IV, beginning within 24 hours of surgery\n\nAfter surgery, 5-FU was given 425 mg/m\\^2 IV push on days 1-5\n\nleucovorin calcium: given after surgery at dose of 20mg/m\\^2 IV push on days 1-5"}, {"id"=>"OG001", "title"=>"No Perioperative 5-FU", "description"=>"Patients receive no perioperative fluorouracil.\n\nAfter surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m\\^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m\\^2 IV push on days 1-5\n\nfluorouracil: Perioperative 5-FU: 600 mg/m\\^2/d x 7 days continuous IV, beginning within 24 hours of surgery\n\nAfter surgery, 5-FU was given 425 mg/m\\^2 IV push on days 1-5\n\nleucovorin calcium: given after surgery at dose of 20mg/m\\^2 IV push on days 1-5"}], "classes"=>[{"categories"=>[{"measurements"=>[{"value"=>"0.582", "groupId"=>"OG000", "lowerLimit"=>"0.486", "upperLimit"=>"0.668"}, {"value"=>"0.543", "groupId"=>"OG001", "lowerLimit"=>"0.442", "upperLimit"=>"0.634"}]}]}], "analyses"=>[{"pValue"=>"0.847", "groupIds"=>["OG000", "OG001"], "pValueComment"=>"two-sided log rank test", "statisticalMethod"=>"Log Rank", "nonInferiorityType"=>"SUPERIORITY_OR_OTHER_LEGACY"}], "paramType"=>"NUMBER", "timeFrame"=>"every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization", "description"=>"Disease-free survival (DFS) was defined as time from randomization to recurrence, second invasive primary cancer, or deaths, whichever occurred first. Patients who were still alive and had no DFS events were censored at the last disease assessment date known to be free of DFS events. Patients without any follow up data were censored at random assignment. Kaplan-Meier method was used to estimate the 5-year DFS rate.", "unitOfMeasure"=>"proportion of participants", "dispersionType"=>"95% Confidence Interval", "reportingStatus"=>"POSTED", "populationDescription"=>"All randomized patients with Dukes' B3 and C disease who had complete disease assessment data"}, {"type"=>"SECONDARY", "title"=>"5-year Overall Survival Rate in Patients With Dukes' B2 Disease", "denoms"=>[{"units"=>"Participants", "counts"=>[{"value"=>"150", "groupId"=>"OG000"}, {"value"=>"139", "groupId"=>"OG001"}]}], "groups"=>[{"id"=>"OG000", "title"=>"Perioperative 5-FU", "description"=>"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.\n\nAfter surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m\\^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m\\^2 IV push on days 1-5\n\nfluorouracil: Perioperative 5-FU: 600 mg/m\\^2/d x 7 days continuous IV, beginning within 24 hours of surgery\n\nAfter surgery, 5-FU was given 425 mg/m\\^2 IV push on days 1-5\n\nleucovorin calcium: given after surgery at dose of 20mg/m\\^2 IV push on days 1-5"}, {"id"=>"OG001", "title"=>"No Perioperative 5-FU", "description"=>"Patients receive no perioperative fluorouracil.\n\nAfter surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m\\^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m\\^2 IV push on days 1-5\n\nfluorouracil: Perioperative 5-FU: 600 mg/m\\^2/d x 7 days continuous IV, beginning within 24 hours of surgery\n\nAfter surgery, 5-FU was given 425 mg/m\\^2 IV push on days 1-5\n\nleucovorin calcium: given after surgery at dose of 20mg/m\\^2 IV push on days 1-5"}], "classes"=>[{"categories"=>[{"measurements"=>[{"value"=>"0.851", "groupId"=>"OG000", "lowerLimit"=>"0.783", "upperLimit"=>"0.899"}, {"value"=>"0.780", "groupId"=>"OG001", "lowerLimit"=>"0.701", "upperLimit"=>"0.841"}]}]}], "paramType"=>"NUMBER", "timeFrame"=>"every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization", "description"=>"Overall survival (OS) is defined as time from randomization to death from any cause or last date known alive. Kaplan-Meier method was used to estimate 5-year OS rate", "unitOfMeasure"=>"proportion of participants", "dispersionType"=>"95% Confidence Interval", "reportingStatus"=>"POSTED", "populationDescription"=>"All randomized patients with Dukes' B2 disease"}, {"type"=>"SECONDARY", "title"=>"5-year Disease-free Survival Rate in Patients With Dukes' B2 Disease", "denoms"=>[{"units"=>"Participants", "counts"=>[{"value"=>"133", "groupId"=>"OG000"}, {"value"=>"123", "groupId"=>"OG001"}]}], "groups"=>[{"id"=>"OG000", "title"=>"Perioperative 5-FU", "description"=>"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.