Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer
Sponsor
Radiation Therapy Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00003930
Collaborator
National Cancer Institute (NCI) (NIH)
84
229
1
170
0.4
0
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
84 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date
:
Sep 1, 1999
Actual Primary Completion Date
:
Jul 1, 2003
Actual Study Completion Date
:
Nov 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
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. [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
- 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.]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham | Alabama | United States | 35294-3300 |
| 2 | Huntsville Hospital System | Huntsville | Alabama | United States | 35801-4470 |
| 3 | Comprehensive Cancer Institute of Huntsville | Huntsville | Alabama | United States | 35801 |
| 4 | MBCCOP - Gulf Coast | Mobile | Alabama | United States | 36688 |
| 5 | Alabama Oncology, LLC | Montgomery | Alabama | United States | 36106-2801 |
| 6 | Radiation Oncology Associates of West Alabama | Tuscaloosa | Alabama | United States | 35401 |
| 7 | Foundation for Cancer Research and Education | Phoenix | Arizona | United States | 85013 |
| 8 | Mount Diablo Medical Center | Concord | California | United States | 94524-4110 |
| 9 | Cancer Center and Beckman Research Institute, City of Hope | Duarte | California | United States | 91010-3000 |
| 10 | California Cancer Center | Fresno | California | United States | 93720 |
| 11 | Saint Agnes Cancer Center | Fresno | California | United States | 93720 |
| 12 | Sutter Health West Cancer Research Group | Greenbrae | California | United States | 94904 |
| 13 | Loma Linda University Medical Center | Loma Linda | California | United States | 92354 |
| 14 | Veterans Affairs Medical Center - Long Beach | Long Beach | California | United States | 90822 |
| 15 | USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California | United States | 90033-0804 |
| 16 | Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California | United States | 90095-1781 |
| 17 | CCOP - Bay Area Tumor Institute | Oakland | California | United States | 94609-3305 |
| 18 | Huntington Cancer Center | Pasadena | California | United States | 91105 |
| 19 | Cancer Care Center | Pomona | California | United States | 91767 |
| 20 | Radiation Oncology Center - Sacramento | Sacramento | California | United States | 95816 |
| 21 | Radiation Medical Group, Inc. | San Diego | California | United States | 92101-1492 |
| 22 | UCSF Cancer Center and Cancer Research Institute | San Francisco | California | United States | 94143-0128 |
| 23 | O'Connor Hospital | San Jose | California | United States | 95128 |
| 24 | CCOP - Santa Rosa Memorial Hospital | Santa Rosa | California | United States | 95403 |
| 25 | David Grant Medical Center | Travis Air Force Base | California | United States | 94535 |
| 26 | Memorial Hospital Cancer Center | Colorado Springs | Colorado | United States | 80909 |
| 27 | University of Colorado Cancer Center | Denver | Colorado | United States | 80010 |
| 28 | Saint Mary's Hospital and Medical Center | Grand Junction | Colorado | United States | 81502 |
| 29 | CCOP - Christiana Care Health Services | Wilmington | Delaware | United States | 19899 |
| 30 | University of Florida Health Science Center | Gainesville | Florida | United States | 32610-0296 |
| 31 | Health First Holmes Regional Medical Center | Melbourne | Florida | United States | 32901 |
| 32 | CCOP - Mount Sinai Medical Center | Miami Beach | Florida | United States | 33140 |
| 33 | Veterans Affairs Medical Center - Miami | Miami | Florida | United States | 33125 |
| 34 | Sylvester Cancer Center, University of Miami | Miami | Florida | United States | 33136 |
| 35 | Baptist Hospital of Miami | Miami | Florida | United States | 33176-2197 |
| 36 | Florida Radiation Oncology Group | Orange Park | Florida | United States | 32073 |
| 37 | MD Anderson Cancer Center Orlando | Orlando | Florida | United States | 32806 |
| 38 | Bay Medical Center | Panama City | Florida | United States | 32401 |
| 39 | Gulf Coast Cancer Treatment Center | Panama City | Florida | United States | 32405-4587 |
| 40 | Sarasota Radiation and Medical Oncology Center | Sarasota | Florida | United States | 34233 |
