Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00003930
First received: November 1, 1999
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Bladder Cancer
Drug: cisplatin
Drug: gemcitabine hydrochloride
Drug: paclitaxel
Procedure: conventional surgery
Radiation: radiation therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • 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. [ Time Frame: From start to end of all protocol therapy ] [ Designated as safety issue: No ]
    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:
  • Complete response after TCI induction [ Time Frame: From start to end of all protocol therapy ] [ Designated as safety issue: No ]
  • Completion and safety of the four cycles of gemcitabine-cisplatin chemotherapy [ Time Frame: From start to end of all protocol therapy ] [ Designated as safety issue: No ]
  • Invasive local treatment failure [ Time Frame: From start of protocol treatment to date of local failure. Analysis occurs after all patients have copmleted treatment. ] [ Designated as safety issue: No ]
  • Distant metastasis [ Time Frame: From start of protocol treatment to date of distant metastasis ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: From the start of protocol treatment to the date the last patient has completed treatment. Analysis occurs after all patients have completed treatment. ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: September 1999
Study Completion Date: November 2013
Primary Completion Date: July 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Transurethral surgery with chemotherapy and radiation therapy followed by either selective bladder preservation or radical cystectomy followed by adjuvant chemotherapy.
Drug: cisplatin Drug: gemcitabine hydrochloride Drug: paclitaxel Procedure: conventional surgery Radiation: radiation therapy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003930

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
Comprehensive Cancer Institute of Huntsville
Huntsville, Alabama, United States, 35801
Huntsville Hospital System
Huntsville, Alabama, United States, 35801-4470
MBCCOP - Gulf Coast
Mobile, Alabama, United States, 36688
Alabama Oncology, LLC
Montgomery, Alabama, United States, 36106-2801
Radiation Oncology Associates of West Alabama
Tuscallosa, Alabama, United States, 35401
United States, Arizona
Foundation for Cancer Research and Education
Phoenix, Arizona, United States, 85013
United States, California
Mount Diablo Medical Center
Concord, California, United States, 94524-4110
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, United States, 91010-3000
California Cancer Center
Fresno, California, United States, 93720
Saint Agnes Cancer Center
Fresno, California, United States, 93720
Sutter Health West Cancer Research Group
Greenbrae, California, United States, 94904
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Veterans Affairs Medical Center - Long Beach
Long Beach, California, United States, 90822
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609-3305
Huntington Cancer Center
Pasadena, California, United States, 91105
Cancer Care Center
Pomona, California, United States, 91767
Radiation Oncology Center - Sacramento
Sacramento, California, United States, 95816
Radiation Medical Group, Inc.
San Diego, California, United States, 92101-1492
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States, 94143-0128
O'Connor Hospital
San Jose, California, United States, 95128
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States, 95403
David Grant Medical Center
Travis Air Force Base, California, United States, 94535
United States, Colorado
Memorial Hospital Cancer Center
Colorado Springs, Colorado, United States, 80909
University of Colorado Cancer Center
Denver, Colorado, United States, 80010
Saint Mary's Hospital and Medical Center
Grand Junction, Colorado, United States, 81502
United States, Delaware
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States, 19899
United States, Florida
University of Florida Health Science Center
Gainesville, Florida, United States, 32610-0296
Health First Holmes Regional Medical Center
Melbourne, Florida, United States, 32901
Baptist Hospital of Miami
Miami, Florida, United States, 33176-2197
Sylvester Cancer Center, University of Miami
Miami, Florida, United States, 33136
Veterans Affairs Medical Center - Miami
Miami, Florida, United States, 33125
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Florida Radiation Oncology Group
Orange Park, Florida, United States, 32073
MD Anderson Cancer Center Orlando
Orlando, Florida, United States, 32806
Gulf Coast Cancer Treatment Center
Panama City, Florida, United States, 32405-4587
Bay Medical Center
Panama City, Florida, United States, 32401
Sarasota Radiation and Medical Oncology Center
Sarasota, Florida, United States, 34233
Tallahassee Memorial Healthcare
Tallahassee, Florida, United States, 32308
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
United States, Georgia
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342-1701
Emory University Hospital - Atlanta
Atlanta, Georgia, United States, 30322
Medical Center/John B. Amos Community Cancer Center
Columbus, Georgia, United States, 31902
Regional Radiation Oncology Center at Rome
Rome, Georgia, United States, 30165
United States, Hawaii
MBCCOP - Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
Northwest Community Hospital
Arlington Heights, Illinois, United States, 60005
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
United States, Indiana
St. John's Medical Center
Anderson, Indiana, United States, 46016
Bloomington Hospital
Bloomington, Indiana, United States, 47402
Clarian Health Partners Inc.