\n\nAfter surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m\\^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m\\^2 IV push on days 1-5\n\nfluorouracil: Perioperative 5-FU: 600 mg/m\\^2/d x 7 days continuous IV, beginning within 24 hours of surgery\n\nAfter surgery, 5-FU was given 425 mg/m\\^2 IV push on days 1-5\n\nleucovorin calcium: given after surgery at dose of 20mg/m\\^2 IV push on days 1-5"}, {"id"=>"OG001", "title"=>"No Perioperative 5-FU", "description"=>"Patients receive no perioperative fluorouracil.\n\nAfter surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m\\^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m\\^2 IV push on days 1-5\n\nfluorouracil: Perioperative 5-FU: 600 mg/m\\^2/d x 7 days continuous IV, beginning within 24 hours of surgery\n\nAfter surgery, 5-FU was given 425 mg/m\\^2 IV push on days 1-5\n\nleucovorin calcium: given after surgery at dose of 20mg/m\\^2 IV push on days 1-5"}], "classes"=>[{"categories"=>[{"measurements"=>[{"value"=>"0.749", "groupId"=>"OG000", "lowerLimit"=>"0.660", "upperLimit"=>"0.818"}, {"value"=>"0.724", "groupId"=>"OG001", "lowerLimit"=>"0.626", "upperLimit"=>"0.801"}]}]}], "paramType"=>"NUMBER", "timeFrame"=>"every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization", "description"=>"Disease-free survival (DFS) was defined as time from randomization to recurrence, second invasive primary cancer, or deaths, whichever occurred first. Patients who were still alive and had no DFS events were censored at the last disease assessment date known to be free of DFS events. Patients without any follow up data were censored at random assignment. Kaplan-Meier method was used to estimate the 5-year DFS rate.", "unitOfMeasure"=>"proportion of participants", "dispersionType"=>"95% Confidence Interval", "reportingStatus"=>"POSTED", "populationDescription"=>"All randomized patients with Dukes' B2 disease who had complete disease assessment data"}]}, "participantFlowModule"=>{"groups"=>[{"id"=>"FG000", "title"=>"Perioperative 5-FU", "description"=>"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.\n\nAfter surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m\\^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m\\^2 IV push on days 1-5\n\nfluorouracil: Perioperative 5-FU: 600 mg/m\\^2/d x 7 days continuous IV, beginning within 24 hours of surgery\n\nAfter surgery, 5-FU was given 425 mg/m\\^2 IV push on days 1-5\n\nleucovorin calcium: given after surgery at dose of 20mg/m\\^2 IV push on days 1-5"}, {"id"=>"FG001", "title"=>"No Perioperative 5-FU", "description"=>"Patients receive no perioperative fluorouracil.\n\nAfter surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m\\^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m\\^2 IV push on days 1-5 fluorouracil: Perioperative 5-FU: 600 mg/m\\^2/d x 7 days continuous IV, beginning within 24 hours of surgery After surgery, 5-FU was given 425 mg/m\\^2 IV push on days 1-5 leucovorin calcium: given after surgery at dose of 20mg/m\\^2 IV push on days 1-5"}], "periods"=>[{"title"=>"Overall Study", "milestones"=>[{"type"=>"STARTED", "achievements"=>[{"comment"=>"859 patients were enrolled to the study, but 4 patients were not randomized to any treatment arm", "groupId"=>"FG000", "numSubjects"=>"427"}, {"groupId"=>"FG001", "numSubjects"=>"428"}]}, {"type"=>"Treated", "achievements"=>[{"groupId"=>"FG000", "numSubjects"=>"419"}, {"comment"=>"Patients on \"No perioperative 5-FU arm\" received no perioperative chemotherapy", "groupId"=>"FG001", "numSubjects"=>"0"}]}, {"type"=>"Dukes' B3 or C Stage", "achievements"=>[{"comment"=>"Primary population: pts with Duke's B3, C disease. 