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Radiation Therapy With or Without Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Radiation Therapy With or Without Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Radiation Therapy With or Without Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer Clinical research trials and Radiation Therapy With or Without Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Radiation Therapy With or Without Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer. Radiation Therapy With or Without Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Radiation Therapy With or Without Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their Radiation Therapy With or Without Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Radiation Therapy With or Without Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer  Radiation Therapy With or Without Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer
Radiation Therapy With or Without Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer
For Condition: stage 2 bladder cancer,adenocarcinoma of the bladder,stage 3 bladder cancer,transitional cell carcinoma of the bladder,squamous cell carcinoma of the bladder
Status: Recruiting
Sponsor(s): Cancer Research Campaign Clinical Trials Centre ,
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy such as fluorouracil and mitomycin use different ways to stop tumor cells from dividing so they stop growing or die. Fluorouracil and mitomycin may make the tumor cells more sensitive to radiation therapy. It is not yet known if radiation therapy is more effective with or without chemotherapy in treating bladder cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of radiation therapy to all or part of the bladder with or without chemotherapy in treating patients who have stage II or stage III bladder cancer.
Details: OBJECTIVES: - Compare the efficacy of standard volume radiotherapy vs reduced volume radiotherapy with or without synchronous fluorouracil and mitomycin in patients with stage II or III (muscle invasive) bladder cancer. - Compare the toxicity of these regimens in these patients. - Determine whether reducing the amount of bladder treated with the maximum dose of radiotherapy reduces the toxicity of radiotherapy without impacting local control in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, prior neoadjuvant chemotherapy (yes vs no), and intent to enter only 1 of the possible 2 randomizations on study (yes vs no). Patients are randomized to one of four treatment arms. - Arm I: Patients undergo standard radiotherapy once daily 5 days a week for 4 or 6.5 weeks. Patients also receive synchronous chemotherapy comprising mitomycin IV on day 1 and fluorouracil IV continuously over days 1-5 and 16-20 during radiotherapy. - Arm II: Patients undergo reduced volume radiotherapy once daily 5 days a week for 4 or 6.5 weeks. Patients also receive chemotherapy as in arm I. - Arm III: Patients undergo standard radiotherapy as in arm I (without chemotherapy). - Arm IV: Patients undergo reduced volume radiotherapy as in arm II (without chemotherapy). If standard radiotherapy is clearly indicated (e.g., patients with multiple tumors) patients may be randomized to standard radiotherapy with or without chemotherapy (arms I or III above). If chemotherapy is clearly contraindicated, patients are randomized to standard or reduced volume radiotherapy without chemotherapy (arms III or IV above). Quality of life is assessed at baseline, at the end of therapy, at 6 and 12 months post-randomization, and then annually for at least 5 years. Patients are followed at 6, 9, and 12 months post-randomization and then at least annually thereafter. PROJECTED ACCRUAL: A total of 480 patients (120 per treatment arm) will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed invasive bladder cancer (T2-4a, N0, M0) - Adenocarcinoma - Transitional cell carcinoma - Squamous cell carcinoma - Localized muscle invasion by surgery or imaging - Patients with multiple tumors at time of study are ineligible for reduced volume radiotherapy but may be treated with standard volume radiotherapy on study PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - WHO 0-2 Life expectancy: - Not specified Hematopoietic: - WBC greater than 4,000/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic: - Bilirubin less than 1.5 times upper limit of normal (ULN) - ALT or AST less than 1.5 times ULN Renal: - Glomerular filtration rate greater than 25 mL/min Other: - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception - No inflammatory bowel disease - No other prior malignancy within the past 2 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix - No other prior malignancy or uncontrolled systemic disease that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy to the pelvis Surgery: - See Disease Characteristics - No bilateral hip replacements Other: - No concurrent metronidazole during fluorouracil administration
