Gastric Cancer Clinical Trial
Official title:
A Randomized Phase II Comparison Of Two Cisplatin-Paclitaxel Containing Chemoradiation Regimens In Resected Gastric Cancers
Verified date | November 2015 |
Source | Radiation Therapy Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | May 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed stage IB-IIIB adenocarcinoma of the stomach or gastroesophageal junction having undergone potentially curative resection of primary tumor - No more than 8 weeks since primary tumor resection - No metastatic disease PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - Zubrod 0-1 Life expectancy: - Not specified Hematopoietic: - WBC (white blood cell count) at least 4,000/mm^3 - Platelet count at least 150,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 mg/dL - AST (aspartate aminotransferase) and ALT (alanine amino transferase) no greater than 2.5 times upper limit of normal Renal: - BUN(blood urea nitrogen)less than 30 mg/dL - Creatinine no greater than 1.4 mg/dL - Creatinine clearance greater than 50 mL/min Cardiovascular: - No New York Heart Association class III or IV heart disease - No active angina or myocardial infarction within the past 6 months - No history of significant ventricular arrhythmia requiring medication with antiarrhythmics - No history of clinically significant conduction system abnormality Other: - No concurrent serious infection that is uncontrolled or would preclude study participation - No nonmalignant medical illness that is uncontrolled or would preclude study participation - No psychiatric disorders that would preclude study participation - No other active malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix - No clinically significant hearing loss - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy - No other concurrent chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy to the treatment field Surgery: - See Disease Characteristics Other: - No other concurrent anticancer therapy |
Allocation: Randomized, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Akron City Hospital - Summa Health System | Akron | Ohio |
United States | Akron General Medical Center | Akron | Ohio |
United States | John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital | Allentown | Pennsylvania |
United States | Providence Alaska Medical Center | Anchorage | Alaska |
United States | University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham | Alabama |
United States | Cancer Research Center at Boston Medical Center | Boston | Massachusetts |
United States | New York Methodist Hospital | Brooklyn | New York |
United States | Bryn Mawr Hospital | Bryn Mawr | Pennsylvania |
United States | Providence Saint Joseph Medical Center - Burbank | Burbank | California |
United States | Ireland Cancer Center | Cleveland | Ohio |
United States | Memorial Hospital Cancer Center | Colorado Springs | Colorado |
United States | Mercy Fitzgerald Hospital | Darby | Pennsylvania |
United States | CCOP - Dayton | Dayton | Ohio |
United States | University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver | Colorado |
United States | Delaware County Memorial Hospital | Drexel Hill | Pennsylvania |
United States | City of Hope Comprehensive Cancer Center | Duarte | California |
United States | Wendt Regional Cancer Center of Finley Hospital | Dubuque | Iowa |
United States | Pocono Cancer Center | East Stroudsburg | Pennsylvania |
United States | John F. Kennedy Medical Center | Edison | New Jersey |
United States | Alexian Brothers Cancer Care Center | Elk Grove Village | Illinois |
United States | Blanchard Valley Medical Associates | Findlay | Ohio |
United States | Wayne Memorial Hospital, Inc. | Goldsboro | North Carolina |
United States | CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay | Wisconsin |
United States | St. Vincent Hospital | Green Bay | Wisconsin |
United States | Sutter Health Western Division Cancer Research Group | Greenbrae | California |
United States | University of Texas - MD Anderson Cancer Center | Houston | Texas |
United States | CCOP - Kansas City | Kansas City | Missouri |
United States | Cancer Center at Lexington Clinic | Lexington | Kentucky |
United States | Lima Memorial Hospital | Lima | Ohio |
United States | Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda | California |
United States | CCOP - Marshfield Clinic Research Foundation | Marshfield | Wisconsin |
United States | Baptist Hospital of Miami | Miami | Florida |
United States | Columbia Hospital | Milwaukee | Wisconsin |
United States | Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin |
United States | St. Luke's Medical Center | Milwaukee | Wisconsin |
United States | Mobile Infirmary Medical Center | Mobile | Alabama |
United States | Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital | Mount Holly | New Jersey |
United States | Cottonwood Hospital Medical Center | Murray | Utah |
United States | Yale Comprehensive Cancer Center | New Haven | Connecticut |
United States | CCOP - Bay Area Tumor Institute | Oakland | California |
United States | McKay-Dee Hospital Center | Ogden | Utah |
United States | Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha | Omaha | Nebraska |
United States | St. Charles Hospital | Oregon | Ohio |
United States | Paoli Memorial Hospital | Paoli | Pennsylvania |
United States | Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania |
United States | Foundation for Cancer Research and Education | Phoenix | Arizona |
United States | Western Pennsylvania Hospital | Pittsburgh | Pennsylvania |
United States | Highland Hospital of Rochester | Rochester | New York |
United States | James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York |
United States | Rutherford Hospital | Rutherfordton | North Carolina |
United States | University of California Davis Cancer Center | Sacramento | California |
United States | Dixie Regional Medical Center | Saint George | Utah |
United States | Siteman Cancer Center | Saint Louis | Missouri |
United States | CCOP - Metro-Minnesota | Saint Louis Park | Minnesota |
United States | Cancer Care Center, Incorporated | Salem | Ohio |
United States | LDS Hospital | Salt Lake City | Utah |
United States | University of Utah Health Sciences Center | Salt Lake City | Utah |
United States | Firelands Regional Medical Center | Sandusky | Ohio |
United States | CCOP - Santa Rosa Memorial Hospital | Santa Rosa | California |
United States | University of Washington Medical Center | Seattle | Washington |
United States | CCOP - Upstate Carolina | Spartanburg | South Carolina |
United States | Flower Hospital - ProMedica Health System | Sylvania | Ohio |
United States | CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse | New York |
United States | CCOP - Toledo Community Hospital | Toledo | Ohio |
United States | Medical College of Ohio Cancer Institute | Toledo | Ohio |
United States | Community Medical Center | Toms River | New Jersey |
United States | Natalie Warren Bryant Cancer Center | Tulsa | Oklahoma |
United States | Fulton County Health Center | Wauseon | Ohio |
United States | Lankenau Cancer Center at Lankenau Hospital | Wynnewood | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Radiation Therapy Oncology Group | National Cancer Institute (NCI) |
United States,
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
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 Intergroup #0114). [Abstract] J Clin Oncol 23 (Su
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 — View Citation
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