Nctid:
NCT00002527
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D015179", "term"=>"Colorectal Neoplasms"}], "ancestors"=>[{"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"}, {"id"=>"D012002", "term"=>"Rectal Diseases"}], "browseLeaves"=>[{"id"=>"M3591", "name"=>"Adenoma", "relevance"=>"LOW"}, {"id"=>"M17890", "name"=>"Colorectal Neoplasms", "asFound"=>"Colorectal Cancer", "relevance"=>"HIGH"}, {"id"=>"M10448", "name"=>"Intestinal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8886", "name"=>"Gastrointestinal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M7256", "name"=>"Digestive System 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"}, {"id"=>"M14844", "name"=>"Rectal Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D001241", "term"=>"Aspirin"}], "ancestors"=>[{"id"=>"D000894", "term"=>"Anti-Inflammatory Agents, Non-Steroidal"}, {"id"=>"D018712", "term"=>"Analgesics, Non-Narcotic"}, {"id"=>"D000700", "term"=>"Analgesics"}, {"id"=>"D018689", "term"=>"Sensory System Agents"}, {"id"=>"D018373", "term"=>"Peripheral Nervous System Agents"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000893", "term"=>"Anti-Inflammatory Agents"}, {"id"=>"D018501", "term"=>"Antirheumatic Agents"}, {"id"=>"D005343", "term"=>"Fibrinolytic Agents"}, {"id"=>"D050299", "term"=>"Fibrin Modulating Agents"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D010975", "term"=>"Platelet Aggregation Inhibitors"}, {"id"=>"D016861", "term"=>"Cyclooxygenase Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D058633", "term"=>"Antipyretics"}], "browseLeaves"=>[{"id"=>"M4548", "name"=>"Aspirin", "asFound"=>"Volunteers", "relevance"=>"HIGH"}, {"id"=>"M4217", "name"=>"Anti-Inflammatory Agents", "relevance"=>"LOW"}, {"id"=>"M4218", "name"=>"Anti-Inflammatory Agents, Non-Steroidal", "relevance"=>"LOW"}, {"id"=>"M4032", "name"=>"Analgesics", "relevance"=>"LOW"}, {"id"=>"M20786", "name"=>"Analgesics, Non-Narcotic", "relevance"=>"LOW"}, {"id"=>"M20604", "name"=>"Antirheumatic Agents", "relevance"=>"LOW"}, {"id"=>"M8473", "name"=>"Fibrinolytic Agents", "relevance"=>"LOW"}, {"id"=>"M13865", "name"=>"Platelet Aggregation Inhibitors", "relevance"=>"LOW"}, {"id"=>"M19209", "name"=>"Cyclooxygenase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M29176", "name"=>"Antipyretics", "relevance"=>"LOW"}, {"id"=>"T120", "name"=>"Cola", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antipyretics", "abbrev"=>"Antipy"}, {"name"=>"Anti-Inflammatory Agents", "abbrev"=>"Infl"}, {"name"=>"Antirheumatic Agents", "abbrev"=>"ARhu"}, {"name"=>"Fibrinolytic Agents", "abbrev"=>"FiAg"}, {"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"Platelet Aggregation Inhibitors", "abbrev"=>"PlAggInh"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Herbal and Botanical", "abbrev"=>"HB"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"TRIPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR"]}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>635}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1993-05"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2016-07", "completionDateStruct"=>{"date"=>"2006-01", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2016-07-01", "studyFirstSubmitDate"=>"1999-11-01", "studyFirstSubmitQcDate"=>"2004-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2016-07-04", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2004-08-31", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"2003-03", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Reduction in size of tumors", "timeFrame"=>"Up to 4 years"}, {"measure"=>"Reduction in number of tumors", "timeFrame"=>"Up to 4 years"}, {"measure"=>"Disease free survival", "timeFrame"=>"Up to 4 years"}]}, "oversightModule"=>{"oversightHasDmc"=>true}, "conditionsModule"=>{"keywords"=>["colon cancer", "rectal cancer"], "conditions"=>["Colorectal Cancer"]}, "referencesModule"=>{"references"=>[{"pmid"=>"12621132", "type"=>"RESULT", "citation"=>"Sandler RS, Halabi S, Baron JA, Budinger S, Paskett E, Keresztes R, Petrelli N, Pipas JM, Karp DD, Loprinzi CL, Steinbach G, Schilsky R. A randomized trial of aspirin to prevent colorectal adenomas in patients with previous colorectal cancer. N Engl J Med. 2003 Mar 6;348(10):883-90. doi: 10.1056/NEJMoa021633. Erratum In: N Engl J Med. 2003 May 8;348(19):1939."}]}, "descriptionModule"=>{"briefSummary"=>"RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of aspirin may be an effective way to prevent the recurrence of polyps in colorectal cancer.