Bladder Cancer Clinical Trial
Official title:
A Phase I/II Trial in Patients With Muscle-Invading Bladder Cancer of Transurethral Surgery Plus Taxol, Cisplatin and Bid Irradiation Followed by Either Selective Bladder Preservation or Radical Cystectomy and Adjuvant Chemotherapy
Verified date | October 2015 |
Source | Radiation Therapy Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Radiation therapy uses x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy and surgery may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy plus combination chemotherapy in treating patients who have stage II or stage III bladder cancer that can be removed by surgery.
Status | Completed |
Enrollment | 84 |
Est. completion date | November 2013 |
Est. primary completion date | July 2003 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | DISEASE CHARACTERISTICS: - Histologically confirmed stage II or III (T2-4a, Nx or N0, M0) primary carcinoma of the bladder with muscle invasion - Resectable disease - Prostatic urethral involvement with transitional cell carcinoma allowed, if completely resected and no evidence of stromal invasion - No tumor-related hydronephrosis - Positive lymph node must be evaluated by lymphadenectomy or percutaneous needle biopsy - No nodal metastases - No distant metastases - No more than 6 weeks since prior transurethral resection of the bladder tumor - Functioning bladder PATIENT CHARACTERISTICS: Age: - Adult Performance status: - Zubrod 0-1 Life expectancy: - Not specified Hematopoietic: - Hemoglobin at least 10 g/dL - White blood cell (WBC) count of at least 4,000/mm^3 - Absolute neutrophil count at least 1,800/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 2.0 mg/dL Renal: - Creatinine no greater than 1.5 mg/dL - Creatinine clearance at least 60 mL/min Other: - No other prior or concurrent malignancy within the past 5 years except curatively treated nonmelanoma skin cancer, stage I prostate cancer, or carcinoma in situ of the cervix - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception - Medically operable PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior systemic chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior pelvic radiotherapy Surgery: - See Disease Characteristics Other: - No concurrent potential nephrotoxic or ototoxic drugs (e.g., aminoglycosides) |
Country | Name | City | State |
---|---|---|---|
Canada | Tom Baker Cancer Center - Calgary | Calgary | Alberta |
Canada | Cross Cancer Institute | Edmonton | Alberta |
Canada | CHUS-Hopital Fleurimont | Fleurimont | Quebec |
Canada | Nova Scotia Cancer Centre | Halifax | Nova Scotia |
Canada | Cancer Care Ontario-Hamilton Regional Cancer Centre | Hamilton | Ontario |
Canada | Kingston Regional Cancer Centre | Kingston | Ontario |
Canada | Cancer Care Ontario-London Regional Cancer Centre | London | Ontario |
Canada | Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec |
Canada | McGill University | Montreal | Quebec |
Canada | Ottawa Regional Cancer Centre | Ottawa | Ontario |
Canada | Centre Hospitalier Universitaire de Quebec | Quebec City | Quebec |
Canada | Allan Blair Cancer Centre | Regina | Saskatchewan |
Canada | Saint John Regional Hospital | Saint John | New Brunswick |
Canada | Saskatoon Cancer Centre | Saskatoon | Saskatchewan |
Canada | Newfoundland Cancer Treatment and Research Foundation | St. Johns | Newfoundland and Labrador |
Canada | Northeastern Ontario Regional Cancer Centre, Sudbury | Sudbury | Ontario |
Canada | Northwestern Ontario Regional Cancer Centre, Thunder Bay | Thunder Bay | Ontario |
Canada | Princess Margaret Hospital | Toronto | Ontario |
Canada | Toronto Sunnybrook Regional Cancer Centre | Toronto | Ontario |
United States | Akron City Hospital | Akron | Ohio |
United States | Akron General Medical Center | Akron | Ohio |
United States | Cancer Center of Albany Medical Center | Albany | New York |
United States | Radiation Oncology Associates of Albuquerque | Albuquerque | New Mexico |
United States | Lehigh Valley Hospital | Allentown | Pennsylvania |
United States | Harrington Cancer Center | Amarillo | Texas |
United States | St. John's Medical Center | Anderson | Indiana |
United States | CCOP - Ann Arbor Regional | Ann Arbor | Michigan |
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
United States | Anne Arundel Oncology Center | Annapolis | Maryland |