Indianapolis, Indiana, United States, 46206-1367
Community Hospitals of Indianapolis - Regional Cancer Center
Indianapolis, Indiana, United States, 46219
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, United States, 46202
Ball Memorial Hospital
Muncie, Indiana, United States, 47303-3499
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
United States, Iowa
Wendt Regional Cancer Center of Finley Hospital
Dubuque, Iowa, United States, 52001
United States, Kentucky
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States, 40536-0084
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
Louisville Radiation Oncology
Louisville, Kentucky, United States, 40215
Merle M. Mahr Cancer Center
Madisonville, Kentucky, United States, 42431
United States, Louisiana
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
United States, Maryland
Anne Arundel Oncology Center
Annapolis, Maryland, United States, 21401
Greater Baltimore Medical Center and Cancer Center
Baltimore, Maryland, United States, 21204
Harbor Hospital Center
Baltimore, Maryland, United States, 21225
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21225
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Peninsula Regional Medical Center
Salisbury, Maryland, United States, 21801
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Cape Cod Hospital
Hyannis, Massachusetts, United States, 02601
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, United States, 02130
United States, Michigan
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States, 48106
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0752
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Hurley Medical Center
Flint, Michigan, United States, 48503
McLaren Regional Cancer Center
Flint, Michigan, United States, 48432
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
Marquette General Hospital
Marquette, Michigan, United States, 49855
MidMichigan Medical Center - Midland
Midland, Michigan, United States, 48670
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
William Beaumont Hospital - Troy
Troy, Michigan, United States, 48098
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United States, Missouri
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States, 65203
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
St. Louis University Health Sciences Center
Saint Louis, Missouri, United States, 63110-0250
Mallinckrodt Institute of Radiology
Saint Louis, Missouri, United States, 63108
Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
United States, Nebraska
Methodist Cancer Center - Omaha
Omaha, Nebraska, United States, 68114
Nebraska Health System
Omaha, Nebraska, United States, 68198-7460
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756-0002
Elliot Regional Cancer Center
Manchester, New Hampshire, United States, 03103
United States, New Jersey
Cooper Cancer Institute
Camden, New Jersey, United States, 08103
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States, 07018-1095
John F. Kennedy Medical Center
Edison, New Jersey, United States, 08818
Trinitas Hospital - Jersey Street Campus
Elizabeth, New Jersey, United States, 07201
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740-6395
South Jersey Regional Cancer Center
Millville, New Jersey, United States, 08332
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
Mount Holly, New Jersey, United States, 08060
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Atlantic City Medical Center
Pomona, New Jersey, United States, 08240
Valley Hospital
Ridgewood, New Jersey, United States, 07450
Community Medical Center
Toms River, New Jersey, United States, 08755
St. Francis Medical Center
Trenton, New Jersey, United States, 08629
Associated Radiologists, P.A.
