Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer
- Conditions
- Bladder Cancer
- Interventions
- Procedure: conventional surgeryRadiation: radiation therapy
- Registration Number
- NCT00003930
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* Evaluate the safety and tolerability of induction chemoradiotherapy with paclitaxel and cisplatin followed by selective bladder preservation or radical cystectomy and adjuvant chemotherapy in patients with stage II or III muscle invasive carcinoma of the bladder previously treated with transurethral tumor resection.
* Evaluate the efficacy of transurethral tumor resection and induction chemoradiotherapy in achieving a complete response in this patient population.
* Assess the value of tumor parameters as prognostic factors for initial tumor response and recurrence-free survival in this patient population.
OUTLINE: Four to six weeks after prior transurethral resection, patients receive induction therapy comprising paclitaxel IV over 1 hour on days 1, 8, and 15, cisplatin IV over 1 hour on days 1, 2, 8, 9, 15, and 16, and radiotherapy twice daily on days 1-5, 8-12, and 17.
Four weeks after induction therapy, patients undergo urologic evaluation. At 1-2 weeks after evaluation, patients with complete response receive consolidation therapy comprising paclitaxel IV over 1 hour on days 1 and 8, cisplatin IV over 1 hour on days 1, 2, 8, and 9, and radiotherapy twice daily on days 1-5 and 8-10. Patients with poor tumor response undergo a cystectomy.
At 12 weeks postconsolidation therapy or 8 weeks post radical cystectomy, patients receive adjuvant chemotherapy comprising gemcitabine IV over 30-60 minutes followed by cisplatin IV over 1 hour every 3 weeks. Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 84 patients will be accrued for this study within 3 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 radiation therapy Transurethral surgery with chemotherapy and radiation therapy followed by either selective bladder preservation or radical cystectomy followed by adjuvant chemotherapy. Arm 1 conventional surgery Transurethral surgery with chemotherapy and radiation therapy followed by either selective bladder preservation or radical cystectomy followed by adjuvant chemotherapy. Arm 1 gemcitabine hydrochloride Transurethral surgery with chemotherapy and radiation therapy followed by either selective bladder preservation or radical cystectomy followed by adjuvant chemotherapy. Arm 1 cisplatin Transurethral surgery with chemotherapy and radiation therapy followed by either selective bladder preservation or radical cystectomy followed by adjuvant chemotherapy. Arm 1 paclitaxel Transurethral surgery with chemotherapy and radiation therapy followed by either selective bladder preservation or radical cystectomy followed by adjuvant chemotherapy.
- Primary Outcome Measures
Name Time Method 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. From start to end of all protocol therapy 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.
- Secondary Outcome Measures
Name Time Method 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. Invasive local treatment failure From start of protocol treatment to date of local failure. Analysis occurs after all patients have copmleted treatment. Complete response after TCI induction From start to end of all protocol therapy Completion and safety of the four cycles of gemcitabine-cisplatin chemotherapy From start to end of all protocol therapy Distant metastasis From start of protocol treatment to date of distant metastasis
Trial Locations
- Locations (229)
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Huntsville Hospital System
🇺🇸Huntsville, Alabama, United States
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States
Sutter Health West Cancer Research Group
🇺🇸Greenbrae, California, United States
Comprehensive Cancer Institute of Huntsville
🇺🇸Huntsville, Alabama, United States
Mount Diablo Medical Center
🇺🇸Concord, California, United States
Alabama Oncology, LLC
🇺🇸Montgomery, Alabama, United States
Radiation Oncology Associates of West Alabama
🇺🇸Tuscaloosa, Alabama, United States
