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Sponsored by: |
Mount Vernon Cancer Centre at Mount Vernon Hospital |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00033436 |
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as carbogen and niacinamide may make tumor cells more sensitive to radiation therapy. It is not yet known whether radiation therapy is more effective with or without carbogen and niacinamide in treating patients who have bladder cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without carbogen and niacinamide in treating patients who have locally advanced bladder cancer.
Condition | Intervention | Phase |
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Bladder Cancer |
Drug: carbogen Drug: niacinamide Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Multicenter Randomized Trial of Radical Radiotherapy With Carbogen in the Radical Treatment of Locally Advanced Bladder Cancer |
Estimated Enrollment: | 330 |
Study Start Date: | October 2000 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Patients are followed at 8 and 12 weeks; at 6, 9, and 12 months; and then every 6 months for 4 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 330 patients (165 per treatment arm) 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 transitional cell carcinoma of the bladder
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United Kingdom, England | |
Bristol Haematology and Oncology Centre | |
Bristol, England, United Kingdom, BS2 8ED | |
Cancer Research Centre at Weston Park Hospital | |
Sheffield, England, United Kingdom, S1O 2SJ | |
Christie Hospital NHS Trust | |
Manchester, England, United Kingdom, M20 4BX | |
Ipswich Hospital NHS Trust | |
Ipswich, England, United Kingdom, IP4 5PD | |
Cookridge Hospital at Leeds Teaching Hospital NHS Trust | |
Leeds, England, United Kingdom, LS16 6QB | |
Derbyshire Royal Infirmary | |
Derby, England, United Kingdom, DE1 2QY | |
Clatterbridge Centre for Oncology NHS Trust | |
Merseyside, England, United Kingdom, CH63 4JY | |
Kent and Canterbury Hospital | |
Canterbury, England, United Kingdom, CT2 3NG | |
Mount Vernon Cancer Centre at Mount Vernon Hospital | |
Northwood, England, United Kingdom, HA6 2RN | |
Northern Centre for Cancer Treatment at Newcastle General Hospital | |
Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE | |
Nottingham City Hospital NHS Trust | |
Nottingham, England, United Kingdom, NG5 1PB | |
Oldchurch Hospital | |
Romford, England, United Kingdom, RM7 OBE | |
Sussex Cancer Centre at Royal Sussex County Hospital | |
Brighton, England, United Kingdom, BN2 5BF | |
United Kingdom, Wales | |
Velindre Cancer Center at Velindre Hospital | |
Cardiff, Wales, United Kingdom, CF14 2TL |
Study Chair: | Peter J. Hoskin, MD | Mount Vernon Cancer Centre at Mount Vernon Hospital |
Study ID Numbers: | CDR0000069283, MTVERNHOSP-BCON, EU-20051 |
Study First Received: | April 9, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00033436 |
Health Authority: | United States: Federal Government |
stage I bladder cancer stage II bladder cancer stage III bladder cancer transitional cell carcinoma of the bladder |
Cystocele Niacinamide Carbogen Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Neoplasms Carcinoma, Transitional Cell |
Urologic Neoplasms Transitional cell carcinoma Carcinoma Urologic Diseases Urinary tract neoplasm Bladder neoplasm |
Neoplasms Vitamin B Complex Neoplasms by Site Radiation-Sensitizing Agents Growth Substances |
Vitamins Physiological Effects of Drugs Micronutrients Pharmacologic Actions |