Warren, New Jersey, United States, 07059
United States, New Mexico
Radiation Oncology Associates of Albuquerque
Albuquerque, New Mexico, United States, 87109
United States, New York
Cancer Center of Albany Medical Center
Albany, New York, United States, 12208
New York Methodist Hospital
Brooklyn, New York, United States, 11215-3609
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, United States, 11203
Finger Lakes Radiation Oncology Center
Clifton Springs, New York, United States, 14432
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Champlain Valley Physicians Hospital Medical Center
Plattsburgh, New York, United States, 12901
Vassar Brothers Hospital
Poughkeepsie, New York, United States, 12601
University of Rochester Cancer Center
Rochester, New York, United States, 14642
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States, 13217
Riverhill Radiation Oncology
Yonkers, New York, United States, 10701
United States, North Carolina
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
Northeast Medical Center
Concord, North Carolina, United States, 28025
East Carolina University School of Medicine
Greenville, North Carolina, United States, 27858-4354
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States, 27104-4241
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
United States, North Dakota
Trinity Cancer Care Center
Minot, North Dakota, United States, 58701
United States, Ohio
Akron City Hospital
Akron, Ohio, United States, 44309
Akron General Medical Center
Akron, Ohio, United States, 44302
Christ Hospital
Cincinnati, Ohio, United States, 45219
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, United States, 45267-0502
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
CCOP - Columbus
Columbus, Ohio, United States, 43206
CCOP - Dayton
Kettering, Ohio, United States, 45429
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, United States, 43623-3456
United States, Oklahoma
St. Anthony Hospital
Oklahoma City, Oklahoma, United States, 73101
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73190
St. John Health System
Tulsa, Oklahoma, United States, 74104
United States, Oregon
CCOP - Columbia River Program
Portland, Oregon, United States, 97213
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
St. Luke's Hospital Regional Cancer Center
Bethlehem, Pennsylvania, United States, 18015
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Fitzgerald Mercy Hospital
Darby, Pennsylvania, United States, 19023
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States, 19026
Pocono Cancer Center
East Stroudsburg, Pennsylvania, United States, 18301
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Veterans Affairs Medical Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19104
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104-4283
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213-3489
Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15219
Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, United States, 18501
Wilkes Barre General Hospital
Wilkes-Barre, Pennsylvania, United States, 18764
York Hospital
York, Pennsylvania, United States, 17315
United States, Rhode Island
Roger Williams Medical Center/BUSM
Providence, Rhode Island, United States, 02908-4735
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57709
United States, Tennessee
Jackson-Madison County General Hospital
Jackson, Tennessee, United States, 38301
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, United States, 38103
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Texas
Harrington Cancer Center
Amarillo, Texas, United States, 79106
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0209
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Wilford Hall - 59th Medical Wing
Lackland Air Force Base, Texas, United States, 78236-5300
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79410-1894
Bayshore Medical Center
Pasadena, Texas, United States, 77504
United States, Utah
Dixie Regional Medical Center
Saint George, Utah, United States, 84770
Latter Day Saints Hospital
Salt Lake City, Utah, United States, 84143
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84132
United States, Vermont
Green Mountain Oncology Group
Bennington, Vermont, United States, 05201
Vermont Cancer Center
Burlington, Vermont, United States, 05401-3498
United States, Virginia
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
RMH Regional Cancer Center
Harrisonburg, Virginia, United States, 22801
Naval Medical Center, Portsmouth
Portsmouth, Virginia, United States, 23708-2197
Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
Bon-Secours - St. Mary's Hospital
Richmond, Virginia, United States, 23226
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98111
Deaconess Medical Center
Spokane, Washington, United States, 99210-0248
Yakima Valley Memorial Hospital
Yakima, Washington, United States, 98902
United States, West Virginia
Schiffler Cancer Center
Wheeling, West Virginia, United States, 26003
United States, Wisconsin
St. Vincent Hospital
Green Bay, Wisconsin, United States, 54307-3508
Gundersen Lutheran Medical Foundation
La Crosse, Wisconsin, United States, 54601
Southern Wisconsin Radiotherapy Center
Madison, Wisconsin, United States, 53713
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Community Memorial Hospital
Menomonee Falls, Wisconsin, United States, 53051
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Columbia Hospital
Milwaukee, Wisconsin, United States, 53211
Southeastern Wisconsin Regional Cancer Center
Racine, Wisconsin, United States, 53405
Waukesha Memorial Hospital
Waukesha, Wisconsin, United States, 53188
Canada, Alberta
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, New Brunswick
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
Newfoundland Cancer Treatment and Research Foundation
St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Kingston Regional Cancer Centre
Kingston, Ontario, Canada, K7L 5P9
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 1C4
Northeastern Ontario Regional Cancer Centre, Sudbury
Sudbury, Ontario, Canada, P3E 5J1
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, Canada, P7A 7T1
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
CHUS-Hopital Fleurimont
Fleurimont, Quebec, Canada, J1H 5N4
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2L-4M1
McGill University
Montreal, Quebec, Canada, H2W 1S6
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, Canada, G1R 2J6
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Donald S. Kaufman, MD Massachusetts General Hospital
  More Information

Additional Information:
Publications:
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 followed by adjuvant cisplatin and gemcitabine chemotherapy. [Abstract] J Clin Oncol 23 (Suppl 16): A-4506, 379s, 2005.
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.

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00003930     History of Changes
Other Study ID Numbers: RTOG-9906, CDR0000067122, RTOG-DEV-14321
Study First Received: November 1, 1999
Last Updated: May 9, 2014
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
stage II bladder cancer
stage III bladder cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Gemcitabine
Cisplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 21, 2014