United States | Northwest Community Hospital | Arlington Heights | Illinois |
United States | CCOP - Atlanta Regional | Atlanta | Georgia |
United States | Emory University Hospital - Atlanta | Atlanta | Georgia |
United States | Greater Baltimore Medical Center and Cancer Center | Baltimore | Maryland |
United States | Harbor Hospital Center | Baltimore | Maryland |
United States | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland |
United States | Sinai Hospital of Baltimore | Baltimore | Maryland |
United States | Mary Bird Perkins Cancer Center | Baton Rouge | Louisiana |
United States | Green Mountain Oncology Group | Bennington | Vermont |
United States | St. Luke's Hospital Regional Cancer Center | Bethlehem | Pennsylvania |
United States | CCOP - Montana Cancer Consortium | Billings | Montana |
United States | University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham | Alabama |
United States | Bloomington Hospital | Bloomington | Indiana |
United States | Massachusetts General Hospital Cancer Center | Boston | Massachusetts |
United States | New York Methodist Hospital | Brooklyn | New York |
United States | State University of New York Health Science Center at Brooklyn | Brooklyn | New York |
United States | Vermont Cancer Center | Burlington | Vermont |
United States | Cooper Cancer Institute | Camden | New Jersey |
United States | Lineberger Comprehensive Cancer Center, UNC | Chapel Hill | North Carolina |
United States | Cancer Center at the University of Virginia | Charlottesville | Virginia |
United States | Northwestern Memorial Hospital | Chicago | Illinois |
United States | Barrett Cancer Center, The University Hospital | Cincinnati | Ohio |
United States | Christ Hospital | Cincinnati | Ohio |
United States | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio |
United States | Ireland Cancer Center | Cleveland | Ohio |
United States | University Hospitals of Cleveland | Cleveland | Ohio |
United States | Finger Lakes Radiation Oncology Center | Clifton Springs | New York |
United States | Memorial Hospital Cancer Center | Colorado Springs | Colorado |
United States | Ellis Fischel Cancer Center - Columbia | Columbia | Missouri |
United States | Arthur G. James Cancer Hospital - Ohio State University | Columbus | Ohio |
United States | CCOP - Columbus | Columbus | Ohio |
United States | Medical Center/John B. Amos Community Cancer Center | Columbus | Georgia |
United States | Mount Diablo Medical Center | Concord | California |
United States | Northeast Medical Center | Concord | North Carolina |
United States | Geisinger Medical Center | Danville | Pennsylvania |
United States | Fitzgerald Mercy Hospital | Darby | Pennsylvania |
United States | CCOP - Central Illinois | Decatur | Illinois |
United States | University of Colorado Cancer Center | Denver | Colorado |
United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | Delaware County Memorial Hospital | Drexel Hill | Pennsylvania |
United States | Cancer Center and Beckman Research Institute, City of Hope | Duarte | California |
United States | Wendt Regional Cancer Center of Finley Hospital | Dubuque | Iowa |
United States | Veterans Affairs Medical Center - East Orange | East Orange | New Jersey |
United States | Pocono Cancer Center | East Stroudsburg | Pennsylvania |
United States | John F. Kennedy Medical Center | Edison | New Jersey |
United States | Trinitas Hospital - Jersey Street Campus | Elizabeth | New Jersey |
United States | Hurley Medical Center | Flint | Michigan |
United States | McLaren Regional Cancer Center | Flint | Michigan |
United States | California Cancer Center | Fresno | California |
United States | Saint Agnes Cancer Center | Fresno | California |
United States | University of Florida Health Science Center | Gainesville | Florida |
United States | University of Texas Medical Branch | Galveston | Texas |
United States | Saint Mary's Hospital and Medical Center | Grand Junction | Colorado |
United States | St. Vincent Hospital | Green Bay | Wisconsin |
United States | Sutter Health West Cancer Research Group | Greenbrae | California |
United States | CCOP - Greenville | Greenville | South Carolina |
United States | East Carolina University School of Medicine | Greenville | North Carolina |
United States | RMH Regional Cancer Center | Harrisonburg | Virginia |
United States | Ingalls Memorial Hospital | Harvey | Illinois |