Veterans Affairs Medical Center - Long Beach
🇺🇸Long Beach, California, United States
CCOP - Christiana Care Health Services
🇺🇸Wilmington, Delaware, United States
California Cancer Center
🇺🇸Fresno, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Mary Bird Perkins Cancer Center
🇺🇸Baton Rouge, Louisiana, United States
Ellis Fischel Cancer Center - Columbia
🇺🇸Columbia, Missouri, United States
Saint Mary's Hospital and Medical Center
🇺🇸Grand Junction, Colorado, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
Huntington Cancer Center
🇺🇸Pasadena, California, United States
Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
Albert B. Chandler Medical Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
Ingalls Memorial Hospital
🇺🇸Harvey, Illinois, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
St. John's Medical Center
🇺🇸Anderson, Indiana, United States
Mallinckrodt Institute of Radiology
🇺🇸Saint Louis, Missouri, United States
Vassar Brothers Hospital
🇺🇸Poughkeepsie, New York, United States
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
St. Louis University Health Sciences Center
🇺🇸Saint Louis, Missouri, United States
Herbert Irving Comprehensive Cancer Center
🇺🇸New York, New York, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
St. John Health System
🇺🇸Tulsa, Oklahoma, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
Elliot Regional Cancer Center
🇺🇸Manchester, New Hampshire, United States
Radiation Oncology Associates of Albuquerque
🇺🇸Albuquerque, New Mexico, United States
Akron General Medical Center
🇺🇸Akron, Ohio, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸Syracuse, New York, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Finger Lakes Radiation Oncology Center
🇺🇸Clifton Springs, New York, United States
John F. Kennedy Medical Center
🇺🇸Edison, New Jersey, United States
Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
New York Methodist Hospital
🇺🇸Brooklyn, New York, United States
East Carolina University School of Medicine
🇺🇸Greenville, North Carolina, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
University of Tennessee, Memphis Cancer Center
🇺🇸Memphis, Tennessee, United States
Jackson-Madison County General Hospital
🇺🇸Jackson, Tennessee, United States
Riverhill Radiation Oncology
🇺🇸Yonkers, New York, United States
Ottawa Regional Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Southern Wisconsin Radiotherapy Center
🇺🇸Madison, Wisconsin, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
CHUS-Hopital Fleurimont
🇨🇦Fleurimont, Quebec, Canada
Toronto Sunnybrook Regional Cancer Centre
🇨🇦Toronto, Ontario, Canada
Cancer Center at the University of Virginia
🇺🇸Charlottesville, Virginia, United States
Yakima Valley Memorial Hospital
🇺🇸Yakima, Washington, United States
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
Waukesha Memorial Hospital
🇺🇸Waukesha, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Cancer Care Ontario-Hamilton Regional Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Southeastern Wisconsin Regional Cancer Center
🇺🇸Racine, Wisconsin, United States
Community Memorial Hospital
🇺🇸Menomonee Falls, Wisconsin, United States
Cancer Care Ontario-London Regional Cancer Centre
🇨🇦London, Ontario, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
🇨🇦Thunder Bay, Ontario, Canada
Saint John Regional Hospital
🇨🇦Saint John, New Brunswick, Canada
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
🇨🇦Sudbury, Ontario, Canada
Kingston Regional Cancer Centre
🇨🇦Kingston, Ontario, Canada
Veterans Affairs Medical Center - Miami
🇺🇸Miami, Florida, United States
Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
🇺🇸Indianapolis, Indiana, United States
Community Hospitals of Indianapolis - Regional Cancer Center
🇺🇸Indianapolis, Indiana, United States
Christ Hospital
🇺🇸Cincinnati, Ohio, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
University of Utah Health Sciences Center
🇺🇸Salt Lake City, Utah, United States
Latter Day Saints Hospital
🇺🇸Salt Lake City, Utah, United States
MBCCOP - Hawaii
🇺🇸Honolulu, Hawaii, United States
Trinity Cancer Care Center
