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Combination Chemotherapy and Radiation Therapy With or Without Surgery In Treating Patients With Stage II or Stage III Bladder Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Combination Chemotherapy and Radiation Therapy With or Without Surgery In Treating Patients With Stage II or Stage III Bladder Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Combination Chemotherapy and Radiation Therapy With or Without Surgery In Treating Patients With Stage II or Stage III Bladder Cancer Clinical research trials and Combination Chemotherapy and Radiation Therapy With or Without Surgery In Treating Patients With Stage II or Stage III Bladder Cancer medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Combination Chemotherapy and Radiation Therapy With or Without Surgery In Treating Patients With Stage II or Stage III Bladder Cancer. Combination Chemotherapy and Radiation Therapy With or Without Surgery In Treating Patients With Stage II or Stage III Bladder Cancer Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Combination Chemotherapy and Radiation Therapy With or Without Surgery In Treating Patients With Stage II or Stage III Bladder Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their Combination Chemotherapy and Radiation Therapy With or Without Surgery In Treating Patients With Stage II or Stage III Bladder Cancer condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy and Radiation Therapy With or Without Surgery In Treating Patients With Stage II or Stage III Bladder Cancer  Combination Chemotherapy and Radiation Therapy With or Without Surgery In Treating Patients With Stage II or Stage III Bladder Cancer
Combination Chemotherapy and Radiation Therapy With or Without Surgery In Treating Patients With Stage II or Stage III Bladder Cancer
For Condition: stage 3 bladder cancer,stage 2 bladder cancer
Status: Recruiting
Sponsor(s): Radiation Therapy Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of combination chemotherapy plus radiation therapy with or without surgery is more effective in treating bladder cancer. PURPOSE: Randomizedphase II trial to compare the effectiveness of two combination chemotherapy regimens and radiation therapy with or without radical cystectomy in treating patients who have stage II or stage III bladder cancer.
Details: OBJECTIVES: - Compare the safety and tolerability of induction paclitaxel, cisplatin, and radiotherapy vs fluorouracil, cisplatin, and radiotherapy followed by consolidation chemoradiotherapy or radical cystectomy and adjuvant gemcitabine, paclitaxel, and cisplatin in patients with operable stage II or III bladder cancer. - Compare the efficacy of these regimens, in terms of complete response, in patients who have undergone prior transurethral resection (TUR). - Compare the efficacy of these regimens after TUR, in terms of preserving the native tumor-free bladder 5 years after therapy in these patients. - Compare the function of the preserved bladder in patients treated with these regimens after TUR. - Determine the value of tumor histopathologic, molecular genetic, and DNA content parameters as possible prognostic factors for initial tumor response and recurrence-free survival in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to T stage (T2 vs T3/T4 ). Patients are randomized to one of two treatment arms. - Arm I: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and cisplatin IV over 1 hour on days 1-3, 8-10, and 15-17. Patients also receive pelvic radiotherapy twice daily on days 1-5, 8-12, and 15-17. - Arm II: Patients receive fluorouracil IV over 24 hours on days 1-3, and 15-17 and cisplatin IV over 1 hour on days 1-3, 8-10, and 15 and 16. Patients also receive pelvic radiotherapy as in arm I. Patients in both arms who achieve complete response after induction therapy proceed to consolidation therapy on week 8. Patients with operable pT1 or worse tumor response proceed to radical cystectomy on week 9. - Arm I: Patients receive paclitaxel IV over 1 hour on days 1 and 8 and cisplatin IV over 1 hour on days 1, 2, 8, and 9. Patients also receive pelvic radiotherapy twice daily for 8 days. - Arm II: Patients receive 5-FU IV over 24 hours on days 1-3 and 8-10 and cisplatin as in arm I. Patients also receive radiotherapy as in arm I. - Adjuvant chemotherapy (weeks 21-33 or 17-29): Beginning 12 weeks after consolidation therapy or 8 weeks after radical cystectomy, patients receive gemcitabine IV over 30-60 minutes, paclitaxel IV over 1 hour, and cisplatin IV over 1 hour on days 1 and 8. Treatment repeats every 3 weeks for 4 courses. