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A Phase II Trial of Preoperative Chemotherapy and Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Stomach (NCT00003862)

National Cancer Institute (NCI)
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 with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy and radiation therapy in treating patients who have stomach cancer.
  • Drug: cisplatin
    • Drug: fluorouracil
      • Drug: leucovorin calcium
        • Drug: paclitaxel
          • Procedure: conventional surgery
            • Procedure: neoadjuvant therapy
              • Radiation: radiation therapy
                Ages eligible for Study
                all
                Genders eligible for Study
                All
                Accepts Healthy Volunteers
                No
                OBJECTIVES:

                - Determine the feasibility of preoperative chemoradiotherapy in patients with potentially resectable adenocarcinoma of the stomach.

                - Determine the pathologic response rate, curative resection rate, and survival in patients treated with this regimen.

                - Determine the tolerability of this regimen in these patients.

                OUTLINE: Patients receive fluorouracil IV over 24 hours on days 1-21, cisplatin IV over 1 hour on days 1-5, and leucovorin calcium IV over 15 minutes on days 1, 8, 15, and 22. A second course is administered beginning on day 29.

                Chemoradiotherapy begins at the end of the second course of chemotherapy and 1 week of rest (day 57). Patients receive fluorouracil IV over 24 hours 5 days a week concurrently with radiotherapy for 5 weeks and paclitaxel IV over 3 hours once weekly during these 5 weeks on days 1, 8, 15, 22, and 29.

                Approximately 4-5 weeks after chemoradiotherapy, patients with no evidence of metastatic disease undergo surgical resection.

                Patients are followed every 3 months for 1 year, every 6 months for 5 years, then annually thereafter.

                PROJECTED ACCRUAL: A total of 21-49 patients will be accrued for this study within 2.5 years.

                55 locations

                United States (55)
                • Providence Alaska Medical Center
                  Anchorage, Alaska, United States, 99519-6604
                • Foundation for Cancer Research and Education
                  Phoenix, Arizona, United States, 85013
                • Mount Diablo Medical Center
                  Concord, California, United States, 94524-4110
                • Northridge Hospital Medical Center
                  Northridge, California, United States, 91328
                • University of California Davis Cancer Center
                  Sacramento, California, United States, 95817
                • Penrose - St. Francis Health Services
                  Colorado Springs, Colorado, United States, 80933
                • St. Joseph Hospital
                  Denver, Colorado, United States, 80218-1191
                • Presbyterian-St Luke's Medical Center
                  Denver, Colorado, United States, 80218
                • Rose Medical Center
                  Denver, Colorado, United States, 80220
                • CCOP - Colorado Cancer Research Program, Incorporated
                  Denver, Colorado, United States, 80224
                • Swedish Medical Center
                  Englewood, Colorado, United States, 80110
                • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
                  Grand Junction, Colorado, United States, 81502-1628
                • CCOP - Atlanta Regional
                  Atlanta, Georgia, United States, 30342-1701
                • Lutheran General Hospital Cancer Care Center
                  Park Ridge, Illinois, United States, 60068
                • Indiana University Cancer Center
                  Indianapolis, Indiana, United States, 46202-5289
                • Veterans Affairs Medical Center - Indianapolis (Roudebush)
                  Indianapolis, Indiana, United States, 46202
                • Ball Memorial Hospital Cancer Center
                  Muncie, Indiana, United States, 47303-3499
                • Porter Memorial Hospital
                  Valparaiso, Indiana, United States, 46383
                • Wendt Regional Cancer Center of Finley Hospital
                  Dubuque, Iowa, United States, 52001
                • McLaren Regional Cancer Center
                  Flint, Michigan, United States, 48532-3685
                • Ellis Fischel Cancer Center at University of Missouri - Columbia
                  Columbia, Missouri, United States, 65203
                • CCOP - Kansas City
                  Kansas City, Missouri, United States, 64131
                • Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
                  Omaha, Nebraska, United States, 68114-4199
                • Norris Cotton Cancer Center at Dartmouth Medical School
                  Lebanon, New Hampshire, United States, 03756-0002
                • Monmouth Medical Center
                  Long Branch, New Jersey, United States, 07740-6395
                • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
                  Mount Holly, New Jersey, United States, 08060
                • Fox Chase Cancer Center at St. Francis Medical Center
                  Trenton, New Jersey, United States, 08629
                • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
                  Syracuse, New York, United States, 13217
                • Presbyterian Hospital
                  Charlotte, North Carolina, United States, 28233-3549
                • Wayne Memorial Hospital, Inc.
                  Goldsboro, North Carolina, United States, 27533
                • Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina
                  Greenville, North Carolina, United States, 27835-6028
                • Ireland Cancer Center
                  Cleveland, Ohio, United States, 44106-5065
                • CCOP - Dayton
                  Dayton, Ohio, United States, 45429
                • CCOP - Toledo Community Hospital
                  Toledo, Ohio, United States, 43623-3456
                • St. Luke's Hospital Cancer Center
                  Bethlehem, Pennsylvania, United States, 18015
                • Bryn Mawr Hospital
                  Bryn Mawr, Pennsylvania, United States, 19010
                • Mercy Fitzgerald Hospital
                  Darby, Pennsylvania, United States, 19023
                • Delaware County Memorial Hospital
                  Drexel Hill, Pennsylvania, United States, 19026
                • Paoli Memorial Hospital
                  Paoli, Pennsylvania, United States, 19301-1792
                • Albert Einstein Cancer Center
                  Philadelphia, Pennsylvania, United States, 19141-3098
                • Western Pennsylvania Hospital
                  Pittsburgh, Pennsylvania, United States, 15224
                • CCOP - MainLine Health
                  Wynnewood, Pennsylvania, United States, 19096
                • Lankenau Cancer Center at Lankenau Hospital
                  Wynnewood, Pennsylvania, United States, 19096
                • Greenville Hospital System
                  Greenville, South Carolina, United States, 29605
                • CCOP - Greenville
                  Greenville, South Carolina, United States, 29615
                • CCOP - Upstate Carolina
                  Spartanburg, South Carolina, United States, 29303
                • Rapid City Regional Hospital
                  Rapid City, South Dakota, United States, 57709
                • Harrington Cancer Center
                  Amarillo, Texas, United States, 79106
                • University of Texas - MD Anderson Cancer Center
                  Houston, Texas, United States, 77030-4009
                • McKay-Dee Hospital Center
                  Ogden, Utah, United States, 84403
                • Utah Valley Regional Medical Center - Provo
                  Provo, Utah, United States, 84604
                • LDS Hospital
                  Salt Lake City, Utah, United States, 84143
                • University of Washington Medical Center
                  Seattle, Washington, United States, 98195-6043
                • CCOP - Marshfield Clinic Research Foundation
                  Marshfield, Wisconsin, United States, 54449
                • Columbia Hospital
                  Milwaukee, Wisconsin, United States, 53211
                Status:
                completed
                Type:
                Interventional
                Phase:
                Start:
                31 October, 1999
                Updated:
                16 July, 2013
                Participants:
                0
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