| 41 | Tallahassee Memorial Healthcare | Tallahassee | Florida | United States | 32308 |
| 42 | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | United States | 33612-9497 |
| 43 | Emory University Hospital - Atlanta | Atlanta | Georgia | United States | 30322 |
| 44 | CCOP - Atlanta Regional | Atlanta | Georgia | United States | 30342-1701 |
| 45 | Medical Center/John B. Amos Community Cancer Center | Columbus | Georgia | United States | 31902 |
| 46 | Regional Radiation Oncology Center at Rome | Rome | Georgia | United States | 30165 |
| 47 | MBCCOP - Hawaii | Honolulu | Hawaii | United States | 96813 |
| 48 | Northwest Community Hospital | Arlington Heights | Illinois | United States | 60005 |
| 49 | Northwestern Memorial Hospital | Chicago | Illinois | United States | 60611 |
| 50 | CCOP - Central Illinois | Decatur | Illinois | United States | 62526 |
| 51 | Ingalls Memorial Hospital | Harvey | Illinois | United States | 60426 |
| 52 | Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
| 53 | Lutheran General Cancer Care Center | Park Ridge | Illinois | United States | 60068 |
| 54 | Methodist Medical Center of Illinois | Peoria | Illinois | United States | 61636 |
| 55 | St. John's Medical Center | Anderson | Indiana | United States | 46016 |
| 56 | Bloomington Hospital | Bloomington | Indiana | United States | 47402 |
| 57 | Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis | Indiana | United States | 46202 |
| 58 | Clarian Health Partners Inc. | Indianapolis | Indiana | United States | 46206-1367 |
| 59 | Community Hospitals of Indianapolis - Regional Cancer Center | Indianapolis | Indiana | United States | 46219 |
| 60 | Ball Memorial Hospital | Muncie | Indiana | United States | 47303-3499 |
| 61 | CCOP - Northern Indiana CR Consortium | South Bend | Indiana | United States | 46601 |
| 62 | Wendt Regional Cancer Center of Finley Hospital | Dubuque | Iowa | United States | 52001 |
| 63 | Central Baptist Hospital | Lexington | Kentucky | United States | 40503 |
| 64 | Albert B. Chandler Medical Center, University of Kentucky | Lexington | Kentucky | United States | 40536-0084 |
| 65 | James Graham Brown Cancer Center | Louisville | Kentucky | United States | 40202 |
| 66 | Louisville Radiation Oncology | Louisville | Kentucky | United States | 40215 |
| 67 | Merle M. Mahr Cancer Center | Madisonville | Kentucky | United States | 42431 |
| 68 | Mary Bird Perkins Cancer Center | Baton Rouge | Louisiana | United States | 70809 |
| 69 | MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana | United States | 70112 |
| 70 | Tulane University School of Medicine | New Orleans | Louisiana | United States | 70112 |
| 71 | CCOP - Ochsner | New Orleans | Louisiana | United States | 70121 |
| 72 | Maine Medical Center | Portland | Maine | United States | 04102 |
| 73 | Anne Arundel Oncology Center | Annapolis | Maryland | United States | 21401 |
| 74 | Greater Baltimore Medical Center and Cancer Center | Baltimore | Maryland | United States | 21204 |
| 75 | Harbor Hospital Center | Baltimore | Maryland | United States | 21225 |
| 76 | Sinai Hospital of Baltimore | Baltimore | Maryland | United States | 21225 |
| 77 | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | United States | 21231-2410 |
| 78 | Peninsula Regional Medical Center | Salisbury | Maryland | United States | 21801 |
| 79 | Massachusetts General Hospital Cancer Center | Boston | Massachusetts | United States | 02114 |
| 80 | Cape Cod Hospital | Hyannis | Massachusetts | United States | 02601 |
| 81 | Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain | Massachusetts | United States | 02130 |
| 82 | CCOP - Ann Arbor Regional | Ann Arbor | Michigan | United States | 48106 |
| 83 | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | United States | 48109-0752 |
| 84 | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | United States | 48201-1379 |
| 85 | Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
| 86 | McLaren Regional Cancer Center | Flint | Michigan | United States | 48432 |
| 87 | Hurley Medical Center | Flint | Michigan | United States | 48503 |
| 88 | CCOP - Kalamazoo | Kalamazoo | Michigan | United States | 49007-3731 |
| 89 | Marquette General Hospital | Marquette | Michigan | United States | 49855 |
| 90 | MidMichigan Medical Center - Midland | Midland | Michigan | United States | 48670 |
