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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000067026 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | |||
| fluorouracil | Drug | |||
| leucovorin calcium | Drug | |||
| paclitaxel | Drug | |||
| conventional surgery | Procedure | |||
| neoadjuvant therapy | Procedure | |||
| radiation therapy | Radiation |
DISEASE CHARACTERISTICS:
Histologically proven adenocarcinoma of the stomach
Stage IB, II, IIIA, IIIB, and IV (T2-3, any N, M0)
Potentially resectable
May involve the gastroesophageal junction, but bulk of tumor must be in the stomach
No distant metastases
No pleural or pericardial effusion
No peritoneal disease diagnosed by laparoscopy
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Neurologic:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Jaffer A. Ajani, MD | M.D. Anderson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Alaska Medical Center | Anchorage | Alaska | 99519-6604 | United States | ||
| Foundation for Cancer Research and Education |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16921048 | Result | Ajani JA, Winter K, Okawara GS, Donohue JH, Pisters PW, Crane CH, Greskovich JF, Anne PR, Bradley JD, Willett C, Rich TA. Phase II trial of preoperative chemoradiation in patients with localized gastric adenocarcinoma (RTOG 9904): quality of combined modality therapy and pathologic response. J Clin Oncol. 2006 Aug 20;24(24):3953-8. doi: 10.1200/JCO.2006.06.4840. | |
| Result | Okawara GS, Winter K, Donohue JH, et al.: A phase II trial of preoperative chemotherapy and chemoradiotherapy for potentially resectable adenocarcinoma of the stomach (RTOG 99-04). [Abstract] J Clin Oncol 23 (Suppl 16): A-4019, 312s, 2005. |
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| Phoenix |
| Arizona |
| 85013 |
| United States |
| Mount Diablo Medical Center | Concord | California | 94524-4110 | United States |
| Northridge Hospital Medical Center | Northridge | California | 91328 | United States |
| University of California Davis Cancer Center | Sacramento | California | 95817 | United States |
| Penrose - St. Francis Health Services | Colorado Springs | Colorado | 80933 | United States |
| St. Joseph Hospital | Denver | Colorado | 80218-1191 | United States |
| Presbyterian-St Luke's Medical Center | Denver | Colorado | 80218 | United States |
| Rose Medical Center | Denver | Colorado | 80220 | United States |
| CCOP - Colorado Cancer Research Program, Incorporated | Denver | Colorado | 80224 | United States |
| Swedish Medical Center | Englewood | Colorado | 80110 | United States |
| St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction | Colorado | 81502-1628 | United States |
| CCOP - Atlanta Regional | Atlanta | Georgia | 30342-1701 | United States |
| Lutheran General Hospital Cancer Care Center | Park Ridge | Illinois | 60068 | United States |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202-5289 | United States |
| Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis | Indiana | 46202 | United States |
| Ball Memorial Hospital Cancer Center | Muncie | Indiana | 47303-3499 | United States |
| Porter Memorial Hospital | Valparaiso | Indiana | 46383 | United States |
| Wendt Regional Cancer Center of Finley Hospital | Dubuque | Iowa | 52001 | United States |
| McLaren Regional Cancer Center | Flint | Michigan | 48532-3685 | United States |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia | Missouri | 65203 | United States |
| CCOP - Kansas City | Kansas City | Missouri | 64131 | United States |
| Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha | Omaha | Nebraska | 68114-4199 | United States |
| Norris Cotton Cancer Center at Dartmouth Medical School | Lebanon | New Hampshire | 03756-0002 | United States |
| Monmouth Medical Center | Long Branch | New Jersey | 07740-6395 | United States |
| Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital | Mount Holly | New Jersey | 08060 | United States |
| Fox Chase Cancer Center at St. Francis Medical Center | Trenton | New Jersey | 08629 | United States |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse | New York | 13217 | United States |
| Presbyterian Hospital | Charlotte | North Carolina | 28233-3549 | United States |
| Wayne Memorial Hospital, Inc. | Goldsboro | North Carolina | 27533 | United States |
| Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina | Greenville | North Carolina | 27835-6028 | United States |
| Ireland Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
| CCOP - Dayton | Dayton | Ohio | 45429 | United States |
| CCOP - Toledo Community Hospital | Toledo | Ohio | 43623-3456 | United States |
| St. Luke's Hospital Cancer Center | Bethlehem | Pennsylvania | 18015 | United States |
| Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | 19010 | United States |
| Mercy Fitzgerald Hospital | Darby | Pennsylvania | 19023 | United States |
| Delaware County Memorial Hospital | Drexel Hill | Pennsylvania | 19026 | United States |
| Paoli Memorial Hospital | Paoli | Pennsylvania | 19301-1792 | United States |
| Albert Einstein Cancer Center | Philadelphia | Pennsylvania | 19141-3098 | United States |
| Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | 15224 | United States |
| CCOP - MainLine Health | Wynnewood | Pennsylvania | 19096 | United States |
| Lankenau Cancer Center at Lankenau Hospital | Wynnewood | Pennsylvania | 19096 | United States |
| Greenville Hospital System | Greenville | South Carolina | 29605 | United States |
| CCOP - Greenville | Greenville | South Carolina | 29615 | United States |
| CCOP - Upstate Carolina | Spartanburg | South Carolina | 29303 | United States |
| Rapid City Regional Hospital | Rapid City | South Dakota | 57709 | United States |
| Harrington Cancer Center | Amarillo | Texas | 79106 | United States |
| University of Texas - MD Anderson Cancer Center | Houston | Texas | 77030-4009 | United States |
| McKay-Dee Hospital Center | Ogden | Utah | 84403 | United States |
| Utah Valley Regional Medical Center - Provo | Provo | Utah | 84604 | United States |
| LDS Hospital | Salt Lake City | Utah | 84143 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195-6043 | United States |
| CCOP - Marshfield Clinic Research Foundation | Marshfield | Wisconsin | 54449 | United States |
| Columbia Hospital | Milwaukee | Wisconsin | 53211 | United States |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| D017239 | Paclitaxel |
| D020360 | Neoadjuvant Therapy |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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