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

NCT00003930 | Completed Phase 1 DMC

• 2 other identifiers: RTOG-9906CDR0000067122
• Study Type: interventional
• Target: 84
• Locations: 2 countries
• Sites: 229

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.

Conditions

Bladder Cancer

Keywords

stage II bladder cancer; stage III bladder cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• Invasive local treatment failure

  From start of protocol treatment to date of local failure. Analysis occurs after all patients have copmleted treatment.

• Distant metastasis

  From start of protocol treatment to date of distant metastasis

• 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.

Study Arms (1)

Arm 1

EXPERIMENTAL

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

Interventions

cisplatin DRUG

Arm 1

gemcitabine hydrochloride DRUG

Arm 1

paclitaxel DRUG

Arm 1

conventional surgery PROCEDURE

Arm 1

radiation therapy RADIATION

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (229)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

Huntsville Hospital System

Huntsville, Alabama, 35801-4470, United States

Location

Comprehensive Cancer Institute of Huntsville

Huntsville, Alabama, 35801, United States

Location

MBCCOP - Gulf Coast

Mobile, Alabama, 36688, United States

Location

Alabama Oncology, LLC

Montgomery, Alabama, 36106-2801, United States

Location

Radiation Oncology Associates of West Alabama

Tuscaloosa, Alabama, 35401, United States

Location

Foundation for Cancer Research and Education

Phoenix, Arizona, 85013, United States

Location

Mount Diablo Medical Center

Concord, California, 94524-4110, United States

Location

Cancer Center and Beckman Research Institute, City of Hope

Duarte, California, 91010-3000, United States

Location

California Cancer Center

Fresno, California, 93720, United States

Location

Saint Agnes Cancer Center

Fresno, California, 93720, United States

Location

Sutter Health West Cancer Research Group

Greenbrae, California, 94904, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Veterans Affairs Medical Center - Long Beach

Long Beach, California, 90822, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033-0804, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

CCOP - Bay Area Tumor Institute

Oakland, California, 94609-3305, United States

Location

Huntington Cancer Center

Pasadena, California, 91105, United States

Location

Cancer Care Center

Pomona, California, 91767, United States

Location

Radiation Oncology Center - Sacramento

Sacramento, California, 95816, United States

Location

Radiation Medical Group, Inc.

San Diego, California, 92101-1492, United States

Location

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, 94143-0128, United States

Location

O'Connor Hospital

San Jose, California, 95128, United States

Location

CCOP - Santa Rosa Memorial Hospital

Santa Rosa, California, 95403, United States

Location

David Grant Medical Center

Travis Air Force Base, California, 94535, United States

Location

Memorial Hospital Cancer Center

Colorado Springs, Colorado, 80909, United States

Location

University of Colorado Cancer Center

Denver, Colorado, 80010, United States

Location

Saint Mary's Hospital and Medical Center

Grand Junction, Colorado, 81502, United States

Location

CCOP - Christiana Care Health Services

Wilmington, Delaware, 19899, United States

Location

University of Florida Health Science Center

Gainesville, Florida, 32610-0296, United States

Location

Health First Holmes Regional Medical Center

Melbourne, Florida, 32901, United States

Location

Veterans Affairs Medical Center - Miami

Miami, Florida, 33125, United States

Location

Sylvester Cancer Center, University of Miami

Miami, Florida, 33136, United States

Location

Baptist Hospital of Miami

Miami, Florida, 33176-2197, United States

Location

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Florida Radiation Oncology Group

Orange Park, Florida, 32073, United States

Location

MD Anderson Cancer Center Orlando

Orlando, Florida, 32806, United States

Location

Bay Medical Center

Panama City, Florida, 32401, United States

Location

Gulf Coast Cancer Treatment Center

Panama City, Florida, 32405-4587, United States

Location

Sarasota Radiation and Medical Oncology Center

Sarasota, Florida, 34233, United States

Location

Tallahassee Memorial Healthcare

Tallahassee, Florida, 32308, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

