Bladder Cancer Clinical Trial
Official title:
A Multicenter Randomized Trial of Radical Radiotherapy With Carbogen in the Radical Treatment of Locally Advanced Bladder Cancer
Verified date | December 2002 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 330 |
Est. completion date | November 2008 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - 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 |
Allocation: Randomized, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | 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 | Velindre Cancer Center at Velindre Hospital | Cardiff | Wales |
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 |
Lead Sponsor | Collaborator |
---|---|
Mount Vernon Cancer Centre at Mount Vernon Hospital |
United Kingdom,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cystoscopic response at 6 months after initiation radiotherapy | No | ||
Primary | Local failure-free survival | No | ||
Primary | Overall disease-specific survival | No | ||
Secondary | Treatment related morbidity (i.e., acute and chronic bowel and bladder symptoms) | No | ||
Secondary | 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 | No |
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