| 91 | William Beaumont Hospital | Royal Oak | Michigan | United States | 48073 |
| 92 | William Beaumont Hospital - Troy | Troy | Michigan | United States | 48098 |
| 93 | Mayo Clinic Cancer Center | Rochester | Minnesota | United States | 55905 |
| 94 | CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | United States | 55416 |
| 95 | Ellis Fischel Cancer Center - Columbia | Columbia | Missouri | United States | 65203 |
| 96 | CCOP - Kansas City | Kansas City | Missouri | United States | 64131 |
| 97 | Mallinckrodt Institute of Radiology | Saint Louis | Missouri | United States | 63108 |
| 98 | St. Louis University Health Sciences Center | Saint Louis | Missouri | United States | 63110-0250 |
| 99 | Cancer Research for the Ozarks | Springfield | Missouri | United States | 65807 |
| 100 | CCOP - Cancer Research for the Ozarks | Springfield | Missouri | United States | 65807 |
| 101 | CCOP - Montana Cancer Consortium | Billings | Montana | United States | 59101 |
| 102 | Methodist Cancer Center - Omaha | Omaha | Nebraska | United States | 68114 |
| 103 | Nebraska Health System | Omaha | Nebraska | United States | 68198-7460 |
| 104 | CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada | United States | 89106 |
| 105 | Norris Cotton Cancer Center | Lebanon | New Hampshire | United States | 03756-0002 |
| 106 | Elliot Regional Cancer Center | Manchester | New Hampshire | United States | 03103 |
| 107 | Cooper Cancer Institute | Camden | New Jersey | United States | 08103 |
| 108 | Veterans Affairs Medical Center - East Orange | East Orange | New Jersey | United States | 07018-1095 |
| 109 | John F. Kennedy Medical Center | Edison | New Jersey | United States | 08818 |
| 110 | Trinitas Hospital - Jersey Street Campus | Elizabeth | New Jersey | United States | 07201 |
| 111 | Monmouth Medical Center | Long Branch | New Jersey | United States | 07740-6395 |
| 112 | South Jersey Regional Cancer Center | Millville | New Jersey | United States | 08332 |
| 113 | Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County | Mount Holly | New Jersey | United States | 08060 |
| 114 | Cancer Institute of New Jersey | New Brunswick | New Jersey | United States | 08903 |
| 115 | Newark Beth Israel Medical Center | Newark | New Jersey | United States | 07112 |
| 116 | Atlantic City Medical Center | Pomona | New Jersey | United States | 08240 |
| 117 | Valley Hospital | Ridgewood | New Jersey | United States | 07450 |
| 118 | Community Medical Center | Toms River | New Jersey | United States | 08755 |
| 119 | St. Francis Medical Center | Trenton | New Jersey | United States | 08629 |
| 120 | Associated Radiologists, P.A. | Warren | New Jersey | United States | 07059 |
| 121 | Radiation Oncology Associates of Albuquerque | Albuquerque | New Mexico | United States | 87109 |
| 122 | Cancer Center of Albany Medical Center | Albany | New York | United States | 12208 |
| 123 | State University of New York Health Science Center at Brooklyn | Brooklyn | New York | United States | 11203 |
| 124 | New York Methodist Hospital | Brooklyn | New York | United States | 11215-3609 |
| 125 | Finger Lakes Radiation Oncology Center | Clifton Springs | New York | United States | 14432 |
| 126 | CCOP - North Shore University Hospital | Manhasset | New York | United States | 11030 |
| 127 | Herbert Irving Comprehensive Cancer Center | New York | New York | United States | 10032 |
| 128 | Champlain Valley Physicians Hospital Medical Center | Plattsburgh | New York | United States | 12901 |
| 129 | Vassar Brothers Hospital | Poughkeepsie | New York | United States | 12601 |
| 130 | University of Rochester Cancer Center | Rochester | New York | United States | 14642 |
| 131 | CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse | New York | United States | 13217 |
| 132 | Riverhill Radiation Oncology | Yonkers | New York | United States | 10701 |
| 133 | Lineberger Comprehensive Cancer Center, UNC | Chapel Hill | North Carolina | United States | 27599-7295 |
| 134 | Northeast Medical Center | Concord | North Carolina | United States | 28025 |
| 135 | East Carolina University School of Medicine | Greenville | North Carolina | United States | 27858-4354 |
| 136 | CCOP - Southeast Cancer Control Consortium | Winston-Salem | North Carolina | United States | 27104-4241 |