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 96 patients (48 per treatment arm) will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed operable primary muscle invasive bladder cancer - T2-T4a, NX or N0, M0 (stage II or III) - Must have an adequate functioning bladder - Must have undergone a prior transurethral resection of the bladder tumor within the past 6 weeks - No evidence of tumor-related hydronephrosis - No evidence of distant metastases or histologically or cytologically confirmed lymph node metastases - Patients with involvement of the prostatic urethra with transitional cell cancer that was visibly completely resected are allowed - No evidence of stromal invasion of the prostate PATIENT CHARACTERISTICS: Age - Not specified Performance status - Zubrod 0-1 Life expectancy - Not specified Hematopoietic - Hemoglobin at least 10 g/dL - WBC 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 NOTE: If the creatinine clearance is greater than 60 mL/min, creatinine of no greater than 1.8 mg/dL is allowed at the discretion of the study chair Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other malignancy within the past 5 years except nonmelanoma skin cancer, stage T1a prostate cancer, or carcinoma in situ of the cervix - Must be able to tolerate systemic chemotherapy with pelvic radiotherapy and radical cystectomy 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 drugs that have potential nephrotoxicity or ototoxicity (e.g., aminoglycosides)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertUzzo, , Fox Chase Cancer Center
Dixie Regional Medical Center *Recruiting*
St. George, Utah, 84770
United States
Recruiting Ray Richards 801-688-4175
Foundation for Cancer Research and Education *Recruiting*
Phoenix, Arizona, 85013
United States
Recruiting David Brachman 602-274-4484
Mills-Peninsula Health Services *Recruiting*
Burlingame, California, 94010
United States
Recruiting Contact Person 415-696-5400
LDS Hospital *Recruiting*
Salt Lake City, Utah, 84143
United States
Recruiting William Sause 801-408-1146
Medical College of Ohio Cancer Institute *Recruiting*
Toledo, Ohio, 43614
United States
Recruiting Contact Person 419-383-4000
South Jersey Regional Cancer Center *Recruiting*
Millville, New Jersey, 08332
United States
Recruiting Joseph Fanelle 856-293-2910
CCOP - Kansas City *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Jorge Paradelo 816-823-0555
Piedmont Hematology Oncology Associates *Recruiting*
Winston Salem, North Carolina, 27103
United States
Recruiting Contact Person 336-277-8800
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital *Recruiting*
Mount Holly, New Jersey, 08060
United States
Recruiting Lemuel Ariaratnam 609-261-7074
Cottonwood Hospital Medical Center *Recruiting*
Murray, Utah, 84107
United States
Recruiting Contact Person 801-341-5300
Wendt Regional Cancer Center of Finley Hospital *Recruiting*
Dubuque, Iowa, 52001
United States
Recruiting Thomas Lally 319-589-2468
Ellis Fischel Cancer Center at University of Missouri - Columbia *Recruiting*
Columbia, Missouri, 65203
United States
Recruiting Mark Bryer 573-882-2100
Shands Cancer Center at the University of Florida Health Science Center *Recruiting*
Gainesville, Florida, 32610-0385
United States
Recruiting William Mendenhall 352-265-0287
CCOP - Mount Sinai Medical Center *Recruiting*
Miami, Florida, 33140
United States
Recruiting Michael Samuels 305-674-2625