158 such pts on \"No perioperative 5-FU arm\"", "groupId"=>"FG000", "numSubjects"=>"156"}, {"groupId"=>"FG001", "numSubjects"=>"158"}]}, {"type"=>"Dukes' B2 Stage", "achievements"=>[{"groupId"=>"FG000", "numSubjects"=>"150"}, {"groupId"=>"FG001", "numSubjects"=>"139"}]}, {"type"=>"COMPLETED", "achievements"=>[{"groupId"=>"FG000", "numSubjects"=>"241"}, {"comment"=>"Patients on \"No perioperative 5-FU arm\" received no perioperative chemotherapy", "groupId"=>"FG001", "numSubjects"=>"428"}]}, {"type"=>"NOT COMPLETED", "achievements"=>[{"groupId"=>"FG000", "numSubjects"=>"186"}, {"groupId"=>"FG001", "numSubjects"=>"0"}]}], "dropWithdraws"=>[{"type"=>"Adverse Event", "reasons"=>[{"groupId"=>"FG000", "numSubjects"=>"36"}, {"groupId"=>"FG001", "numSubjects"=>"0"}]}, {"type"=>"Death", "reasons"=>[{"groupId"=>"FG000", "numSubjects"=>"5"}, {"groupId"=>"FG001", "numSubjects"=>"0"}]}, {"type"=>"Withdrawal by Subject", "reasons"=>[{"groupId"=>"FG000", "numSubjects"=>"11"}, {"groupId"=>"FG001", "numSubjects"=>"0"}]}, {"type"=>"Start non-protocol therapy", "reasons"=>[{"groupId"=>"FG000", "numSubjects"=>"1"}, {"groupId"=>"FG001", "numSubjects"=>"0"}]}, {"type"=>"Other complicating disease", "reasons"=>[{"groupId"=>"FG000", "numSubjects"=>"1"}, {"groupId"=>"FG001", "numSubjects"=>"0"}]}, {"type"=>"Duke's A, B1, D disease", "reasons"=>[{"groupId"=>"FG000", "numSubjects"=>"92"}, {"groupId"=>"FG001", "numSubjects"=>"0"}]}, {"type"=>"Error", "reasons"=>[{"groupId"=>"FG000", "numSubjects"=>"6"}, {"groupId"=>"FG001", "numSubjects"=>"0"}]}, {"type"=>"Other", "reasons"=>[{"groupId"=>"FG000", "numSubjects"=>"26"}, {"groupId"=>"FG001", "numSubjects"=>"0"}]}, {"type"=>"Never start protocol therapy", "reasons"=>[{"groupId"=>"FG000", "numSubjects"=>"8"}, {"groupId"=>"FG001", "numSubjects"=>"0"}]}]}], "recruitmentDetails"=>"This study was activated on August 20, 1993 and was terminated on May 19, 2000 before reaching its accrual goal due slow accrual. The first accrual was on October 1, 1993. The final accrual for the study was 859 patients."}, "baselineCharacteristicsModule"=>{"denoms"=>[{"units"=>"Participants", "counts"=>[{"value"=>"156", "groupId"=>"BG000"}, {"value"=>"158", "groupId"=>"BG001"}, {"value"=>"314", "groupId"=>"BG002"}]}], "groups"=>[{"id"=>"BG000", "title"=>"Perioperative 5-FU", "description"=>"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.\n\nAfter surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m\\^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m\\^2 IV push on days 1-5\n\nfluorouracil: Perioperative 5-FU: 600 mg/m\\^2/d x 7 days continuous IV, beginning within 24 hours of surgery\n\nAfter surgery, 5-FU was given 425 mg/m\\^2 IV push on days 1-5\n\nleucovorin calcium: given after surgery at dose of 20mg/m\\^2 IV push on days 1-5"}, {"id"=>"BG001", "title"=>"No Perioperative 5-FU", "description"=>"Patients receive no perioperative fluorouracil.\n\nAfter surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m\\^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m\\^2 IV push on days 1-5\n\nfluorouracil: Perioperative 5-FU: 600 mg/m\\^2/d x 7 days continuous IV, beginning within 24 hours of surgery\n\nAfter surgery, 5-FU was given 425 mg/m\\^2 IV push on days 1-5\n\nleucovorin calcium: given after surgery at dose of 20mg/m\\^2 IV push on days 1-5"}, {"id"=>"BG002", "title"=>"Total", "description"=>"Total of all reporting groups"}], "measures"=>[{"title"=>"Age, Continuous", "classes"=>[{"categories"=>[{"measurements"=>[{"value"=>"63", "groupId"=>"BG000", "lowerLimit"=>"30", "upperLimit"=>"89"}, {"value"=>"66", "groupId"=>"BG001", "lowerLimit"=>"25", "upperLimit"=>"86"}, {"value"=>"65", "groupId"=>"BG002", "lowerLimit"=>"25", "upperLimit"=>"89"}]}]}], "paramType"=>"MEDIAN", "unitOfMeasure"=>"Years", "dispersionType"=>"FULL_RANGE"}, {"title"=>"Sex/Gender, Customized", "classes"=>[{"title"=>"Female", "categories"=>[{"measurements"=>[{"value"=>"57", "groupId"=>"BG000"}, {"value"=>"61", "groupId"=>"BG001"}, {"value"=>"118", "groupId"=>"BG002"}]}]}, {"title"=>"Male", "categories"=>[{"measurements"=>[{"value"=>"99", "groupId"=>"BG000"}, {"value"=>"96", "groupId"=>"BG001"}, {"value"=>"195", "groupId"=>"BG002"}]}]}], "paramType"=>"NUMBER", "description"=>"1 patient on \"No perioperative 5-FU arm\" had missing information about sex", "unitOfMeasure"=>"participants"}], "populationDescription"=>"The primary analysis population for the study was all randomized patients with Duke's B3 and C disease."