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| Sponsor: | Radiation Therapy Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003862 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastric Cancer |
Drug: cisplatin Drug: fluorouracil Drug: leucovorin calcium Drug: paclitaxel Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Trial of Preoperative Chemotherapy and Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Stomach |
| Study Start Date: | November 1999 |
OBJECTIVES:
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven adenocarcinoma of the stomach
Stage IB, II, IIIA, IIIB, and IV (T2-3, any N, M0)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Neurologic:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations
Hide Study Locations| United States, Alaska | |
| Providence Alaska Medical Center | |
| Anchorage, Alaska, United States, 99519-6604 | |
| United States, Arizona | |
| Foundation for Cancer Research and Education | |
| Phoenix, Arizona, United States, 85013 | |
| United States, California | |
| 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 | |
| United States, Colorado | |
| CCOP - Colorado Cancer Research Program, Incorporated | |
| Denver, Colorado, United States, 80224 | |
| Penrose - St. Francis Health Services | |
| Colorado Springs, Colorado, United States, 80933 | |
| Presbyterian-St Luke's Medical Center | |
| Denver, Colorado, United States, 80218 | |
| Rose Medical Center | |
| Denver, Colorado, United States, 80220 | |
| St. Joseph Hospital | |
| Denver, Colorado, United States, 80218-1191 | |
| St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | |
| Grand Junction, Colorado, United States, 81502-1628 | |
| Swedish Medical Center | |
| Englewood, Colorado, United States, 80110 | |
| United States, Georgia | |
| CCOP - Atlanta Regional | |
| Atlanta, Georgia, United States, 30342-1701 | |
| United States, Illinois | |
| Lutheran General Hospital Cancer Care Center | |
| Park Ridge, Illinois, United States, 60068 | |
| United States, Indiana | |
| Ball Memorial Hospital Cancer Center | |
| Muncie, Indiana, United States, 47303-3499 | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5289 | |
| Porter Memorial Hospital | |
| Valparaiso, Indiana, United States, 46383 | |
| Veterans Affairs Medical Center - Indianapolis (Roudebush) | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| Wendt Regional Cancer Center of Finley Hospital | |
| Dubuque, Iowa, United States, 52001 | |
| United States, Michigan | |
| McLaren Regional Cancer Center | |
| Flint, Michigan, United States, 48532-3685 | |
| United States, Missouri | |
| CCOP - Kansas City | |
| Kansas City, Missouri, United States, 64131 | |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | |
| Columbia, Missouri, United States, 65203 | |
| United States, Nebraska | |
| Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha | |
| Omaha, Nebraska, United States, 68114-4199 | |
| United States, New Hampshire | |
| Norris Cotton Cancer Center at Dartmouth Medical School | |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| United States, New Jersey | |
| 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 | |
| United States, New York | |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | |
| Syracuse, New York, United States, 13217 | |
| United States, North Carolina | |
| Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina | |
| Greenville, North Carolina, United States, 27835-6028 | |
| Presbyterian Hospital | |
| Charlotte, North Carolina, United States, 28233-3549 | |
| Wayne Memorial Hospital, Inc. | |
| Goldsboro, North Carolina, United States, 27533 | |
| United States, Ohio | |
| Ireland Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| CCOP - Toledo Community Hospital | |
| Toledo, Ohio, United States, 43623-3456 | |
| CCOP - Dayton | |
| Dayton, Ohio, United States, 45429 | |
| United States, Pennsylvania | |
| Paoli Memorial Hospital | |
| Paoli, Pennsylvania, United States, 19301-1792 | |
| Bryn Mawr Hospital | |
| Bryn Mawr, Pennsylvania, United States, 19010 | |
| CCOP - MainLine Health | |
| Wynnewood, Pennsylvania, United States, 19096 | |
| Delaware County Memorial Hospital | |
| Drexel Hill, Pennsylvania, United States, 19026 | |
| Lankenau Cancer Center at Lankenau Hospital | |
| Wynnewood, Pennsylvania, United States, 19096 | |
| Mercy Fitzgerald Hospital | |
| Darby, Pennsylvania, United States, 19023 | |
| Albert Einstein Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19141-3098 | |
| St. Luke's Hospital Cancer Center | |
| Bethlehem, Pennsylvania, United States, 18015 | |
| Western Pennsylvania Hospital | |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| United States, South Carolina | |
| CCOP - Greenville | |
| Greenville, South Carolina, United States, 29615 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| Greenville Hospital System | |
| Greenville, South Carolina, United States, 29605 | |
| United States, South Dakota | |
| Rapid City Regional Hospital | |
| Rapid City, South Dakota, United States, 57709 | |
| United States, Texas | |
| Harrington Cancer Center | |
| Amarillo, Texas, United States, 79106 | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
| United States, Utah | |
| LDS Hospital | |
| Salt Lake City, Utah, United States, 84143 | |
| McKay-Dee Hospital Center | |
| Ogden, Utah, United States, 84403 | |
| Utah Valley Regional Medical Center - Provo | |
| Provo, Utah, United States, 84604 | |
| United States, Washington | |
| University of Washington Medical Center | |
| Seattle, Washington, United States, 98195-6043 | |
| United States, Wisconsin | |
| CCOP - Marshfield Clinic Research Foundation | |
| Marshfield, Wisconsin, United States, 54449 | |
| Columbia Hospital | |
| Milwaukee, Wisconsin, United States, 53211 | |
| Study Chair: | Jaffer A. Ajani, MD | M.D. Anderson Cancer Center |
More Information
| Study ID Numbers: | CDR0000067026, RTOG-9904, RTOG-DEV-1046 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003862 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I gastric cancer stage II gastric cancer stage III gastric cancer stage IV gastric cancer adenocarcinoma of the stomach |
|
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Gastrointestinal Diseases Physiological Effects of Drugs Leucovorin Stomach Diseases Neoplasms by Site Cisplatin Stomach Neoplasms Therapeutic Uses Vitamins Micronutrients |
Digestive System Neoplasms Vitamin B Complex Growth Substances Mitosis Modulators Antimitotic Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Digestive System Diseases Radiation-Sensitizing Agents Paclitaxel Fluorouracil Tubulin Modulators Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic |