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Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Gastric Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Gastric Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Gastric Cancer Clinical research trials and Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Gastric Cancer healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Gastric Cancer. Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Gastric Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Gastric Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Gastric Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Gastric Cancer  Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Gastric Cancer
Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Gastric Cancer
For Condition: stage 2 gastric cancer,adenocarcinoma of the stomach,stage 3 gastric cancer,stage 4 gastric cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Eastern Cooperative Oncology Group
Synopsis: 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, radiation therapy, and surgery may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy, surgery, and radiation therapy in treating patients with gastric cancer.
Details: OBJECTIVES: I. Evaluate the tolerability and toxic effects of neoadjuvant cisplatin plus paclitaxel and postoperative chemoradiation therapy with fluorouracil plus leucovorin calcium in patients with high-risk gastric cancer. II. Assess the pathologic response of gastric tumors to neoadjuvant cisplatin plus paclitaxel chemotherapy, and preliminarily assess the patterns of failure and disease free and overall survival. PROTOCOL OUTLINE: Patients receive 3 courses of preoperative neoadjuvant chemotherapy given on day 1 every 21 days. Courses consist of an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel on day 1. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment. Patients are followed every month for the first 3 months, every 3 months for the next 21 months, every 6 months for the next year, and annually thereafter. PROJECTED ACCRUAL: Approximately 30-42 patients will be accrued over 18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction - Localized cancer that is potentially curable by surgery (T2, N1-2, M0 or T3-4, any N, M0) - No metastatic cancer to the ovaries --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: No prior radiation therapy, except for skin cancer - Surgery: See Disease Characteristics --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Hematopoietic: WBC at least 4,000 cells/mm3; Platelet count at least 150,000/mm3 - Hepatic: Bilirubin less than 2 mg/dL - Renal: Creatinine no greater than 1.5 mg/dL; Creatinine clearance greater than 50 mL/min - Other: No clinically significant auditory impairment; Caloric intake must be at least 1500 kcal/day; No prior history of cancer within the past 5 years except for basal cell carcinoma of the skin or in situ carcinoma of the cervix; Not pregnant or lactating; Fertile patients must use adequate contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidRosenthal, Study Chair, Eastern Cooperative Oncology Group
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
University of Rochester Cancer Center
Rochester, New York, 14642
United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, 46202
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
United States
Morristown Memorial Hospital
Morristown, New Jersey, 07962-1956
United States
Raritan Bay Medical Center
Perth Amboy, New Jersey, 08861
United States
Somerset Medical Center
Somerville, New Jersey, 08876
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
CCOP - Colorado Cancer Research Program, Inc.
Denver, Colorado, 80209-5031
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Albert Einstein Comprehensive Cancer Center
Bronx, New York, 10461
United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, 60611
United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
United States
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville, Tennessee, 37212
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
CCOP - Ochsner
New Orleans, Louisiana, 70121
United States
CCOP - Evanston
Evanston, Illinois, 60201
United States
New England Medical Center Hospital
Boston, Massachusetts, 02111
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, 54449
United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
United States
Additional Information:
Study ID Numbers: CDR0000066237; E-7296
Study Start Date: February 1999
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003298
Other Adenocarcinoma Of The Stomach Studies:
1. Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus
2. Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus or Stomach
3. Bortezomib With or Without Irinotecan in Treating Patients With Cancer of the Gastroesophageal Junction or Stomach
4. Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Gastric Cancer
5. Erlotinib in Treating Patients With Locally Advanced or Metastatic Stomach Cancer or Gastroesophageal Junction Cancer
Related Studies:
Other adenocarcinoma of the stomach Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Gastric Cancer
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