}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>859}}, "statusModule"=>{"whyStopped"=>"The study was stopped before reaching its accrual goal due to slow accrual", "overallStatus"=>"TERMINATED", "startDateStruct"=>{"date"=>"1993-10-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2023-06", "completionDateStruct"=>{"date"=>"2015-04", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2023-06-13", "studyFirstSubmitDate"=>"1999-11-01", "resultsFirstSubmitDate"=>"2016-04-08", "studyFirstSubmitQcDate"=>"2004-04-05", "lastUpdatePostDateStruct"=>{"date"=>"2023-06-28", "type"=>"ACTUAL"}, "resultsFirstSubmitQcDate"=>"2016-06-08", "studyFirstPostDateStruct"=>{"date"=>"2004-04-06", "type"=>"ESTIMATED"}, "resultsFirstPostDateStruct"=>{"date"=>"2016-07-20", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"2015-02", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"5-year Overall Survival Rate in Patients With Dukes' B3/C Disease", "timeFrame"=>"every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization", "description"=>"Overall survival (OS) is defined as time from randomization to death from any cause or last date known alive. Kaplan-Meier method was used to estimate 5-year OS rate"}], "secondaryOutcomes"=>[{"measure"=>"5-year Disease-free Survival Rate in Patients With Dukes' B3/C Disease", "timeFrame"=>"every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization", "description"=>"Disease-free survival (DFS) was defined as time from randomization to recurrence, second invasive primary cancer, or deaths, whichever occurred first. Patients who were still alive and had no DFS events were censored at the last disease assessment date known to be free of DFS events. Patients without any follow up data were censored at random assignment. Kaplan-Meier method was used to estimate the 5-year DFS rate."}, {"measure"=>"5-year Overall Survival Rate in Patients With Dukes' B2 Disease", "timeFrame"=>"every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization", "description"=>"Overall survival (OS) is defined as time from randomization to death from any cause or last date known alive. Kaplan-Meier method was used to estimate 5-year OS rate"}, {"measure"=>"5-year Disease-free Survival Rate in Patients With Dukes' B2 Disease", "timeFrame"=>"every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization", "description"=>"Disease-free survival (DFS) was defined as time from randomization to recurrence, second invasive primary cancer, or deaths, whichever occurred first. Patients who were still alive and had no DFS events were censored at the last disease assessment date known to be free of DFS events. Patients without any follow up data were censored at random assignment. Kaplan-Meier method was used to estimate the 5-year DFS rate."}]}, "oversightModule"=>{"oversightHasDmc"=>true}, "conditionsModule"=>{"keywords"=>["stage II colon cancer", "stage III colon cancer"], "conditions"=>["Colorectal Cancer"]}, "referencesModule"=>{"references"=>[{"type"=>"RESULT", "citation"=>"Kemeny M, Ibrahim J, Benson AB, et al.: Post-operative complications of continuous infusion 5 FU following curative resection of colon cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 16: A923, 260a, 1997."}]}, "descriptionModule"=>{"briefSummary"=>"RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells. It is not yet known if surgery is more effective with or without chemotherapy for colon cancer.