Nctid:
NCT00001431
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-16"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000010190", "term"=>"Pancreatic Neoplasms"}, {"id"=>"D000005770", "term"=>"Gastrointestinal Neoplasms"}, {"id"=>"D000004067", "term"=>"Digestive System Neoplasms"}], "ancestors"=>[{"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000004701", "term"=>"Endocrine Gland Neoplasms"}, {"id"=>"D000004066", "term"=>"Digestive System Diseases"}, {"id"=>"D000010182", "term"=>"Pancreatic Diseases"}, {"id"=>"D000004700", "term"=>"Endocrine System Diseases"}, {"id"=>"D000005767", "term"=>"Gastrointestinal Diseases"}], "browseLeaves"=>[{"id"=>"M13110", "name"=>"Pancreatic Neoplasms", "asFound"=>"Pancreatic Neoplasms", "relevance"=>"HIGH"}, {"id"=>"M8886", "name"=>"Gastrointestinal Neoplasms", "asFound"=>"Gastrointestinal Neoplasms", "relevance"=>"HIGH"}, {"id"=>"M7256", "name"=>"Digestive System Neoplasms", "asFound"=>"Gastrointestinal Neoplasms", "relevance"=>"HIGH"}, {"id"=>"M7863", "name"=>"Endocrine Gland Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M13102", "name"=>"Pancreatic Diseases", "relevance"=>"LOW"}, {"id"=>"M7862", "name"=>"Endocrine System Diseases", "relevance"=>"LOW"}, {"id"=>"T4387", "name"=>"Pancreatic Cancer", "asFound"=>"Cancer of the Pancreas", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"Gland and Hormone Related Diseases", "abbrev"=>"BC19"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000093542", "term"=>"Gemcitabine"}], "ancestors"=>[{"id"=>"D000000964", "term"=>"Antimetabolites, Antineoplastic"}, {"id"=>"D000000963", "term"=>"Antimetabolites"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000000970", "term"=>"Antineoplastic Agents"}], "browseLeaves"=>[{"id"=>"M2985", "name"=>"Gemcitabine", "asFound"=>"Before", "relevance"=>"HIGH"}, {"id"=>"M22554", "name"=>"Pancrelipase", "relevance"=>"LOW"}, {"id"=>"M13114", "name"=>"Pancreatin", "relevance"=>"LOW"}, {"id"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Gastrointestinal Agents", "abbrev"=>"Gast"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>20}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1995-02"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2000-11", "completionDateStruct"=>{"date"=>"2000-11"}, "lastUpdateSubmitDate"=>"2008-03-03", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"2002-12-09", "lastUpdatePostDateStruct"=>{"date"=>"2008-03-04", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2002-12-10", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Combined Modality", "GI Cancer", "Pancreatic Cancer", "Radiotherapy"], "conditions"=>["Gastrointestinal Neoplasms", "Pancreatic Neoplasms"]}, "referencesModule"=>{"references"=>[{"pmid"=>"6313514", "type"=>"BACKGROUND", "citation"=>"Morohoshi T, Held G, Kloppel G. Exocrine pancreatic tumours and their histological classification. A study based on 167 autopsy and 97 surgical cases. Histopathology. 1983 Sep;7(5):645-61. doi: 10.1111/j.1365-2559.1983.tb02277.x."}, {"pmid"=>"2579295", "type"=>"BACKGROUND", "citation"=>"Rosenberg JM, Welch JP, Macaulay WP. Cancer of the head of the pancreas: an institutional review with emphasis on surgical therapy. J Surg Oncol. 1985 Mar;28(3):217-21. doi: 10.1002/jso.2930280315."}]}, "descriptionModule"=>{"briefSummary"=>"Radiotherapy plus Single-Agent Chemotherapy/Radiosensitization. Involved-field irradiation using 4-15 MV photons; plus Gemcitabine, NSC-613327.", "detailedDescription"=>"This is a Phase I trial of gemcitabine given weekly as a 30 minute infusion administered concurrently with radiation in patients with locally advanced or locally recurrent pancreatic carcinoma. Patients will be treated with external beam radiation therapy in a standard manner. Gemcitabine will be administered as a 30 minute infusion beginning on the first day of irradiation and weekly afterwards for a total of 5 doses. Patients will be assessed clinically for acute toxicity which will be graded per RTOG and DCT toxicity grading system."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS:\n\nHistologically or cytologically proven unresectable adenocarcinoma of the pancreas or ampulla of Vater. Surgical consult at NCI confirming unresectability fulfills requirement.\n\nUnresectable disease defined as tumor with: Gross involvement of regional nodes or direct extension to any of the following sites: Duodenum, Spleen, Bile duct , Colon, Peripancreatic tissue, Adjacent large vessels, Stomach.\n\nMetastatic disease requiring local radiotherapy allowed. No CNS metastasis.\n\nNo lymphomas or neuroendocrine tumors.\n\nNo peritoneal carcinomatosis.\n\nPRIOR/CONCURRENT THERAPY:\n\nBiologic Therapy: More than 4 weeks since immunotherapy.\n\nChemotherapy:\n\nNo prior chemotherapy for newly diagnosed disease.\n\nMore than 4 weeks since chemotherapy for recurrent disease (6 weeks since nitrosoureas, mitomycin, or suramin).\n\nEndocrine Therapy: More than 4 weeks since hormonal therapy.\n\nRadiotherapy:\n\nNo prior radiotherapy for newly diagnosed disease.\n\nNo prior abdominal or pelvic radiotherapy.\n\nMore than 4 weeks since radiotherapy for recurrent disease. No prior radiotherapy for locally advanced disease after resection allowed.\n\nSurgery:\n\nPrior resection allowed.\n\nBiliary decompression or gastric bypass allowed.\n\nPATIENT CHARACTERISTICS:\n\nAge: 18 and over.\n\nPerformance status: ECOG 0-2.\n\nHematopoietic:\n\nANC greater than 2,000/mm(3).\n\nPlatelets greater than 100,000/mm(3).\n\nHepatic: AST/ALT no greater than 2.5 times normal.\n\nRenal:\n\nCreatinine less than 1.5 mg/dL.\n\nCreatinine clearance at least 60 mL/min,\n\nCardiovascular:\n\nNo myocardial infarction within 6 months.\n\nNo unstable angina.\n\nNo congestive heart failure (NYHA class III/IV).\n\nOTHER:\n\nHIV seronegative.\n\nNo medical or psychiatric contraindication to protocol therapy.\n\nNo concurrent malignancy other than: Skin cancer, Cervical carcinoma in situ.\n\nNo pregnant or nursing women.\n\nAdequate contraception required of fertile patients."}, "identificationModule"=>{"nctId"=>"NCT00001431", "briefTitle"=>"A Phase I Trial of Gemcitabine and Radiation in Locally Advanced Unresectable Cancer of the Pancreas", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"A Phase I Trial of Gemcitabine and Radiation in Locally Advanced Unresectable Cancer of the Pancreas", "orgStudyIdInfo"=>{"id"=>"950075"}, "secondaryIdInfos"=>[{"id"=>"95-C-0075"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"gemcitabine", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"National Cancer Institute (NCI)", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Cancer Institute (NCI)", "class"=>"NIH"}}}}
