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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000068464 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy such as cisplatin and paclitaxel 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. Cisplatin and paclitaxel may make the tumor cells more sensitive to radiation therapy and may kill any tumor cells remaining after surgery.
PURPOSE: Randomized phase II trial to study the effectiveness of cisplatin, paclitaxel, and radiation therapy with or without fluorouracil in treating patients who have stage IB, stage IIB, or stage IIIB stomach cancer that has been removed during surgery.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor stage (T1-2 vs T3 vs T4) and by number of involved lymph nodes (none vs 1-3 vs 4 or more). Patients are randomized to one of two treatment arms. (Arm I closed to accrual as of 6/18/03.)
At 3-4 weeks after completion of chemotherapy, patients receive radiotherapy once daily and fluorouracil IV continuously on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive paclitaxel IV over 3 hours on days 1, 8, 15, 22, and 29.
At 3-4 weeks after completion of chemotherapy, patients receive radiotherapy once daily and paclitaxel IV continuously on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive cisplatin IV over 1 hour on days 1, 8, 15, 22, and 29.
Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 94 patients will be accrued for this study within 3 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | |||
| paclitaxel | Drug | |||
| adjuvant therapy | Procedure | |||
| radiation therapy | Radiation |
DISEASE CHARACTERISTICS:
Histologically confirmed stage IB-IIIB adenocarcinoma of the stomach or gastroesophageal junction having undergone potentially curative resection of primary tumor
No metastatic disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| David Paul Kelsen, MD | Memorial Sloan Kettering Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham | Alabama | 35294-3300 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19273696 | Result | Schwartz GK, Winter K, Minsky BD, Crane C, Thomson PJ, Anne P, Gross H, Willett C, Kelsen D. Randomized phase II trial evaluating two paclitaxel and cisplatin-containing chemoradiation regimens as adjuvant therapy in resected gastric cancer (RTOG-0114). J Clin Oncol. 2009 Apr 20;27(12):1956-62. doi: 10.1200/JCO.2008.20.3745. Epub 2009 Mar 9. | |
| Result | Schwartz GK, Winter K, Minsky B, et al.: A randomized phase II trial comparing two paclitaxel (P)-cisplatin (C) containing chemoradiation (CRT) regimens as adjuvant therapy in resected gastric cancer (RTOG 0114). [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-1069, S169, 2006. |
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| Mobile Infirmary Medical Center |
| Mobile |
| Alabama |
| 36652-2144 |
| United States |
| Providence Alaska Medical Center | Anchorage | Alaska | 99519-6604 | United States |
| Foundation for Cancer Research and Education | Phoenix | Arizona | 85013 | United States |
| Providence Saint Joseph Medical Center - Burbank | Burbank | California | 91505 | United States |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010-3000 | United States |
| Sutter Health Western Division Cancer Research Group | Greenbrae | California | 94904 | United States |
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda | California | 92354 | United States |
| CCOP - Bay Area Tumor Institute | Oakland | California | 94609-3305 | United States |
| University of California Davis Cancer Center | Sacramento | California | 95817 | United States |
| CCOP - Santa Rosa Memorial Hospital | Santa Rosa | California | 95403 | United States |
| Memorial Hospital Cancer Center | Colorado Springs | Colorado | 80909 | United States |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver | Colorado | 80010 | United States |
| Yale Comprehensive Cancer Center | New Haven | Connecticut | 06520-8040 | United States |
| Baptist Hospital of Miami | Miami | Florida | 33256-2110 | United States |
| Alexian Brothers Cancer Care Center | Elk Grove Village | Illinois | 60007 | United States |
| Wendt Regional Cancer Center of Finley Hospital | Dubuque | Iowa | 52001 | United States |
| Cancer Center at Lexington Clinic | Lexington | Kentucky | 40504 | United States |
| Cancer Research Center at Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | United States |
| CCOP - Kansas City | Kansas City | Missouri | 64131 | United States |
| Siteman Cancer Center | St Louis | Missouri | 63110 | United States |
| Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha | Omaha | Nebraska | 68114-4199 | United States |
| John F. Kennedy Medical Center | Edison | New Jersey | 08818 | United States |
| Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital | Mount Holly | New Jersey | 08060 | United States |
| Community Medical Center | Toms River | New Jersey | 08755 | United States |
| New York Methodist Hospital | Brooklyn | New York | 11215 | United States |
| Highland Hospital of Rochester | Rochester | New York | 14620 | United States |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse | New York | 13217 | United States |
| Wayne Memorial Hospital, Inc. | Goldsboro | North Carolina | 27533 | United States |
| Rutherford Hospital | Rutherfordton | North Carolina | 28139-0000 | United States |
| Akron General Medical Center | Akron | Ohio | 44302 | United States |
| Akron City Hospital - Summa Health System | Akron | Ohio | 44304 | United States |
| Ireland Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
| CCOP - Dayton | Dayton | Ohio | 45429 | United States |
| Blanchard Valley Medical Associates | Findlay | Ohio | 45840 | United States |
| Lima Memorial Hospital | Lima | Ohio | 45804 | United States |
| St. Charles Hospital | Oregon | Ohio | 43616 | United States |
| Cancer Care Center, Incorporated | Salem | Ohio | 44460 | United States |
| Firelands Regional Medical Center | Sandusky | Ohio | 44870 | United States |
| Flower Hospital - ProMedica Health System | Sylvania | Ohio | 43560 | United States |
| Medical College of Ohio Cancer Institute | Toledo | Ohio | 43614 | United States |
| CCOP - Toledo Community Hospital | Toledo | Ohio | 43623-3456 | United States |
| Fulton County Health Center | Wauseon | Ohio | 43567 | United States |
| Natalie Warren Bryant Cancer Center | Tulsa | Oklahoma | 74136 | United States |
| John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital | Allentown | Pennsylvania | 18105 | 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 |
| Pocono Cancer Center | East Stroudsburg | Pennsylvania | 18301 | United States |
| Paoli Memorial Hospital | Paoli | Pennsylvania | 19301-1792 | United States |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania | 19107-5541 | United States |
| Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | 15224 | United States |
| Lankenau Cancer Center at Lankenau Hospital | Wynnewood | Pennsylvania | 19096 | United States |
| CCOP - Upstate Carolina | Spartanburg | South Carolina | 29303 | United States |
| University of Texas - MD Anderson Cancer Center | Houston | Texas | 77030-4009 | United States |
| Cottonwood Hospital Medical Center | Murray | Utah | 84107 | United States |
| McKay-Dee Hospital Center | Ogden | Utah | 84403 | United States |
| University of Utah Health Sciences Center | Salt Lake City | Utah | 84132 | United States |
| LDS Hospital | Salt Lake City | Utah | 84143 | United States |
| Dixie Regional Medical Center | St. George | Utah | 84770 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195-6043 | United States |
| CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay | Wisconsin | 54301 | United States |
| St. Vincent Hospital | Green Bay | Wisconsin | 54307-3508 | United States |
| CCOP - Marshfield Clinic Research Foundation | Marshfield | Wisconsin | 54449 | United States |
| Columbia Hospital | Milwaukee | Wisconsin | 53211 | United States |
| St. Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| C562730 | Adenocarcinoma Of Esophagus |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D017239 | Paclitaxel |
| D017024 | Chemotherapy, Adjuvant |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| 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 |
| D004358 | Drug Therapy |
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