🇺🇸Minot, North Dakota, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Foundation for Cancer Research and Education
🇺🇸Phoenix, Arizona, United States
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
St. Anthony Hospital
🇺🇸Oklahoma City, Oklahoma, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
CCOP - Columbia River Program
🇺🇸Portland, Oregon, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Cancer Care Center
🇺🇸Pomona, California, United States
Memorial Hospital Cancer Center
🇺🇸Colorado Springs, Colorado, United States
Wendt Regional Cancer Center of Finley Hospital
🇺🇸Dubuque, Iowa, United States
MBCCOP - LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Cape Cod Hospital
🇺🇸Hyannis, Massachusetts, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
🇺🇸Jamaica Plain, Massachusetts, United States
MidMichigan Medical Center - Midland
🇺🇸Midland, Michigan, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
William Beaumont Hospital - Troy
🇺🇸Troy, Michigan, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
🇺🇸Mount Holly, New Jersey, United States
Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Cancer Center of Albany Medical Center
🇺🇸Albany, New York, United States
State University of New York Health Science Center at Brooklyn
🇺🇸Brooklyn, New York, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
Champlain Valley Physicians Hospital Medical Center
🇺🇸Plattsburgh, New York, United States
Northeast Medical Center
🇺🇸Concord, North Carolina, United States
Methodist Cancer Center - Omaha
🇺🇸Omaha, Nebraska, United States
Nebraska Health System
🇺🇸Omaha, Nebraska, United States
St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Columbia Hospital
🇺🇸Milwaukee, Wisconsin, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
Fitzgerald Mercy Hospital
🇺🇸Darby, Pennsylvania, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Reading Hospital and Medical Center
🇺🇸Reading, Pennsylvania, United States
Wilkes Barre General Hospital
🇺🇸Wilkes-Barre, Pennsylvania, United States
Harrington Cancer Center
🇺🇸Amarillo, Texas, United States
Dixie Regional Medical Center
🇺🇸Saint George, Utah, United States
Green Mountain Oncology Group
🇺🇸Bennington, Vermont, United States
Vermont Cancer Center
🇺🇸Burlington, Vermont, United States
Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Deaconess Medical Center
🇺🇸Spokane, Washington, United States
Tom Baker Cancer Center - Calgary
🇨🇦Calgary, Alberta, Canada
Centre Hospitalier de l'Universite de Montreal
🇨🇦Montreal, Quebec, Canada
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada
McGill University
🇨🇦Montreal, Quebec, Canada
Saint Agnes Cancer Center
🇺🇸Fresno, California, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Radiation Medical Group, Inc.
🇺🇸San Diego, California, United States
O'Connor Hospital
🇺🇸San Jose, California, United States
CCOP - Santa Rosa Memorial Hospital
🇺🇸Santa Rosa, California, United States
David Grant Medical Center
🇺🇸Travis Air Force Base, California, United States
Health First Holmes Regional Medical Center
🇺🇸Melbourne, Florida, United States
University of Florida Health Science Center
🇺🇸Gainesville, Florida, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Sylvester Cancer Center, University of Miami
🇺🇸Miami, Florida, United States
MD Anderson Cancer Center Orlando
🇺🇸Orlando, Florida, United States
Florida Radiation Oncology Group
🇺🇸Orange Park, Florida, United States
Bay Medical Center
🇺🇸Panama City, Florida, United States
Gulf Coast Cancer Treatment Center
🇺🇸Panama City, Florida, United States
Sarasota Radiation and Medical Oncology Center
🇺🇸Sarasota, Florida, United States
Tallahassee Memorial Healthcare
🇺🇸Tallahassee, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
Medical Center/John B. Amos Community Cancer Center
🇺🇸Columbus, Georgia, United States
Northwest Community Hospital
🇺🇸Arlington Heights, Illinois, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Bloomington Hospital
🇺🇸Bloomington, Indiana, United States
Central Baptist Hospital
🇺🇸Lexington, Kentucky, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
Ball Memorial Hospital
🇺🇸Muncie, Indiana, United States
Clarian Health Partners Inc.
