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| Tracking Information | |||||||||
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| First Received Date ICMJE | November 1, 1999 | ||||||||
| Last Updated Date | July 23, 2008 | ||||||||
| Start Date ICMJE | January 1996 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00002722 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | High-Dose Chemotherapy in Treating Patients With Advanced Stomach Cancer | ||||||||
| Official Title ICMJE | RANDOMIZED PHASE II STUDY OF A WEEKLY 24H-INFUSION OF HIGH-DOSE 5-FU PLUS OR MINUS FOLINIC ACID (HD-FU/FA) VERSUS HD-FU/FA PLUS BIWEEKLY CISPLATIN VERSUS FAMTX (5-FU/ADRIAMYCIN/METHOTREXATE) IN ADVANCED GASTRIC CANCER, AN EORTC/AIO INTERGROUP TRIAL | ||||||||
| Brief Summary | 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 higher doses may kill more tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of high-dose chemotherapy in treating patients with advanced stomach cancer. |
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| Detailed Description | OBJECTIVES: I. Determine the response rates in patients with advanced gastric cancer treated with high-dose fluorouracil (5-FU) with vs without high-dose leucovorin (CF) vs high-dose 5-FU/CF/cisplatin. II. Determine the toxic effects of these regimens in these patients. III. Assess the symptomatic improvement in these patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, WHO performance status (0 or 1 vs 2), and disease stage (metastatic vs locally advanced). Patients are randomized to 1 of 3 treatment arms. Arm I: Patients receive fluorouracil (5-FU) IV over 24 hours weekly for 6 weeks. Arm II: Patients receive leucovorin calcium (CF) IV over 2 hours followed by 5-FU IV over 24 hours weekly for 6 weeks. Arm III: Patients receive CF and 5-FU as in arm II and cisplatin IV over 1 hour on days 1, 15, and 29. Treatment repeats every 7 weeks for a maximum of 4 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 8 weeks. PROJECTED ACCRUAL: A total of 65-135 patients (21-45 per arm) will be accrued for this study. |
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| Study Phase | Phase II | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized | ||||||||
| Condition ICMJE | Gastric Cancer | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Estimated Enrollment ICMJE | 135 | ||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS: Histologically confirmed gastric cancer that is either metastatic or locally advanced and inoperable Bidimensionally measurable disease No CNS metastasis PATIENT CHARACTERISTICS: Age: 75 and under Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: Granulocyte count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.7 mg/dL Renal: Creatinine no greater than 1.3 mg/dL Creatinine clearance greater than 60 mL/min Cardiovascular: No myocardial infarction within past 12 months No coronary heart disease requiring drug therapy Congestive heart failure or arrhythmia treatable with standard medication allowed Other: No active infection No history of severe mental disorder No other malignancy within past 10 years except carcinoma in situ of the cervix or nonmelanoma skin cancer Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Not specified |
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| Gender | Both | ||||||||
| Ages | up to 75 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Germany | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00002722 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | CDR0000064578, EORTC-40953, GER-AIO-02/95 | ||||||||
| Study Sponsor ICMJE | European Organization for Research and Treatment of Cancer | ||||||||
| Collaborators ICMJE | Arbeitsgemeinschaft fur Internistische Onkologie | ||||||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||
| Verification Date | May 2007 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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