\n\nPURPOSE: Randomized phase III trial to study the effectiveness of aspirin in treating patients who have stage I, stage II, or stage III colorectal cancer that has been surgically removed.", "detailedDescription"=>"OBJECTIVES: I. Determine whether aspirin administered at a dose of 325 mg/day will decrease the number and size of new adenomas in patients with Dukes' A/B1/B2/C colorectal cancer who have undergone curative surgical resection. II. Assess whether this dose of aspirin will increase disease-free survival in these patients.\n\nOUTLINE: Randomized, double-blind study. Arm I: Chemoprevention. Enteric-coated Aspirin, ASA, NSC-27223. Arm II: Control. Placebo, PLCB."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"74 years", "minimumAge"=>"30 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS: Histologically documented colorectal cancer that has been curatively resected, including: Dukes' A/B1 (T1-2, N0, M0) Dukes' B2/C (T3, N0, M0 and any T, N1, M0) disease-free more than 5 years post-resection Colonoscopy to the cecum (or small bowel anastomosis) with removal of all polyps required within 4 months of entry Preparation must be adequate to visualize mucosa and discern the presence of no further polyps No familial polyposis (more than 100 polyps at time of resection) No history of inflammatory bowel disease including ulcerative colitis or Crohn's disease\n\nPATIENT CHARACTERISTICS: Age: 30 to under 75 Performance status: Physician's assessment of good general health required Life expectancy: At least 5 years Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No NYHA class III/IV status No history of angina No history of MI No history of stroke or TIAs No peripheral vascular disease No bleeding diathesis including hemorrhagic stroke No prophylactic aspirin for cardiovascular disease Other: No documented peptic ulcer disease within past 15 years No aspirin sensitivity including: Aspirin-induced asthma Bronchial hyper-reactivity Urticaria Angioedema No requirement for sodium warfarin or other anticoagulant No frequent (greater than 36 times/year) NSAID use within the past 5 years No recurrent arthritis or other musculoskeletal problems No narcotic or alcohol dependency (unless there has been at least a 6-month period of abstinence) No prior or concurrent malignancy within 5 years (including metastases) except nonmelanomatous skin cancer No pregnant or nursing women Effective contraception required of fertile women\n\nPRIOR CONCURRENT THERAPY: No concurrent enrollment in a colon cancer treatment trial or other chemoprevention trial Biologic therapy: At least 6 months since immunosuppressive therapy (i.e., azathioprine, methotrexate, cyclosporine) Chemotherapy: Prior chemotherapy allowed for patients with Dukes' B2/C colorectal cancer No concurrent chemotherapy Endocrine therapy: Prior non-immunosuppressive steroid treatment allowed Radiotherapy: Prior radiotherapy allowed for patients with Dukes' B2/C colorectal cancer No concurrent radiotherapy Surgery: Curative resection required"}, "identificationModule"=>{"nctId"=>"NCT00002527", "briefTitle"=>"Aspirin in Treating Patients With Colorectal Cancer That Has Been Surgically Removed", "organization"=>{"class"=>"OTHER", "fullName"=>"Alliance for Clinical Trials in Oncology"}, "officialTitle"=>"Colorectal Adenoma Chemoprevention Trial Using Aspirin: A Phase III Study", "orgStudyIdInfo"=>{"id"=>"CALGB-9270"}, "secondaryIdInfos"=>[{"id"=>"CLB-9270"}, {"id"=>"E-C9270"}, {"id"=>"NCCTG-949251"}, {"id"=>"NCI-P93-0048"}, {"id"=>"CDR0000078380", "type"=>"REGISTRY", "domain"=>"NCI Physician Data Query"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Aspirin", "description"=>"325 mg/day PO", "interventionNames"=>["Drug: aspirin"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Placebo", "interventionNames"=>["Other: placebo"]}], "interventions"=>[{"name"=>"aspirin", "type"=>"DRUG", "armGroupLabels"=>["Aspirin"]}, {"name"=>"placebo", "type"=>"OTHER", "armGroupLabels"=>["Placebo"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"85259-5404", "city"=>"Scottsdale", "state"=>"Arizona", "country"=>"United States", "facility"=>"CCOP - Scottsdale Oncology Program", "geoPoint"=>{"lat"=>33.50921, "lon"=>-111.89903}}, {"zip"=>"94115-0128", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"UCSF Cancer Center and Cancer Research Institute", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"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"=>"61602", "city"=>"Peoria", "state"=>"Illinois", "country"=>"United States", "facility"=>"CCOP - Illinois Oncology Research Association", "geoPoint"=>{"lat"=>40.69365, "lon"=>-89.58899}}, {"zip"=>"61801", "city"=>"Urbana", "state"=>"Illinois", "country"=>"United States", "facility"=>"CCOP - Carle Cancer Center", "geoPoint"=>{"lat"=>40.11059, "lon"=>-88.20727}}, {"zip"=>"52403-1206", "city"=>"Cedar Rapids", "state"=>"Iowa", "country"=>"United States", "facility"=>"CCOP - Cedar Rapids Oncology