| 137 | Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina | United States | 27157-1082 |
| 138 | Trinity Cancer Care Center | Minot | North Dakota | United States | 58701 |
| 139 | Akron General Medical Center | Akron | Ohio | United States | 44302 |
| 140 | Akron City Hospital | Akron | Ohio | United States | 44309 |
| 141 | Christ Hospital | Cincinnati | Ohio | United States | 45219 |
| 142 | Barrett Cancer Center, The University Hospital | Cincinnati | Ohio | United States | 45267-0502 |
| 143 | Ireland Cancer Center | Cleveland | Ohio | United States | 44106-5065 |
| 144 | University Hospitals of Cleveland | Cleveland | Ohio | United States | 44106 |
| 145 | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | United States | 44195 |
| 146 | CCOP - Columbus | Columbus | Ohio | United States | 43206 |
| 147 | Arthur G. James Cancer Hospital - Ohio State University | Columbus | Ohio | United States | 43210-1240 |
| 148 | CCOP - Dayton | Kettering | Ohio | United States | 45429 |
| 149 | CCOP - Toledo Community Hospital Oncology Program | Toledo | Ohio | United States | 43623-3456 |
| 150 | St. Anthony Hospital | Oklahoma City | Oklahoma | United States | 73101 |
| 151 | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73190 |
| 152 | St. John Health System | Tulsa | Oklahoma | United States | 74104 |
| 153 | CCOP - Columbia River Program | Portland | Oregon | United States | 97213 |
| 154 | Lehigh Valley Hospital | Allentown | Pennsylvania | United States | 18103 |
| 155 | St. Luke's Hospital Regional Cancer Center | Bethlehem | Pennsylvania | United States | 18015 |
| 156 | Geisinger Medical Center | Danville | Pennsylvania | United States | 17822-2001 |
| 157 | Fitzgerald Mercy Hospital | Darby | Pennsylvania | United States | 19023 |
| 158 | Delaware County Memorial Hospital | Drexel Hill | Pennsylvania | United States | 19026 |
| 159 | Pocono Cancer Center | East Stroudsburg | Pennsylvania | United States | 18301 |
| 160 | Milton S. Hershey Medical Center | Hershey | Pennsylvania | United States | 17033-0850 |
| 161 | University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania | United States | 19104-4283 |
| 162 | Veterans Affairs Medical Center - Philadelphia | Philadelphia | Pennsylvania | United States | 19104 |
| 163 | Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania | United States | 19107-5541 |
| 164 | Fox Chase Cancer Center | Philadelphia | Pennsylvania | United States | 19111 |
| 165 | Albert Einstein Cancer Center | Philadelphia | Pennsylvania | United States | 19141 |
| 166 | University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | United States | 15213-3489 |
| 167 | Mercy Hospital of Pittsburgh | Pittsburgh | Pennsylvania | United States | 15219 |
| 168 | Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | United States | 15224 |
| 169 | Reading Hospital and Medical Center | Reading | Pennsylvania | United States | 19612-6052 |
| 170 | Mercy Hospital Cancer Center - Scranton | Scranton | Pennsylvania | United States | 18501 |
| 171 | Wilkes Barre General Hospital | Wilkes-Barre | Pennsylvania | United States | 18764 |
| 172 | York Hospital | York | Pennsylvania | United States | 17315 |
| 173 | Roger Williams Medical Center/BUSM | Providence | Rhode Island | United States | 02908-4735 |
| 174 | CCOP - Greenville | Greenville | South Carolina | United States | 29615 |
| 175 | CCOP - Upstate Carolina | Spartanburg | South Carolina | United States | 29303 |
| 176 | Rapid City Regional Hospital | Rapid City | South Dakota | United States | 57709 |
| 177 | Jackson-Madison County General Hospital | Jackson | Tennessee | United States | 38301 |
| 178 | University of Tennessee, Memphis Cancer Center | Memphis | Tennessee | United States | 38103 |
| 179 | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | United States | 37232-6838 |
| 180 | Harrington Cancer Center | Amarillo | Texas | United States | 79106 |
| 181 | University of Texas Medical Branch | Galveston | Texas | United States | 77555-0209 |
| 182 | University of Texas - MD Anderson Cancer Center | Houston | Texas | United States | 77030-4009 |
| 183 | Wilford Hall - 59th Medical Wing | Lackland Air Force Base | Texas | United States | 78236-5300 |
| 184 | Joe Arrington Cancer Research and Treatment Center | Lubbock | Texas | United States | 79410-1894 |
| 185 | Bayshore Medical Center | Pasadena | Texas | United States | 77504 |
