Radiation Therapy With or Without Carbogen and Niacinamide in Treating Patients With Bladder Cancer
NCT ID: NCT00033436
Last Updated: 2013-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
330 participants
INTERVENTIONAL
2000-10-31
2008-11-30
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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niacinamide
carbogen
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed transitional cell carcinoma of the bladder
* Muscle invasive carcinoma (stage T2 or T3) of any grade OR
* High-grade (G3) superficial bladder carcinoma (T1) OR
* Prostatic invasion (T4a)
* No squamous cell carcinoma or adenocarcinoma of the bladder
* No locally advanced T4b carcinoma
* No distant metastasis or enlarged pelvic lymph nodes on CT staging scan of the pelvis
PATIENT CHARACTERISTICS:
Age:
* Over 18
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin no greater than 2 times normal
Renal:
* Creatinine no greater than 2 times normal
Cardiovascular:
* No ischemic heart disease or peripheral vascular disease requiring diuretics or angiotensin-converting enzyme inhibitors
Pulmonary:
* No concurrent respiratory disease with reduced respiratory drive that would preclude the delivery of 95% oxygen
Other:
* Capable of complying with a closed breathing system delivering carbogen through either a mask or a mouthpiece with nasal clip
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* Not specified
18 Years
ALL
No
Sponsors
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Mount Vernon Cancer Centre at Mount Vernon Hospital
OTHER
Principal Investigators
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Peter J. Hoskin, MD
Role: STUDY_CHAIR
Mount Vernon Cancer Centre at Mount Vernon Hospital
Locations
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Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom
Kent and Canterbury Hospital
Canterbury, England, United Kingdom
Derbyshire Royal Infirmary
Derby, England, United Kingdom
Ipswich Hospital NHS Trust
Ipswich, England, United Kingdom
Cookridge Hospital at Leeds Teaching Hospital NHS Trust
Leeds, England, United Kingdom
Christie Hospital NHS Trust
Manchester, 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
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom
Oldchurch Hospital
Romford, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, United Kingdom
Countries
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References
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Hoskin PJ, Rojas AM, Saunders MI, Bentzen SM, Motohashi KJ; BCON investigators. Carbogen and nicotinamide in locally advanced bladder cancer: early results of a phase-III randomized trial. Radiother Oncol. 2009 Apr;91(1):120-5. doi: 10.1016/j.radonc.2008.10.001. Epub 2008 Nov 5.
Choudhury A, Porta N, Hall E, Song YP, Owen R, MacKay R, West CML, Lewis R, Hussain SA, James ND, Huddart R, Hoskin P; BC2001 and BCON investigators. Hypofractionated radiotherapy in locally advanced bladder cancer: an individual patient data meta-analysis of the BC2001 and BCON trials. Lancet Oncol. 2021 Feb;22(2):246-255. doi: 10.1016/S1470-2045(20)30607-0.
Other Identifiers
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MTVERNHOSP-BCON
Identifier Type: -
Identifier Source: secondary_id
EU-20051
Identifier Type: -
Identifier Source: secondary_id
CDR0000069283
Identifier Type: -
Identifier Source: org_study_id