Working… Menu

Combination Chemotherapy Before and After Surgery in Treating Patients With Stomach Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002783
Recruitment Status : Completed
First Posted : August 24, 2004
Last Update Posted : July 3, 2013
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

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 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

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Primary Purpose: Treatment
Study Start Date : May 1996
Actual Primary Completion Date : January 2001
Actual Study Completion Date : January 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00002783

Layout table for location information
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Layout table for investigator information
Study Chair: David Paul Kelsen, MD Memorial Sloan Kettering Cancer Center
Layout table for additonal information Identifier: NCT00002783    
Other Study ID Numbers: 96-027
CDR0000064831 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: August 24, 2004    Key Record Dates
Last Update Posted: July 3, 2013
Last Verified: July 2013
Keywords provided by Memorial Sloan Kettering Cancer Center:
stage II gastric cancer
stage III gastric cancer
stage IV gastric cancer
adenocarcinoma of the stomach
Additional relevant MeSH terms:
Layout table for MeSH terms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Protective Agents
Vitamin B Complex
Growth Substances