Emory University Hospital - Atlanta

Atlanta, Georgia, 30322, United States

Location

CCOP - Atlanta Regional

Atlanta, Georgia, 30342-1701, United States

Location

Medical Center/John B. Amos Community Cancer Center

Columbus, Georgia, 31902, United States

Location

Regional Radiation Oncology Center at Rome

Rome, Georgia, 30165, United States

Location

MBCCOP - Hawaii

Honolulu, Hawaii, 96813, United States

Location

Northwest Community Hospital

Arlington Heights, Illinois, 60005, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

CCOP - Central Illinois

Decatur, Illinois, 62526, United States

Location

Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Lutheran General Cancer Care Center

Park Ridge, Illinois, 60068, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States

Location

St. John's Medical Center

Anderson, Indiana, 46016, United States

Location

Bloomington Hospital

Bloomington, Indiana, 47402, United States

Location

Veterans Affairs Medical Center - Indianapolis (Roudebush)

Indianapolis, Indiana, 46202, United States

Location

Clarian Health Partners Inc.

Indianapolis, Indiana, 46206-1367, United States

Location

Community Hospitals of Indianapolis - Regional Cancer Center

Indianapolis, Indiana, 46219, United States

Location

Ball Memorial Hospital

Muncie, Indiana, 47303-3499, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

Wendt Regional Cancer Center of Finley Hospital

Dubuque, Iowa, 52001, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

Albert B. Chandler Medical Center, University of Kentucky

Lexington, Kentucky, 40536-0084, United States

Location

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Louisville Radiation Oncology

Louisville, Kentucky, 40215, United States

Location

Merle M. Mahr Cancer Center

Madisonville, Kentucky, 42431, United States

Location

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809, United States

Location

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

CCOP - Ochsner

New Orleans, Louisiana, 70121, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

Anne Arundel Oncology Center

Annapolis, Maryland, 21401, United States

Location

Greater Baltimore Medical Center and Cancer Center

Baltimore, Maryland, 21204, United States

Location

Harbor Hospital Center

Baltimore, Maryland, 21225, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21225, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Peninsula Regional Medical Center

Salisbury, Maryland, 21801, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Cape Cod Hospital

Hyannis, Massachusetts, 02601, United States

Location

Veterans Affairs Medical Center - Boston (Jamaica Plain)

Jamaica Plain, Massachusetts, 02130, United States

Location

CCOP - Ann Arbor Regional

Ann Arbor, Michigan, 48106, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0752, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

McLaren Regional Cancer Center

Flint, Michigan, 48432, United States

Location

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

Marquette General Hospital

Marquette, Michigan, 49855, United States

Location

MidMichigan Medical Center - Midland

Midland, Michigan, 48670, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

William Beaumont Hospital - Troy

Troy, Michigan, 48098, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Ellis Fischel Cancer Center - Columbia

Columbia, Missouri, 65203, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

Cancer Research for the Ozarks

Springfield, Missouri, 65807, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65807, United States

Location

Mallinckrodt Institute of Radiology

St Louis, Missouri, 63108, United States

Location

St. Louis University Health Sciences Center

St Louis, Missouri, 63110-0250, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Methodist Cancer Center - Omaha

Omaha, Nebraska, 68114, United States

Location

Nebraska Health System

Omaha, Nebraska, 68198-7460, United States

Location

CCOP - Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Elliot Regional Cancer Center

Manchester, New Hampshire, 03103, United States

Location

Cooper Cancer Institute

Camden, New Jersey, 08103, United States

Location

Veterans Affairs Medical Center - East Orange

East Orange, New Jersey, 07018-1095, United States

Location

John F. Kennedy Medical Center

Edison, New Jersey, 08818, United States

Location

Trinitas Hospital - Jersey Street Campus

Elizabeth, New Jersey, 07201, United States

Location

Monmouth Medical Center

Long Branch, New Jersey, 07740-6395, United States

Location

South Jersey Regional Cancer Center

Millville, New Jersey, 08332, United States

Location

Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County

Mount Holly, New Jersey, 08060, United States

Location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

Atlantic City Medical Center

Pomona, New Jersey, 08240, United States

Location

Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

Community Medical Center

Toms River, New Jersey, 08755, United States

Location

St. Francis Medical Center

Trenton, New Jersey, 08629, United States

Location

Associated Radiologists, P.A.

