Combination Chemotherapy Before and After Surgery in Treating Patients With Stomach Cancer
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| ClinicalTrials.gov Identifier: NCT00002783 |
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Recruitment Status :
Completed
First Posted : August 24, 2004
Last Update Posted : July 3, 2013
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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 them in different ways may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy before and after surgery in treating patients with high-risk stomach cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Gastric Cancer | Drug: cisplatin Drug: floxuridine Drug: fluorouracil Drug: leucovorin calcium Procedure: conventional surgery | Phase 2 |
OBJECTIVES: I. Evaluate the efficacy and toxicity of neoadjuvant cisplatin/fluorouracil (CDDP/5-FU) followed by surgery followed by adjuvant intraperitoneal floxuridine/leucovorin in patients with high-risk gastric cancer. II. Assess the quality of life and cost-benefit ratio associated with this treatment. III. Evaluate the sensitivity, specificity, and overall staging accuracy of laparoscopy with or without laparoscopic ultrasound in predicting the resectability rate (with and without neoadjuvant CDDP/5-FU), response to chemotherapy, and accuracy when compared to pathologic findings. IV. Correlate the presence of mutated vs. wild-type p53 suppressor oncogenes in endoscopic biopsies and resected tumor specimens with clinical outcome (defined as downstaging, failure pattern, and disease-free and overall survival) in patients treated with and without neoadjuvant CDDP/5-FU.
OUTLINE: The following acronyms are used: CDDP Cisplatin, NSC-119875 CF Leucovorin calcium, NSC-3590 5-FU Fluorouracil, NSC-19893 FUDR Floxuridine, NSC-27640 2-Drug Combination Chemotherapy followed by Surgery followed by Single-Agent Chemotherapy with Drug Modulation. CDDP/5-FU; followed by total or subtotal radical gastrectomy with D2 dissection; followed by FUDR; with CF.
PROJECTED ACCRUAL: A total of 50 patients will be entered over 2-2.5 years.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Primary Purpose: | Treatment |
| Official Title: | A PHASE II TRIAL OF NEOADJUVANT CISPLATIN-FLUOROURACIL CHEMOTHERAPY, SURGERY, AND INTRAPERITONEAL (IP) FLOXURIDINE (FUdR) PLUS LEUCOVORIN IN PATIENTS WITH GASTRIC CANCER |
| Study Start Date : | May 1996 |
| Actual Primary Completion Date : | January 2001 |
| Actual Study Completion Date : | January 2001 |
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Microscopically confirmed adenocarcinoma of the stomach or gastroesophageal junction Reviewed by Department of Pathology of participating institution Stage II-IV (T2, N1-2, M0 or T3-4, any N, M0) by physical exam, CT, and laparoscopy Potentially curable by surgery Suspected sites of metastasis proven M0 prior to entry
PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 60%-100% Hematopoietic: WBC at least 4,000 Platelets at least 150,000 Hepatic: Bilirubin less than 2 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 50 mL/min BUN no greater than 30 mg/dL Cardiovascular: No NYHA class III/IV status No active angina No myocardial infarction within 6 months No significant ventricular arrhythmia requiring medication No clinically significant conduction system abnormality Other: No serious intercurrent infection No nonmalignant medical illness that is uncontrolled or precludes study participation No psychiatric disorder that precludes informed consent No clinically significant auditory impairment No second malignancy within 5 years except: Basal cell skin cancer Carcinoma in situ of the cervix No pregnant or nursing women Negative pregnancy test required of fertile women Effective contraception required of fertile patients
PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002783
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | David Paul Kelsen, MD | Memorial Sloan Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00002783 |
| Other Study ID Numbers: |
96-027 CDR0000064831 ( Registry Identifier: PDQ (Physician Data Query) ) NCI-H96-0916 |
| First Posted: | August 24, 2004 Key Record Dates |
| Last Update Posted: | July 3, 2013 |
| Last Verified: | July 2013 |
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stage II gastric cancer stage III gastric cancer stage IV gastric cancer adenocarcinoma of the stomach |
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Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Leucovorin Cisplatin Fluorouracil Floxuridine Calcium Levoleucovorin Antineoplastic Agents |
Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Antidotes Protective Agents Vitamin B Complex Vitamins Micronutrients Nutrients Growth Substances |