🇺🇸Indianapolis, Indiana, United States
James Graham Brown Cancer Center
🇺🇸Louisville, Kentucky, United States
Louisville Radiation Oncology
🇺🇸Louisville, Kentucky, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Merle M. Mahr Cancer Center
🇺🇸Madisonville, Kentucky, United States
Marquette General Hospital
🇺🇸Marquette, Michigan, United States
McLaren Regional Cancer Center
🇺🇸Flint, Michigan, United States
Akron City Hospital
🇺🇸Akron, Ohio, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
CCOP - Dayton
🇺🇸Kettering, Ohio, United States
Barrett Cancer Center, The University Hospital
🇺🇸Cincinnati, Ohio, United States
CCOP - Toledo Community Hospital Oncology Program
🇺🇸Toledo, Ohio, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
St. Luke's Hospital Regional Cancer Center
🇺🇸Bethlehem, Pennsylvania, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Veterans Affairs Medical Center - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Delaware County Memorial Hospital
🇺🇸Drexel Hill, Pennsylvania, United States
Pocono Cancer Center
🇺🇸East Stroudsburg, Pennsylvania, United States
Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Albert Einstein Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Mercy Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Roger Williams Medical Center/BUSM
🇺🇸Providence, Rhode Island, United States
Mercy Hospital Cancer Center - Scranton
🇺🇸Scranton, Pennsylvania, United States
York Hospital
🇺🇸York, Pennsylvania, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
RMH Regional Cancer Center
🇺🇸Harrisonburg, Virginia, United States
Wilford Hall - 59th Medical Wing
🇺🇸Lackland Air Force Base, Texas, United States
Bayshore Medical Center
🇺🇸Pasadena, Texas, United States
St. Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
Bon-Secours - St. Mary's Hospital
🇺🇸Richmond, Virginia, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
University of Rochester Cancer Center
🇺🇸Rochester, New York, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
Radiation Oncology Center - Sacramento
🇺🇸Sacramento, California, 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
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Joe Arrington Cancer Research and Treatment Center
🇺🇸Lubbock, Texas, United States
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
Regional Radiation Oncology Center at Rome
🇺🇸Rome, Georgia, United States
Naval Medical Center, Portsmouth
🇺🇸Portsmouth, Virginia, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Lutheran General Cancer Care Center
🇺🇸Park Ridge, Illinois, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
Atlantic City Medical Center
🇺🇸Pomona, New Jersey, United States
St. Francis Medical Center
🇺🇸Trenton, New Jersey, United States
Greater Baltimore Medical Center and Cancer Center
🇺🇸Baltimore, Maryland, United States
Harbor Hospital Center
🇺🇸Baltimore, Maryland, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
CCOP - Ochsner
🇺🇸New Orleans, Louisiana, United States
Peninsula Regional Medical Center
🇺🇸Salisbury, Maryland, United States
Anne Arundel Oncology Center
🇺🇸Annapolis, Maryland, United States
Associated Radiologists, P.A.
🇺🇸Warren, New Jersey, United States
South Jersey Regional Cancer Center
🇺🇸Millville, New Jersey, United States
Community Medical Center
🇺🇸Toms River, New Jersey, United States
Trinitas Hospital - Jersey Street Campus
🇺🇸Elizabeth, New Jersey, United States
Monmouth Medical Center
🇺🇸Long Branch, New Jersey, United States
Centre Hospitalier Universitaire de Quebec
🇨🇦Quebec City, Quebec, Canada
Schiffler Cancer Center
🇺🇸Wheeling, West Virginia, United States
Nova Scotia Cancer Centre
🇨🇦Halifax, Nova Scotia, Canada
Allan Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada
Newfoundland Cancer Treatment and Research Foundation
🇨🇦St. Johns, Newfoundland and Labrador, Canada
Cancer Center and Beckman Research Institute, City of Hope
🇺🇸Duarte, California, United States
Gundersen Lutheran Medical Foundation
🇺🇸La Crosse, Wisconsin, United States
Cooper Cancer Institute
🇺🇸Camden, New Jersey, United States
Veterans Affairs Medical Center - East Orange
🇺🇸East Orange, New Jersey, United States