Warren Township, New Jersey, 07059, United States

Location

Radiation Oncology Associates of Albuquerque

Albuquerque, New Mexico, 87109, United States

Location

Cancer Center of Albany Medical Center

Albany, New York, 12208, United States

Location

State University of New York Health Science Center at Brooklyn

Brooklyn, New York, 11203, United States

Location

New York Methodist Hospital

Brooklyn, New York, 11215-3609, United States

Location

Finger Lakes Radiation Oncology Center

Clifton Springs, New York, 14432, United States

Location

CCOP - North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

Champlain Valley Physicians Hospital Medical Center

Plattsburgh, New York, 12901, United States

Location

Vassar Brothers Hospital

Poughkeepsie, New York, 12601, United States

Location

University of Rochester Cancer Center

Rochester, New York, 14642, United States

Location

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

Syracuse, New York, 13217, United States

Location

Riverhill Radiation Oncology

Yonkers, New York, 10701, United States

Location

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295, United States

Location

Northeast Medical Center

Concord, North Carolina, 28025, United States

Location

East Carolina University School of Medicine

Greenville, North Carolina, 27858-4354, United States

Location

CCOP - Southeast Cancer Control Consortium

Winston-Salem, North Carolina, 27104-4241, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

Trinity Cancer Care Center

Minot, North Dakota, 58701, United States

Location

Akron General Medical Center

Akron, Ohio, 44302, United States

Location

Akron City Hospital

Akron, Ohio, 44309, United States

Location

Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Barrett Cancer Center, The University Hospital

Cincinnati, Ohio, 45267-0502, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

CCOP - Columbus

Columbus, Ohio, 43206, United States

Location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

CCOP - Dayton

Kettering, Ohio, 45429, United States

Location

CCOP - Toledo Community Hospital Oncology Program

Toledo, Ohio, 43623-3456, United States

Location

St. Anthony Hospital

Oklahoma City, Oklahoma, 73101, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73190, United States

Location

St. John Health System

Tulsa, Oklahoma, 74104, United States

Location

CCOP - Columbia River Program

Portland, Oregon, 97213, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

Location

St. Luke's Hospital Regional Cancer Center

Bethlehem, Pennsylvania, 18015, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Fitzgerald Mercy Hospital

Darby, Pennsylvania, 19023, United States

Location

Delaware County Memorial Hospital

Drexel Hill, Pennsylvania, 19026, United States

Location

Pocono Cancer Center

East Stroudsburg, Pennsylvania, 18301, United States

Location

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Veterans Affairs Medical Center - Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Albert Einstein Cancer Center

Philadelphia, Pennsylvania, 19141, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213-3489, United States

Location

Mercy Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

Location

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

Reading Hospital and Medical Center

Reading, Pennsylvania, 19612-6052, United States

Location

Mercy Hospital Cancer Center - Scranton

Scranton, Pennsylvania, 18501, United States

Location

Wilkes Barre General Hospital

Wilkes-Barre, Pennsylvania, 18764, United States

Location

York Hospital

York, Pennsylvania, 17315, United States

Location

Roger Williams Medical Center/BUSM

Providence, Rhode Island, 02908-4735, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57709, United States

Location

Jackson-Madison County General Hospital

Jackson, Tennessee, 38301, United States

Location

University of Tennessee, Memphis Cancer Center

Memphis, Tennessee, 38103, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Harrington Cancer Center

Amarillo, Texas, 79106, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0209, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Wilford Hall - 59th Medical Wing

