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Trial NCT00026130

Resource URI: http://static.linkedct.org/resource/trials/NCT00026130
PropertyValue
linkedct:brief_title Combination Chemotherapy and Radiation Therapy in Treating Patients With Pancreatic Cancer
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/5381>
linkedct:condition <http://static.linkedct.org/resource/condition/9587>
linkedct:criteria DISEASE CHARACTERISTICS: - Histologically confirmed pancreatic adenocarcinoma - Non-metastatic disease that is unresectable due to any of the following: - Tumor greater than 5 cm - Bulky lymph nodes greater than 2 cm, but within the radiation port - Vascular involvement or impingement of major vessels - Involvement of colon, adrenal glands, or kidney - Measurable or evaluable disease - No prior therapy for pancreatic adenocarcinoma - No peritoneal seeding or other evidence of metastatic disease by laparotomy or laparoscopy PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - CTC 0-2 Life expectancy: - Not specified Hematopoietic: - WBC at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 2.0 mg/dL - AST no greater than 3 times upper limit of normal Renal: - Creatinine no greater than 2.0 mg/dL Cardiovascular: - No myocardial infarction within the past 6 months Other: - No other uncontrolled serious medical or psychiatric illness that would preclude study compliance - No other malignancy within the past 5 years except limited or curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics Chemotherapy: - See Disease Characteristics Endocrine therapy: - See Disease Characteristics Radiotherapy: - No prior abdominal radiotherapy Surgery: - At least 2 weeks since prior major surgery
linkedct:description OBJECTIVES: - Determine the overall survival of patients with locally advanced non-metastatic pancreatic adenocarcinoma treated with gemcitabine, fluorouracil, and radiotherapy. - Determine the time to progression in patients treated with this regimen. - Determine the overall clinical response in patients treated with this regimen. - Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes once weekly and fluorouracil IV continuously on days 1-5 weekly for 6 weeks. Patients concurrently undergo radiotherapy 5 days a week for 6 weeks. Three weeks after the completion of chemoradiotherapy, patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-3. Treatment repeats every 4 weeks for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year and then every 3 months for 2 years. PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study within 24 months.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 18 Years
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date November 9, 2001
linkedct:id NCT00026130
rdfs:label Trial NCT00026130
linkedct:lastchanged_date February 6, 2009
linkedct:lead_sponsor_agency Cancer and Leukemia Group B
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linkedct:nct_id NCT00026130
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linkedct:official_title A Phase II Trial of Gemcitabine, 5-Fluorouracil and Radiation Therapy in Locally Advanced Non-Metastatic Pancreatic Adenocarcinoma
linkedct:org_study_id CDR0000068988
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/21932>
linkedct:overall_status Active, not recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00026130>
linkedct:phase Phase 2
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/1112>
linkedct:secondary_id CALGB-80003
linkedct:source National Cancer Institute (NCI)
linkedct:start_date September 2001
linkedct:study_design Treatment
linkedct:study_type Interventional
linkedct:summary RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have locally advanced pancreatic cancer.
rdf:type linkedct:trials
linkedct:verification_date July 2004