Radiation Therapy With or Without Carbogen and Niacinamide in Treating Patients With Bladder Cancer
- Conditions
- Bladder Cancer
- Registration Number
- NCT00033436
- Lead Sponsor
- Mount Vernon Cancer Centre at Mount Vernon Hospital
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* Compare the 6-month cystoscopic response in patients with locally advanced transitional cell carcinoma of the bladder treated with radical radiotherapy with or without radiosensitization with carbogen and niacinamide.
* Compare the local failure-free and overall disease-specific survival of patients treated with these regimens.
* Compare the treatment-related morbidity, in particular acute and chronic bowel and bladder symptoms, in patients treated with these regimens.
* Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive radical radiotherapy once daily, 5 days a week, for 4-6.4 weeks. Patients also receive oral niacinamide once daily 1.5-2 hours before initiation of each radiotherapy dose and carbogen through a closed breathing system (face mask with a tight air seal or a mouthpiece with nasal clip) once daily beginning 5 minutes before initiation and continuing until completion of each radiotherapy dose.
* Arm II: Patients receive radiotherapy as in arm I. Quality of life is assessed at baseline; at 4 weeks; at 3, 6, and 12 months; and then annually for 4 years.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 330
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall disease-specific survival Local failure-free survival Cystoscopic response at 6 months after initiation radiotherapy
- Secondary Outcome Measures
Name Time Method Treatment related morbidity (i.e., acute and chronic bowel and bladder symptoms) Quality of life as assessed by FACT-BI scale at baseline, week 4, 3 months, 6 months, 12 months, and yearly thereafter for 5 years
Trial Locations
- Locations (14)
Oldchurch Hospital
🇬🇧Romford, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
🇬🇧Northwood, England, United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital
🇬🇧Brighton, England, United Kingdom
Derbyshire Royal Infirmary
🇬🇧Derby, England, United Kingdom
Ipswich Hospital NHS Trust
🇬🇧Ipswich, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
🇬🇧Sheffield, England, United Kingdom
Clatterbridge Centre for Oncology NHS Trust
🇬🇧Merseyside, England, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital
🇬🇧Newcastle-Upon-Tyne, England, United Kingdom
Bristol Haematology and Oncology Centre
🇬🇧Bristol, England, United Kingdom
Kent and Canterbury Hospital
🇬🇧Canterbury, England, United Kingdom
Cookridge Hospital at Leeds Teaching Hospital NHS Trust
🇬🇧Leeds, England, United Kingdom
Christie Hospital NHS Trust
🇬🇧Manchester, England, United Kingdom
Nottingham City Hospital NHS Trust
🇬🇧Nottingham, England, United Kingdom
Velindre Cancer Center at Velindre Hospital
🇬🇧Cardiff, Wales, United Kingdom