United States | Milton S. Hershey Medical Center | Hershey | Pennsylvania |
United States | MBCCOP - Hawaii | Honolulu | Hawaii |
United States | University of Texas - MD Anderson Cancer Center | Houston | Texas |
United States | Comprehensive Cancer Institute of Huntsville | Huntsville | Alabama |
United States | Huntsville Hospital System | Huntsville | Alabama |
United States | Cape Cod Hospital | Hyannis | Massachusetts |
United States | Clarian Health Partners Inc. | Indianapolis | Indiana |
United States | Community Hospitals of Indianapolis - Regional Cancer Center | Indianapolis | Indiana |
United States | Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis | Indiana |
United States | Jackson-Madison County General Hospital | Jackson | Tennessee |
United States | Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain | Massachusetts |
United States | CCOP - Kalamazoo | Kalamazoo | Michigan |
United States | CCOP - Kansas City | Kansas City | Missouri |
United States | CCOP - Dayton | Kettering | Ohio |
United States | Gundersen Lutheran Medical Foundation | La Crosse | Wisconsin |
United States | Wilford Hall - 59th Medical Wing | Lackland Air Force Base | Texas |
United States | CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada |
United States | Norris Cotton Cancer Center | Lebanon | New Hampshire |
United States | Albert B. Chandler Medical Center, University of Kentucky | Lexington | Kentucky |
United States | Central Baptist Hospital | Lexington | Kentucky |
United States | Loma Linda University Medical Center | Loma Linda | California |
United States | Veterans Affairs Medical Center - Long Beach | Long Beach | California |
United States | Monmouth Medical Center | Long Branch | New Jersey |
United States | Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California |
United States | USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California |
United States | James Graham Brown Cancer Center | Louisville | Kentucky |
United States | Louisville Radiation Oncology | Louisville | Kentucky |
United States | Joe Arrington Cancer Research and Treatment Center | Lubbock | Texas |
United States | Southern Wisconsin Radiotherapy Center | Madison | Wisconsin |
United States | University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin |
United States | Merle M. Mahr Cancer Center | Madisonville | Kentucky |
United States | Elliot Regional Cancer Center | Manchester | New Hampshire |
United States | CCOP - North Shore University Hospital | Manhasset | New York |
United States | Marquette General Hospital | Marquette | Michigan |
United States | Marshfield Clinic | Marshfield | Wisconsin |
United States | Loyola University Medical Center | Maywood | Illinois |
United States | Health First Holmes Regional Medical Center | Melbourne | Florida |
United States | University of Tennessee, Memphis Cancer Center | Memphis | Tennessee |
United States | Community Memorial Hospital | Menomonee Falls | Wisconsin |
United States | Baptist Hospital of Miami | Miami | Florida |
United States | Sylvester Cancer Center, University of Miami | Miami | Florida |
United States | Veterans Affairs Medical Center - Miami | Miami | Florida |
United States | CCOP - Mount Sinai Medical Center | Miami Beach | Florida |
United States | MidMichigan Medical Center - Midland | Midland | Michigan |
United States | South Jersey Regional Cancer Center | Millville | New Jersey |
United States | Columbia Hospital | Milwaukee | Wisconsin |
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | St. Luke's Medical Center | Milwaukee | Wisconsin |
United States | Trinity Cancer Care Center | Minot | North Dakota |
United States | MBCCOP - Gulf Coast | Mobile | Alabama |
United States | Alabama Oncology, LLC | Montgomery | Alabama |
United States | Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County | Mount Holly | New Jersey |
United States | Ball Memorial Hospital | Muncie | Indiana |
United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
United States | Cancer Institute of New Jersey | New Brunswick | New Jersey |
United States | CCOP - Ochsner | New Orleans | Louisiana |
United States | MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana |
United States | Tulane University School of Medicine | New Orleans | Louisiana |
United States | Herbert Irving Comprehensive Cancer Center | New York | New York |
