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Sponsored by: |
University Hospital Birmingham |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00024349 |
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: Randomized phase 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.
Condition | Intervention | Phase |
Bladder Cancer |
Drug: fluorouracil Drug: mitomycin C Procedure: radiation therapy |
Phase III |
Genetics Home Reference related topics: | bladder cancer |
MedlinePlus related topics: | Bladder Cancer Cancer |
ChemIDplus related topics: | Fluorouracil Mitomycin Mitomycins |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | 2X2 Factorial Randomized Phase III Study Comparing Standard Versus Reduced Volume Radiotherapy With and Without Synchronous Chemotherapy in Muscle Invasive Bladder Cancer |
Estimated Enrollment: | 350 |
Study Start Date: | June 2001 |
OBJECTIVES:
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 two treatment arms.
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.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive bladder cancer (T2-4a, N0, M0)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United Kingdom, England | |||||
Addenbrooke's Hospital | |||||
Cambridge, England, United Kingdom, CB2 2QQ | |||||
Bristol Haematology and Oncology Centre | |||||
Bristol, England, United Kingdom, BS2 8ED | |||||
Cheltenham General Hospital | |||||
Cheltenham, England, United Kingdom, GL53 7AN | |||||
Clatterbridge Centre for Oncology | |||||
Merseyside, England, United Kingdom, CH63 4JY | |||||
Derbyshire Royal Infirmary | |||||
Derby, England, United Kingdom, DE1 2QY | |||||
Essex County Hospital | |||||
Colchester, England, United Kingdom, C03 3NB | |||||
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust | |||||
Birmingham, England, United Kingdom, B15 2TH | |||||
James Cook University Hospital | |||||
Middlesbrough, England, United Kingdom, TS4 3BW | |||||
Maidstone Hospital | |||||
Maidstone, England, United Kingdom, ME16 9QQ | |||||
Northampton General Hospital NHS Trust | |||||
Northampton, England, United Kingdom, NN1 5BD | |||||
Northern Centre for Cancer Treatment at Newcastle General Hospital | |||||
Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE | |||||
Princess Royal Hospital at Hull and East Yorkshire NHS Trust | |||||
Hull, England, United Kingdom, HU8 9HE | |||||
Good Hope Hospital Trust | |||||
West Midlands, England, United Kingdom, B75 7RR | |||||
Royal Bournemouth Hospital NHS Trust | |||||
Bournemouth, England, United Kingdom, BH7 7DW | |||||
Royal Devon and Exeter Hospital | |||||
Exeter, England, United Kingdom, EX2 5DW | |||||
Royal Marsden NHS Foundation Trust - Surrey | |||||
Sutton, England, United Kingdom, SM2 5PT | |||||
Royal Shrewsbury Hospital | |||||
Shrewsbury, England, United Kingdom, SY3 8XQ | |||||
St. Luke's Cancer Centre at Royal Surrey County Hospital | |||||
Guildford, England, United Kingdom, GU2 7XX | |||||
Southend University Hospital NHS Foundation Trust | |||||
Westcliff-On-Sea, England, United Kingdom, SS0 0RY | |||||
Royal United Hospital | |||||
Bath, England, United Kingdom, BA1 3NG | |||||
St. Thomas' Hospital | |||||
London, England, United Kingdom, SE1 9RT | |||||
Sussex Cancer Centre at Royal Sussex County Hospital | |||||
Brighton, England, United Kingdom, BN2 5BF | |||||
Torbay Hospital | |||||
Torquay, England, United Kingdom, TQ2 7AA | |||||
Walsgrave Hospital | |||||
Coventry, England, United Kingdom, CV2 2DX | |||||
Worthing Hospital | |||||
Worthing, England, United Kingdom, BN11 2DH | |||||
Yeovil District Hospital | |||||
Yeovil, England, United Kingdom, BA21 4AT | |||||
United Kingdom, Wales | |||||
Glan Clwyd Hospital | |||||
Rhyl, Wales, United Kingdom, LL18 5UG |
University Hospital Birmingham |
Study Chair: | Nicholas D. James, MD | University Hospital Birmingham |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000068921, CRC-BC2001, EU-20052, ISRCTN68324339 |
First Received: | September 13, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00024349 |
Health Authority: | United States: Federal Government |
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