Toledo Clinic *Recruiting*
Oregon, Ohio, 43616
United States
Recruiting Contact Person 419-691-4235
McKay-Dee Hospital Center *Recruiting*
Ogden, Utah, 84403
United States
Recruiting Contact Person 801-627-2800
Ella Milbank Foshay Cancer Center at Jupiter Medical Center *Recruiting*
Jupiter, Florida, 33458
United States
Recruiting Contact Person 561-747-2234
Rapid City Regional Hospital *Recruiting*
Rapid City, South Dakota, 57709
United States
Recruiting Daniel Petereit 605-719-2360
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111
United States
Recruiting Benjamin Movsas 215-728-3631
Sutter Health Western Division Cancer Research Group *Recruiting*
Greenbrae, California, 94904
United States
Recruiting David Irwin 415-925-7916
West Michigan Cancer Center *Recruiting*
Kalamazoo, Michigan, 49007
United States
Recruiting Contact Person 616-373-7488
Firelands Regional Medical Center *Recruiting*
Sandusky, Ohio, 44870
United States
Recruiting Contact Person 419-626-7480
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19107-5541
United States
Recruiting Walter Curran 215-955-6700
Marin General Hospital Cancer Institute *Recruiting*
Greenbrae, California, 94904
United States
Recruiting Contact Person 415-925-7822
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
Forsyth Regional Cancer Center *Recruiting*
Winston Salem, North Carolina, 27103
United States
Recruiting Contact Person 336-718-2005
Memorial Hospital Cancer Center *Recruiting*
Colorado Springs, Colorado, 80909
United States
Recruiting Mark Hazuka 719-365-5800
Baptist Hospital of Miami *Recruiting*
Miami, Florida, 33256-2110
United States
Recruiting Andre Abitbol 305-596-6566
CCOP - Toledo Community Hospital *Recruiting*
Toledo, Ohio, 43623-3456
United States
Recruiting Paul Schaefer 419-843-6147
Fulton County Health Center *Recruiting*
Wauseon, Ohio, 43567
United States
Recruiting Contact Person 419-335-2015
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital *Recruiting*
Ft. Lauderdale, Florida, 33308
United States
Recruiting Contact Person 954-776-3126
St. Luke's Hospital Cancer Center *Recruiting*
Bethlehem, Pennsylvania, 18015
United States
Recruiting Nimisha Deb 610-954-4300
Methodist Medical Center of Illinois *Recruiting*
Peoria, Illinois, 61636
United States
Recruiting Revathi Swaminathan 309-672-5700
Veterans Affairs Medical Center - East Orange *Recruiting*
East Orange, New Jersey, 07019
United States
Recruiting Basil Kasimis 973-676-1000 ext. 1544
Western Pennsylvania Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15224
United States
Recruiting Judith Figura 412-578-1923
Lima Memorial Hospital *Recruiting*
Lima, Ohio, 45804
United States
Recruiting Contact Person 419-228-3335
Utah Valley Regional Medical Center - Provo *Recruiting*
Provo, Utah, 84604
United States
Recruiting Tarlton Blair 801-373-7850 ext. 2480
Fremont Memorial Hospital *Recruiting*
Fremont, Ohio, 43420
United States
Recruiting Contact Person 419-334-6639
Additional Information:
Study ID Numbers: CDR0000258303; RTOG-0233
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00055601
Other Stage 2 Bladder Cancer Studies:
1. Combination Chemotherapy and Radiation Therapy With or Without Surgery In Treating Patients With Stage II or Stage III Bladder Cancer
2. Comparison of Immediate and Delayed Adjuvant Chemotherapy in Treating Patients Who Have Undergone a Radical Cystectomy for Stage III or Stage IV Transitional Cell Carcinoma of the Bladder Urothelium
3. Radiation Therapy With or Without Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer
4. Surgery Plus Combination Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Urinary Tract
5. Combination Chemotherapy in Treating Patients With Bladder Cancer
Related Studies:
Other stage 2 bladder cancer Clinical Trials
Other Iowa Clinical Trials
Other Dubuque Clinical Trials
Combination Chemotherapy and Radiation Therapy With or Without Surgery In Treating Patients With Stage II or Stage III Bladder Cancer
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