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NicholasJames, Study Chair, Queen Elizabeth Hospital at University of Birmingham
Maidstone Hospital *Recruiting*
Maidstone, England, ME16 9QQ
United Kingdom
Recruiting Sharon Beesley 44-1622-729-000
Royal United Hospital *Recruiting*
Bath, England, BA1 3NG
United Kingdom
Recruiting Hugh Newman 44-1225-824797
Royal Sussex County Hospital *Recruiting*
Brighton, England, BN2 5BF
United Kingdom
Recruiting David Bloomfield 44-1273-696-955 ext. 7686
Walsgrave Hospital *Recruiting*
Coventry, England, CV2 2DX
United Kingdom
Recruiting Jane Worlding 44-2476-535-269
Princess Royal Hospital *Recruiting*
Hull, England, HU8 9HE
United Kingdom
Recruiting Micheal Carr 44-1482-70-11-51
Glan Clywd District General Hospital *Recruiting*
Rhyl, Wales, LL18 5UG
United Kingdom
Recruiting Anthony Nethersell 44-1745-44-5157
Royal Marsden Hospital - Sutton *Recruiting*
Sutton, England, SM2 5PT
United Kingdom
Recruiting Robert Huddart 44-20-8661-3457
Derbyshire Royal Infirmary *Recruiting*
Derby, England, DE1 2QY
United Kingdom
Recruiting Prabir Chakraborti 44-1332-254843
Bristol Haematology and Oncology Centre *Recruiting*
Bristol, England, BS2 8ED
United Kingdom
Recruiting John Graham 44-117-928-2409
Royal Devon and Exeter Hospital *Recruiting*
Exeter, England, EX2 5DW
United Kingdom
Recruiting Denise Sheehan 44-1392-411-611
Northampton General Hospital NHS Trust *Recruiting*
Northampton, England, NN1 5BD
United Kingdom
Recruiting Christine Elwell 44-1604-545-246
Yeovil District Hospital *Recruiting*
Yeovil - Somerset, England, BA21 4AT
United Kingdom
Recruiting Stephen Falk 44-1935-384-553
Worthing Hospital *Recruiting*
Worthing, England, BN11 2DH
United Kingdom
Recruiting Ralph Beard 44-1903-205-111 ext. 5559
Torbay Hospital *Recruiting*
Torquay Devon, England, TQ2 7AA
United Kingdom
Recruiting A. Lydon 44-1803-655052
Royal Bournemouth Hospital *Recruiting*
Bournemouth, England, BH7 7DW
United Kingdom
Recruiting Tamas Hickish 44-1202-704789
Southend NHS Trust Hospital *Recruiting*
Westcliff-On-Sea, England, SS0 0RY
United Kingdom
Recruiting Jan Prejbisz 44-1702-226-149
Cheltenham General Hospital *Recruiting*
Cheltenham, England, GL53 7AN
United Kingdom
Recruiting Peter Jenkins 44-1242-222-222
Clatterbridge Centre for Oncology NHS Trust *Recruiting*
Merseyside, England, CH63 4JY
United Kingdom
Recruiting I. Syndikus 44-151-334-1155
South Tees Hospitals NHS Trust *Recruiting*
Middlesbrough, Cleveland, England, TS4 3BW
United Kingdom
Recruiting Johannes der Voet 44-1642-850-850
Essex County Hospital *Recruiting*
Colchester, England, C03 3NB
United Kingdom
Recruiting B. Sizer 44-1206-747474
Guy's and St. Thomas' Hospitals NHS Trust *Recruiting*
London, England, SE1 9RT
United Kingdom
Recruiting David Landau 44-20-7955-5000
Royal Shrewsbury Hospital *Recruiting*
Shrewsbury, England, SY3 8XO
United Kingdom
Recruiting Narayanan Srihari 44-1743-261-332
Good Hope Hospital Trust *Recruiting*
West Midlands, England, B75 7RR
United Kingdom
Recruiting John Glaholm 44-121-627-2443
Northern Centre for Cancer Treatment at Newcastle General Hospital *Recruiting*
Newcastle upon Tyne, England, NE4 6BE
United Kingdom
Recruiting J.T. Roberts 44-191-219-4245
Royal Surrey County Hospital *Recruiting*
Guildford, England, GU2 5XX
United Kingdom
Recruiting Robert Laing 01483-406825
Addenbrooke's NHS Trust *Recruiting*
Cambridge, England, CB2 2QQ
United Kingdom
Recruiting Helen Patterson 44-1223-216-525
Queen Elizabeth Hospital at University of Birmingham *Recruiting*
Birmingham, England, B15 2TT
United Kingdom
Recruiting Nicholas James 44-121-414-4097
Additional Information:
Study ID Numbers: CDR0000068921; EU-20052,CRC-BC2001
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00024349
Other Stage 3 Bladder Cancer Studies:
1. Radiation Therapy With or Without Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer
Related Studies:
Other stage 3 bladder cancer Clinical Trials
Other England Clinical Trials
Other Coventry Clinical Trials
Radiation Therapy With or Without Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer
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