United States | Newark Beth Israel Medical Center | Newark | New Jersey |
United States | CCOP - Bay Area Tumor Institute | Oakland | California |
United States | St. Anthony Hospital | Oklahoma City | Oklahoma |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | Methodist Cancer Center - Omaha | Omaha | Nebraska |
United States | Nebraska Health System | Omaha | Nebraska |
United States | Florida Radiation Oncology Group | Orange Park | Florida |
United States | MD Anderson Cancer Center Orlando | Orlando | Florida |
United States | Bay Medical Center | Panama City | Florida |
United States | Gulf Coast Cancer Treatment Center | Panama City | Florida |
United States | Lutheran General Cancer Care Center | Park Ridge | Illinois |
United States | Bayshore Medical Center | Pasadena | Texas |
United States | Huntington Cancer Center | Pasadena | California |
United States | Methodist Medical Center of Illinois | Peoria | Illinois |
United States | Albert Einstein Cancer Center | Philadelphia | Pennsylvania |
United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
United States | Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania |
United States | University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania |
United States | Veterans Affairs Medical Center - Philadelphia | Philadelphia | Pennsylvania |
United States | Foundation for Cancer Research and Education | Phoenix | Arizona |
United States | Mercy Hospital of Pittsburgh | Pittsburgh | Pennsylvania |
United States | University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania |
United States | Western Pennsylvania Hospital | Pittsburgh | Pennsylvania |
United States | Champlain Valley Physicians Hospital Medical Center | Plattsburgh | New York |
United States | Atlantic City Medical Center | Pomona | New Jersey |
United States | Cancer Care Center | Pomona | California |
United States | CCOP - Columbia River Program | Portland | Oregon |
United States | Maine Medical Center | Portland | Maine |
United States | Naval Medical Center, Portsmouth | Portsmouth | Virginia |
United States | Vassar Brothers Hospital | Poughkeepsie | New York |
United States | Roger Williams Medical Center/BUSM | Providence | Rhode Island |
United States | Southeastern Wisconsin Regional Cancer Center | Racine | Wisconsin |
United States | Rapid City Regional Hospital | Rapid City | South Dakota |
United States | Reading Hospital and Medical Center | Reading | Pennsylvania |
United States | Bon-Secours - St. Mary's Hospital | Richmond | Virginia |
United States | Massey Cancer Center | Richmond | Virginia |
United States | Valley Hospital | Ridgewood | New Jersey |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | University of Rochester Cancer Center | Rochester | New York |
United States | Regional Radiation Oncology Center at Rome | Rome | Georgia |
United States | William Beaumont Hospital | Royal Oak | Michigan |
United States | Radiation Oncology Center - Sacramento | Sacramento | California |
United States | Dixie Regional Medical Center | Saint George | Utah |
United States | Mallinckrodt Institute of Radiology | Saint Louis | Missouri |
United States | St. Louis University Health Sciences Center | Saint Louis | Missouri |
United States | CCOP - Metro-Minnesota | Saint Louis Park | Minnesota |
United States | Peninsula Regional Medical Center | Salisbury | Maryland |
United States | Latter Day Saints Hospital | Salt Lake City | Utah |
United States | University of Utah Health Sciences Center | Salt Lake City | Utah |
United States | Radiation Medical Group, Inc. | San Diego | California |
United States | UCSF Cancer Center and Cancer Research Institute | San Francisco | California |
United States | O'Connor Hospital | San Jose | California |
United States | CCOP - Santa Rosa Memorial Hospital | Santa Rosa | California |
United States | Sarasota Radiation and Medical Oncology Center | Sarasota | Florida |
United States | Mercy Hospital Cancer Center - Scranton | Scranton | Pennsylvania |
United States | Virginia Mason Medical Center | Seattle | Washington |
United States | CCOP - Northern Indiana CR Consortium | South Bend | Indiana |
United States | CCOP - Upstate Carolina | Spartanburg | South Carolina |
United States | Deaconess Medical Center | Spokane | Washington |
United States | Cancer Research for the Ozarks | Springfield | Missouri |