| 186 | Dixie Regional Medical Center | Saint George | Utah | United States | 84770 |
| 187 | University of Utah Health Sciences Center | Salt Lake City | Utah | United States | 84132 |
| 188 | Latter Day Saints Hospital | Salt Lake City | Utah | United States | 84143 |
| 189 | Green Mountain Oncology Group | Bennington | Vermont | United States | 05201 |
| 190 | Vermont Cancer Center | Burlington | Vermont | United States | 05401-3498 |
| 191 | Cancer Center at the University of Virginia | Charlottesville | Virginia | United States | 22908 |
| 192 | RMH Regional Cancer Center | Harrisonburg | Virginia | United States | 22801 |
| 193 | Naval Medical Center, Portsmouth | Portsmouth | Virginia | United States | 23708-2197 |
| 194 | Bon-Secours - St. Mary's Hospital | Richmond | Virginia | United States | 23226 |
| 195 | Massey Cancer Center | Richmond | Virginia | United States | 23298-0037 |
| 196 | Virginia Mason Medical Center | Seattle | Washington | United States | 98111 |
| 197 | Deaconess Medical Center | Spokane | Washington | United States | 99210-0248 |
| 198 | Yakima Valley Memorial Hospital | Yakima | Washington | United States | 98902 |
| 199 | Schiffler Cancer Center | Wheeling | West Virginia | United States | 26003 |
| 200 | St. Vincent Hospital | Green Bay | Wisconsin | United States | 54307-3508 |
| 201 | Gundersen Lutheran Medical Foundation | La Crosse | Wisconsin | United States | 54601 |
| 202 | Southern Wisconsin Radiotherapy Center | Madison | Wisconsin | United States | 53713 |
| 203 | University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin | United States | 53792-6164 |
| 204 | Marshfield Clinic | Marshfield | Wisconsin | United States | 54449 |
| 205 | Community Memorial Hospital | Menomonee Falls | Wisconsin | United States | 53051 |
| 206 | Columbia Hospital | Milwaukee | Wisconsin | United States | 53211 |
| 207 | St. Luke's Medical Center | Milwaukee | Wisconsin | United States | 53215 |
| 208 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
| 209 | Southeastern Wisconsin Regional Cancer Center | Racine | Wisconsin | United States | 53405 |
| 210 | Waukesha Memorial Hospital | Waukesha | Wisconsin | United States | 53188 |
| 211 | Tom Baker Cancer Center - Calgary | Calgary | Alberta | Canada | T2N 4N2 |
| 212 | Cross Cancer Institute | Edmonton | Alberta | Canada | T6G 1Z2 |
| 213 | Saint John Regional Hospital | Saint John | New Brunswick | Canada | E2L 4L2 |
| 214 | Newfoundland Cancer Treatment and Research Foundation | St. Johns | Newfoundland and Labrador | Canada | A1B 3V6 |
| 215 | Nova Scotia Cancer Centre | Halifax | Nova Scotia | Canada | B3H 1V7 |
| 216 | Cancer Care Ontario-Hamilton Regional Cancer Centre | Hamilton | Ontario | Canada | L8V 5C2 |
| 217 | Kingston Regional Cancer Centre | Kingston | Ontario | Canada | K7L 5P9 |
| 218 | Cancer Care Ontario-London Regional Cancer Centre | London | Ontario | Canada | N6A 4L6 |
| 219 | Ottawa Regional Cancer Centre | Ottawa | Ontario | Canada | K1H 1C4 |
| 220 | Northeastern Ontario Regional Cancer Centre, Sudbury | Sudbury | Ontario | Canada | P3E 5J1 |
| 221 | Northwestern Ontario Regional Cancer Centre, Thunder Bay | Thunder Bay | Ontario | Canada | P7A 7T1 |
| 222 | Toronto Sunnybrook Regional Cancer Centre | Toronto | Ontario | Canada | M4N 3M5 |
| 223 | Princess Margaret Hospital | Toronto | Ontario | Canada | M5G 2M9 |
| 224 | CHUS-Hopital Fleurimont | Fleurimont | Quebec | Canada | J1H 5N4 |
| 225 | Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec | Canada | H2L-4M1 |
| 226 | McGill University | Montreal | Quebec | Canada | H2W 1S6 |
| 227 | Centre Hospitalier Universitaire de Quebec | Quebec City | Quebec | Canada | G1R 2J6 |
| 228 | Allan Blair Cancer Centre | Regina | Saskatchewan | Canada | S4T 7T1 |
| 229 | Saskatoon Cancer Centre | Saskatoon | Saskatchewan | Canada | S7N 4H4 |
Sponsors and Collaborators
- Radiation Therapy Oncology Group
- National Cancer Institute (NCI)
Investigators
- Study Chair: Donald S. Kaufman, MD, Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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
Other Study ID Numbers:
- RTOG-9906
- CDR0000067122
First Posted:
Sep 30, 2003
Last Update Posted:
Oct 20, 2020
Last Verified:
Oct 1, 2015
Keywords provided by Radiation Therapy Oncology Group
Additional relevant MeSH terms: