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Surgery With or Without Combination Chemotherapy in Treating Patients With Stomach Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Surgery With or Without Combination Chemotherapy in Treating Patients With Stomach Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Surgery With or Without Combination Chemotherapy in Treating Patients With Stomach Cancer Clinical research trials and Surgery With or Without Combination Chemotherapy in Treating Patients With Stomach Cancer health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Surgery With or Without Combination Chemotherapy in Treating Patients With Stomach Cancer. Surgery With or Without Combination Chemotherapy in Treating Patients With Stomach Cancer Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Surgery With or Without Combination Chemotherapy in Treating Patients With Stomach Cancer clinical trial. Participants oftentimes recieve the most expert healthcare available for their Surgery With or Without Combination Chemotherapy in Treating Patients With Stomach Cancer condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Surgery With or Without Combination Chemotherapy in Treating Patients With Stomach Cancer  Surgery With or Without Combination Chemotherapy in Treating Patients With Stomach Cancer
Surgery With or Without Combination Chemotherapy in Treating Patients With Stomach Cancer
For Condition: mixed adenocarcinoma of the stomach,diffuse adenocarcinoma of the stomach,stage 2 gastric cancer,stage 3 gastric cancer,stage 4 gastric cancer,intestinal adenocarcinoma of the stomach
Status: No longer recruiting
Sponsor(s): EORTC Gastrointestinal Tract Cancer Cooperative Group ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if surgery alone or surgery combined with chemotherapy is more effective in treating stomach cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have stage II, stage III, or stage IV stomach cancer.
Details: OBJECTIVES: - Compare overall survival in patients with locally advanced gastric cancer treated with surgery alone or in combination with neoadjuvant cisplatin, leucovorin calcium and fluorouracil. - Compare these two regimens in terms of the rate of complete resection, time to progression, and morbidity in these patients. - Evaluate toxicity of and disease response to neoadjuvant chemotherapy in these patients. - Evaluate quality of life and performance status in these patients pre- and post-surgery and compare quality of life for both regimens. OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to center, primary tumor category (cT3 or cT4), localization of tumor (upper third including cardia II or III vs middle and lower third), gender, and histological subtype (intestinal vs nonintestinal). Patients are randomized to one of two treatment arms. - Patients receive cisplatin IV over 1 hour on days 1, 15, and 29. Patients also receive leucovorin calcium IV over 2 hours followed by fluorouracil IV over 24 hours on days 1, 8, 15, 22, 29, and 36. A second course is administered beginning 2 weeks later in the absence of disease progression or unacceptable toxicity. Patients undergo resection and lymphadenectomy on days 57-63 of the second course of chemotherapy. - Arm II: Patients undergo resection and lymphadenectomy within 14 days of randomization. Quality of life is assessed before randomization, every 3 months for 1 year and at 2 years after randomization. Patients are followed every 3 months for 1 year, every 6 months for 2 years, then every 3 months thereafter until death. PROJECTED ACCRUAL: A total of 360 patients (180 per arm) will be accrued for this study over 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/69 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven stage II-IV adenocarcinoma of the stomach including cardia carcinoma types II and III - Locally resectable disease - No distant metastases except M1 lymph nodes - No evidence of peritoneal carcinomatosis - Free tumor cells in lavage at laparoscopy allowed - No uncontrolled bleeding of the primary tumor - No gastric outlet syndrome or complete tumor stenosis that would require total parenteral nutrition PATIENT CHARACTERISTICS: Age: - 18 to 69 Performance status: - WHO 0-1 Life expectancy: - Not specified Hematopoietic: - WBC greater than 4,000/mm^3 - Absolute neutrophil count greater than 2,000/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.25 times upper limit of normal (ULN) - Prothrombin rate at least 70% Renal: - Creatinine no greater than 1.25 times ULN - Creatinine clearance greater than 60 mL/min Cardiovascular: - No prior atrial or ventricular arrhythmias - No prior congestive heart failure - No myocardial infarction within the past 6 months Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other prior or concurrent neoplasm except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix - No active infection - No allergy to protocol drugs - No dementia or significantly altered mental status - No other serious medical condition that would prevent compliance PRIOR CONCURRENT THERAPY: Biologic therapy: - No filgrastim (G-CSF) within 48 hours prior to chemotherapy Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy Surgery: - See Disease Characteristics - No prior stent implantation - No prior laser therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ChristophSchuhmacher, , Klinikum Rechts Der Isar/Technische Universitaet Muenchen
Department of Medicine III
Erlangen, , D-91054
Germany
Institut Jules Bordet
Brussels, , 1000
Belgium
Klinik & Poliklinik fur Strahlentherapie der Universitat zu Koln
Koln, , D-50924
Germany
Universitaetsklinik Duesseldorf
Duesseldorf, , D-40225
Germany
Kreiskrankenhaus Meissen
Meissen, , D-01657
Germany
Kliniken Essen - Mitte
ESSEN, , D-45136
Germany
Klinikum der J.W. Goethe Universitaet
Frankfurt, , D-60590
Germany
Robert Roessle Klinik
Berlin, , D-13122
Germany
Academisch Ziekenhuis Maastricht
Maastricht, , 6202 AZ
Netherlands
Westfaelische Wilhelms-Universitaet
Muenster, , DOH-48149
Germany
National Cancer Institute of Egypt
Cairo, ,
Egypt
Staedtisches Krankenhaus
Solingen, , D-42653
Germany
Klinikum Rechts Der Isar/Technische Universitaet Muenchen
Munich, , D-81675
Germany
Evangelisches Bethesda Krankenhaus GmbH
ESSEN, , D-45355
Germany
Krankenhaus Nordwest
Frankfurt, , D-60488
Germany
Instituto Portugues de Oncologia Centro do Porto, SA
Porto, , 4200
Portugal
Medizinische Klinik I
Dresden, , D-01307
Germany
Universitatsklinik - Saarland
Homburg, , D-66421
Germany
Additional Information:
Study ID Numbers: CDR0000067315; EORTC-40954
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004099
Other Mixed Adenocarcinoma Of The Stomach Studies:
1. Biological Therapy in Treating Patients With Advanced Cancer
2. Combination Chemotherapy Followed by Surgery in Treating Patients With Stomach Cancer
3. Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Gastric Cancer
4. Surgery With or Without Combination Chemotherapy in Treating Patients With Stomach Cancer
5. Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus
Related Studies:
Other mixed adenocarcinoma of the stomach Clinical Trials
Other Clinical Trials
Other Erlangen Clinical Trials
Surgery With or Without Combination Chemotherapy in Treating Patients With Stomach Cancer
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