\n\nPURPOSE: Randomized phase III trial to evaluate whether perioperative 5-Fluorouracil (5-FU) chemotherapy after curative resection could improve overall survival and disease-free survival in patients with Duke's B3 or C colon cancer.", "detailedDescription"=>"OBJECTIVES:\n\nI. To determine if adjuvant therapy with one week of continuous 5-FU given within 24 hours of a curative colon resection followed by 6 months of 5-FU/leucovorin is effective in prolonging the disease-free survival and increasing overall survival in patients with Dukes' B3 or C colon cancer, when compared to patients who are treated with 5-FU/leucovorin only.\n\nII. 1. To determine if a week of perioperative continuous 5-FU affects disease-free survival and overall survival in patients with Dukes' B2 colon cancer.\n\nOUTLINE: This is an open-label, randomized phase III study. Patients undergo curative colon resection via laparotomy. Patients are randomized to 1 of 2 arms in a 1:1 ratio.\n\nArm I (Perioperative 5-FU): Within 24 hours of the colon resection, patients receive perioperative 5-fluorouracil (5-FU) intravenously (IV) over 24 hours for 7 days.\n\nArm II (No perioperative 5-FU): Patients receive no perioperative fluorouracil.\n\nAfter surgery, patients with stage I, stage IIA, or stage IV colon cancer are immediately removed from study. Patients with stage IIB, IIC, or III colon cancer are re-registered within 35 days postoperatively. Beginning 21-35 days after surgery, patients with stage IIC or III disease receive leucovorin calcium IV bolus immediately followed by 5-FU IV bolus on days 1-5. Courses repeat every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stage IIB disease do not receive adjuvant 5-FU and leucovorin calcium.\n\nPatients are followed every 3 months for 2 years, then every 6 months for 2 years, and then annually until 15 years.\n\nPROJECTED ACCRUAL: A total of 800-2,000 patients (at least 400 per treatment arm) will be accrued for this study over 2-3 years."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Eligibility Criteria for Randomization:\n\nInclusion Criteria:\n\n* Adenocarcinoma of the colon documented by colonoscopy or barium enema\n* Tumor either considered resectable or totally resected within 24 hours prior to study\n* Randomization within 2 weeks prior to surgery or within 24 hours after surgery required\n* Patients randomized after surgery must meet the following criteria:\n\n * Complete resection performed with no evidence of residual disease or distant metastases\n * Distal margin of tumor above the peritoneal reflection in area of rectum\n * No free perforation Intestinal obstruction allowed\n * Preliminary or complementary colostomy allowed\n* Concurrent registration for E3293 strongly recommended\n* Age 18 and over\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Adequate organ function based on the following tests within 2 weeks prior to randomization\n\n * White Blood Cell (WBC) at least 3,000/mm\\^3\n * Platelet count at least 100,000/mm\\^3\n * Bilirubin no greater than 2.0 mg/dL\n * Creatinine no greater than 2.0 mg/dL\n* No second malignancy within 5 years except: superficial non-melanomatous skin cancer and carcinoma in situ of the cervix\n* Fertile patients must use adequate contraception\n\nExclusion Criteria:\n\n* Dual primary tumors\n* Prior nonmalignant systemic disease that would preclude use of chemotherapy\n* Pregnant or nursing\n* Prior fluorouracil\n* Other prior or concurrent chemotherapy for this malignancy\n* Prior or concurrent radiotherapy for this malignancy\n\nEligibility Criteria for Re-registration for Patients Randomized Pre-operatively:\n\n* Must have pathologic classification of Dukes' B2, B3, or C disease by the contributing institution.\n* Must be re-registered \\< 35 days after surgery.\n* ECOG performance status of 0-2.\n* Complete resection must have been performed with no evidence of residual disease or distant metastasis.\n* Distal margin of the tumor must not extend below the peritoneal reflection in the area of the rectum.\n* Single primary colon carcinoma without free perforation demonstrated. Patients with intestinal obstruction are eligible. Preliminary or complementary colostomy dose not preclude entry of a patient.