Lackland Air Force Base, Texas, 78236-5300, United States

Location

Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, 79410-1894, United States

Location

Bayshore Medical Center

Pasadena, Texas, 77504, United States

Location

University of Utah Health Sciences Center

Salt Lake City, Utah, 84132, United States

Location

Latter Day Saints Hospital

Salt Lake City, Utah, 84143, United States

Location

Dixie Regional Medical Center

St. George, Utah, 84770, United States

Location

Green Mountain Oncology Group

Bennington, Vermont, 05201, United States

Location

Vermont Cancer Center

Burlington, Vermont, 05401-3498, United States

Location

Cancer Center at the University of Virginia

Charlottesville, Virginia, 22908, United States

Location

RMH Regional Cancer Center

Harrisonburg, Virginia, 22801, United States

Location

Naval Medical Center, Portsmouth

Portsmouth, Virginia, 23708-2197, United States

Location

Bon-Secours - St. Mary's Hospital

Richmond, Virginia, 23226, United States

Location

Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98111, United States

Location

Deaconess Medical Center

Spokane, Washington, 99210-0248, United States

Location

Yakima Valley Memorial Hospital

Yakima, Washington, 98902, United States

Location

Schiffler Cancer Center

Wheeling, West Virginia, 26003, United States

Location

St. Vincent Hospital

Green Bay, Wisconsin, 54307-3508, United States

Location

Gundersen Lutheran Medical Foundation

La Crosse, Wisconsin, 54601, United States

Location

Southern Wisconsin Radiotherapy Center

Madison, Wisconsin, 53713, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

Marshfield Clinic

Marshfield, Wisconsin, 54449, United States

Location

Community Memorial Hospital

Menomonee Falls, Wisconsin, 53051, United States

Location

Columbia Hospital

Milwaukee, Wisconsin, 53211, United States

Location

St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Southeastern Wisconsin Regional Cancer Center

Racine, Wisconsin, 53405, United States

Location

Waukesha Memorial Hospital

Waukesha, Wisconsin, 53188, United States

Location

Tom Baker Cancer Center - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada

Location

Newfoundland Cancer Treatment and Research Foundation

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Nova Scotia Cancer Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Northeastern Ontario Regional Cancer Centre, Sudbury

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Cancer Care Ontario-Hamilton Regional Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Kingston Regional Cancer Centre

Kingston, Ontario, K7L 5P9, Canada

Location

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Ottawa Regional Cancer Centre

Ottawa, Ontario, K1H 1C4, Canada

Location

Northwestern Ontario Regional Cancer Centre, Thunder Bay

Thunder Bay, Ontario, P7A 7T1, Canada

Location

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

CHUS-Hopital Fleurimont

Fleurimont, Quebec, J1H 5N4, Canada

Location

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2L-4M1, Canada

Location

McGill University

Montreal, Quebec, H2W 1S6, Canada

Location

Centre Hospitalier Universitaire de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Related Publications (5)

• 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.

  PMID: 19636019 BACKGROUND

• 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.

  BACKGROUND

• 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-daily radiotherapy followed by selective bladder preservation or radical cystectomy and adjuvant chemotherapy. Urology. 2009 Apr;73(4):833-7. doi: 10.1016/j.urology.2008.09.036. Epub 2008 Dec 18.

  PMID: 19100600 RESULT

• 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.

  RESULT

• Mak RH, Hunt D, Shipley WU, Efstathiou JA, Tester WJ, Hagan MP, Kaufman DS, Heney NM, Zietman AL. Long-term outcomes in patients with muscle-invasive bladder cancer after selective bladder-preserving combined-modality therapy: a pooled analysis of Radiation Therapy Oncology Group protocols 8802, 8903, 9506, 9706, 9906, and 0233. J Clin Oncol. 2014 Dec 1;32(34):3801-9. doi: 10.1200/JCO.2014.57.5548. Epub 2014 Nov 3.

  PMID: 25366678 DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Cisplatin; Gemcitabine; Paclitaxel; Radiotherapy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Therapeutics

Study Officials

• Donald S. Kaufman, MD

  Massachusetts General Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: September 30, 2003
• Study Start: September 1, 1999
• Primary Completion: July 1, 2003
• Study Completion: November 1, 2013
• Last Updated: October 20, 2020

Record last verified: 2015-10

Locations

US (210); CA (19)