Project", "geoPoint"=>{"lat"=>42.00833, "lon"=>-91.64407}}, {"zip"=>"10309-1016", "city"=>"Des Moines", "state"=>"Iowa", "country"=>"United States", "facility"=>"CCOP - Iowa Oncology Research Association", "geoPoint"=>{"lat"=>41.60054, "lon"=>-93.60911}}, {"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"=>"51101-1733", "city"=>"Sioux City", "state"=>"Iowa", "country"=>"United States", "facility"=>"Siouxland Hematology-Oncology", "geoPoint"=>{"lat"=>42.49999, "lon"=>-96.40031}}, {"zip"=>"70121", "city"=>"New Orleans", "state"=>"Louisiana", "country"=>"United States", "facility"=>"CCOP - Ochsner", "geoPoint"=>{"lat"=>29.95465, "lon"=>-90.07507}}, {"zip"=>"21201", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Marlene & Stewart Greenebaum Cancer Center, University of Maryland", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"zip"=>"02114", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Massachusetts General Hospital Cancer Center", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"01655", "city"=>"Worcester", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"University of Massachusetts Memorial Medical Center", "geoPoint"=>{"lat"=>42.26259, "lon"=>-71.80229}}, {"zip"=>"48106", "city"=>"Ann Arbor", "state"=>"Michigan", "country"=>"United States", "facility"=>"CCOP - Ann Arbor Regional", "geoPoint"=>{"lat"=>42.27756, "lon"=>-83.74088}}, {"zip"=>"55455", "city"=>"Minneapolis", "state"=>"Minnesota", "country"=>"United States", "facility"=>"University of Minnesota Cancer Center", "geoPoint"=>{"lat"=>44.97997, "lon"=>-93.26384}}, {"zip"=>"55905", "city"=>"Rochester", "state"=>"Minnesota", "country"=>"United States", "facility"=>"Mayo Clinic Cancer Center", "geoPoint"=>{"lat"=>44.02163, "lon"=>-92.4699}}, {"zip"=>"56303", "city"=>"Saint Cloud", "state"=>"Minnesota", "country"=>"United States", "facility"=>"CentraCare Clinic", "geoPoint"=>{"lat"=>45.5608, "lon"=>-94.16249}}, {"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"=>"68131", "city"=>"Omaha", "state"=>"Nebraska", "country"=>"United States", "facility"=>"CCOP - Missouri Valley Cancer Consortium", "geoPoint"=>{"lat"=>41.25626, "lon"=>-95.94043}}, {"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"=>"10021", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"New York Presbyterian Hospital - Cornell Campus", "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"=>"27599-7295", "city"=>"Chapel Hill", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Lineberger Comprehensive Cancer Center, UNC", "geoPoint"=>{"lat"=>35.9132, "lon"=>-79.05584}}, {"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"=>"58501", "city"=>"Bismarck", "state"=>"North Dakota", "country"=>"United States", "facility"=>"Quain & Ramstad Clinic, P.C.", "geoPoint"=>{"lat"=>46.80833, "lon"=>-100.78374}}, {"zip"=>"58122", "city"=>"Fargo", "state"=>"North Dakota", "country"=>"United States", "facility"=>"CCOP - Merit Care Hospital", "geoPoint"=>{"lat"=>46.87719, "lon"=>-96.7898}}, {"zip"=>"58201", "city"=>"Grand Forks", "state"=>"North Dakota", "country"=>"United States", "facility"=>"Altru Health Systems", "geoPoint"=>{"lat"=>47.92526, "lon"=>-97.03285}}, {"zip"=>"43623-3456", "city"=>"Toledo", "state"=>"Ohio", "country"=>"United States", "facility"=>"CCOP - Toledo Community Hospital Oncology Program", "geoPoint"=>{"lat"=>41.66394, "lon"=>-83.55521}}, {"zip"=>"17822-2001", "city"=>"Danville", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"CCOP - Geisinger Clinical and Medical Center", "geoPoint"=>{"lat"=>40.96342, "lon"=>-76.61273}}, {"zip"=>"02903", "city"=>"Providence", "state"=>"Rhode Island", "country"=>"United States", "facility"=>"Rhode Island Hospital", "geoPoint"=>{"lat"=>41.82399, "lon"=>-71.41283}}, {"zip"=>"57709", "city"=>"Rapid City", "state"=>"South Dakota", "country"=>"United States", "facility"=>"Rapid City Regional Hospital", "geoPoint"=>{"lat"=>44.08054, "lon"=>-103.23101}}, {"zip"=>"57105-1080", "city"=>"Sioux Falls", "state"=>"South Dakota", "country"=>"United States", "facility"=>"CCOP - Sioux Community Cancer Consortium", "geoPoint"=>{"lat"=>43.54997, "lon"=>-96.70033}}, {"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}}, {"zip"=>"S4S 6X3", "city"=>"Regina", "state"=>"Saskatchewan", "country"=>"Canada", "facility"=>"Saskatchewan Cancer Agency", "geoPoint"=>{"lat"=>50.45008, "lon"=>-104.6178}}], "overallOfficials"=>[{"name"=>"Robert Sandler, MD, MPH", "role"=>"STUDY_CHAIR", "affiliation"=>"UNC Lineberger Comprehensive Cancer Center"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Alliance for Clinical Trials in Oncology", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"National Cancer Institute (NCI)", "class"=>"NIH"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