United States | CCOP - Cancer Research for the Ozarks | Springfield | Missouri |
United States | CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse | New York |
United States | Tallahassee Memorial Healthcare | Tallahassee | Florida |
United States | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida |
United States | CCOP - Toledo Community Hospital Oncology Program | Toledo | Ohio |
United States | Community Medical Center | Toms River | New Jersey |
United States | David Grant Medical Center | Travis Air Force Base | California |
United States | St. Francis Medical Center | Trenton | New Jersey |
United States | William Beaumont Hospital - Troy | Troy | Michigan |
United States | St. John Health System | Tulsa | Oklahoma |
United States | Radiation Oncology Associates of West Alabama | Tuscaloosa | Alabama |
United States | Associated Radiologists, P.A. | Warren | New Jersey |
United States | Waukesha Memorial Hospital | Waukesha | Wisconsin |
United States | Schiffler Cancer Center | Wheeling | West Virginia |
United States | Wilkes Barre General Hospital | Wilkes-Barre | Pennsylvania |
United States | CCOP - Christiana Care Health Services | Wilmington | Delaware |
United States | CCOP - Southeast Cancer Control Consortium | Winston-Salem | North Carolina |
United States | Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina |
United States | Yakima Valley Memorial Hospital | Yakima | Washington |
United States | Riverhill Radiation Oncology | Yonkers | New York |
United States | York Hospital | York | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Radiation Therapy Oncology Group | National Cancer Institute (NCI) |
United States, Canada,
Efstathiou JA, Bae K, Shipley WU, Kaufman DS, Hagan MP, Heney NM, Sandler HM. Late pelvic toxicity after bladder-sparing therapy in patients with invasive bladder cancer: RTOG 89-03, 95-06, 97-06, 99-06. J Clin Oncol. 2009 Sep 1;27(25):4055-61. doi: 10.1200/JCO.2008.19.5776. Epub 2009 Jul 27. — View Citation
Kaufman DS, Winter KA, Shipley WU, et al.: Muscle-invading bladder cancer, RTOG Protocol 99-06: initial report of a phase I/II trial of selective bladder-conservation employing TURBT, accelerated irradiation sensitized with cisplatin and paclitaxel follow
Kaufman DS, Winter KA, Shipley WU, Heney NM, Wallace HJ 3rd, Toonkel LM, Zietman AL, Tanguay S, Sandler HM. Phase I-II RTOG study (99-06) of patients with muscle-invasive bladder cancer undergoing transurethral surgery, paclitaxel, cisplatin, and twice-da — View Citation
Shipley WU, Bae K, Efstathiou JA, et al.: Late pelvic toxicity following bladder-sparing therapy in patients with invasive bladder cancer: analysis of RTOG 89-03, 95-06, 97-06, 99-06. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-14, S8, 2007.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Completion and safety of induction chemo-radiotherapy followed by definitive local therapy of either radical cystectomy or consolidation TCI, followed by four cycles of outpatient adjuvant gemcitabine-cisplatin chemotherapy. | Completion and safety of induction chemo-radiotherapy (cisplatin, paclitaxel and irradiation [TCI]) followed by definitive local therapy of either radical cystectomy (for patients for whom the initial tumor is not a complete response) or consolidation TCI (for patients for whom the initial tumor has cleared), followed by four cycles of outpatient adjuvant gemcitabine-cisplatin chemotherapy. | From start to end of all protocol therapy | |
Secondary | Complete response after TCI induction | From start to end of all protocol therapy | ||
Secondary | Completion and safety of the four cycles of gemcitabine-cisplatin chemotherapy | From start to end of all protocol therapy | ||
Secondary | Invasive local treatment failure | From start of protocol treatment to date of local failure. Analysis occurs after all patients have copmleted treatment. | ||
Secondary | Distant metastasis | From start of protocol treatment to date of distant metastasis | ||
Secondary | To examine the value of tumor histopathology, molecular genetics and DNA flow cytometric parameters as possible significant prognostic factors for initial tumor response and recurrence-free survival. | From the start of protocol treatment to the date the last patient has completed treatment. Analysis occurs after all patients have completed treatment. |
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