\n* Have WBC \\> 3000/mm\\^3, platelets \\> 100,000/mm\\^3, adequate renal (serum creatinine \\<= 2.0mg/dL) and hepatic function (bilirubin \\<= 2.0mg/dL), within one week prior to beginning adjuvant chemotherapy (For Dukes' B3 and C patients only).\n\nEligibility Criteria for Re-registration for Patients Randomized Post-operatively:\n\n* Must have pathologic classification of Dukes' B2, B3, or C disease by the contributing institution.\n* Patient must be re-registered \\< 35 days after surgery.\n* ECOG performance status of 0-2.\n* Started perioperative 5-FU, if assigned, within 24 hours of surgery.\n* Have WBC \\> 3000/mm\\^3, platelets \\> 100,000/mm\\^3, adequate renal (serum creatinine \\<= 2.0mg/dL) and hepatic function (bilirubin \\< =2.0mg/dL), within one week prior to beginning adjuvant chemotherapy (For Dukes' B3 and C patients only)."}, "identificationModule"=>{"nctId"=>"NCT00002525", "briefTitle"=>"Perioperative Chemotherapy in Treating Patients With Colon Cancer That Can Be Surgically Removed", "organization"=>{"class"=>"NETWORK", "fullName"=>"Eastern Cooperative Oncology Group"}, "officialTitle"=>"Phase III Intergroup Prospectively Randomized Trial of Perioperative 5-FU After Curative Resection, Followed by 5-FU/Leucovorin for Patients With Colon Cancer", "orgStudyIdInfo"=>{"id"=>"E1292"}, "secondaryIdInfos"=>[{"id"=>"E1292", "type"=>"OTHER", "domain"=>"ECOG-ACRIN Cancer Research Group"}, {"id"=>"U10CA023318", "link"=>"https://reporter.nih.gov/quickSearch/U10CA023318", "type"=>"NIH"}, {"id"=>"CDR0000078337", "type"=>"REGISTRY", "domain"=>"CTRP (Clinical Trial Reporting Program)"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Perioperative 5-FU", "description"=>"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.\n\nAfter surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m\\^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m\\^2 IV push on days 1-5", "interventionNames"=>["Drug: fluorouracil", "Drug: leucovorin calcium"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"No perioperative 5-FU", "description"=>"Patients receive no perioperative fluorouracil.\n\nAfter surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m\\^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m\\^2 IV push on days 1-5", "interventionNames"=>["Drug: fluorouracil", "Drug: leucovorin calcium"]}], "interventions"=>[{"name"=>"fluorouracil", "type"=>"DRUG", "otherNames"=>["5-FU", "Adrucil", "Efudex"], "description"=>"Perioperative 5-FU: 600 mg/m\\^2/d x 7 days continuous IV, beginning within 24 hours of surgery\n\nAfter surgery, 5-FU was given 425 mg/m\\^2 IV push on days 1-5", "armGroupLabels"=>["No perioperative 5-FU", "Perioperative 5-FU"]}, {"name"=>"leucovorin calcium", "type"=>"DRUG", "otherNames"=>["Leucovorin", "Wellcovorin", "Citrovorum factor", "Folinic acid", "5-formyl tetrahydrofolate", "LV", "LCV"], "description"=>"given after surgery at dose of 20mg/m\\^2 IV push on days 1-5", "armGroupLabels"=>["No perioperative 5-FU", "Perioperative 5-FU"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"60153", "city"=>"Maywood", "state"=>"Illinois", "country"=>"United States", "facility"=>"Loyola University Medical Center", "geoPoint"=>{"lat"=>41.8792, "lon"=>-87.84312}}], "overallOfficials"=>[{"name"=>"Mary M. Kemeny, MD, FACS", "role"=>"STUDY_CHAIR", "affiliation"=>"SUNY at Stony Brook"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"YES", "description"=>"Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"ECOG-ACRIN Cancer Research Group", "class"=>"NETWORK"}, "collaborators"=>[{"name"=>"National Cancer Institute (NCI)", "class"=>"NIH"}, {"name"=>"SWOG Cancer Research Network", "class"=>"NETWORK"}, {"name"=>"Cancer and Leukemia Group B", "class"=>"NETWORK"}, {"name"=>"American College of Surgeons", "class"=>"OTHER"}, {"name"=>"NSABP Foundation Inc", "class"=>"NETWORK"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}