Transitional Cell Carcinoma (TCC) of the bladder Cancer
Conditions
Interventions
Celecoxib: 400 mg daily (200 mg twice a day [bid]) for 2 years or placebo.
Added 27/11/2025:
Additional Data Linkage Information:
Participants from this trial will also be included in the INTERACT pr
Sponsors
The Institute of Cancer Research (UK)
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 27/09/2011: 1. Primary or recurrent non-muscle invasive TCC of the bladder of high or intermediate risk of recurrence: High risk cases are those patients who are scheduled to receive BCG. Intermediate risk includes all other Ta, T1 cases excluding low risk disease. Full definitions of the risk groups based on EAU guidelines are given in appendix 4: 2. Age =18 years. 3. WHO performance status 0, 1 or 2. 4. No evidence of upper tract TCC on imaging studies within the past 36 months or before randomisation. 5. Pre-treatment haematology and biochemistry values within acceptable limits: 5.1 haemoglobin =10 g/dl; 5.2 neutrophil count = 1.5 x 109/l; 5.3 platelets = 100 x 109/l; 5.4 WBC = 3.0 x 109/l or ANC = 1.5 x 109/l; 5.5 Serum creatinine 18 3. World Health Organisation (WHO) performance status 0, 1 or 2 4. Normal kidneys and urethras on imaging study within the past 36 months or before randomisation 5. Pre-treatment haematology and biochemistry values within acceptable limits: a. Haemoglobin =10 g/dl b. Neutrophil count =1.5 x 10^9/l c. Platelets =100 x 10^9/l d. White blood cell count (WBC) =3.0 x 10^9/l or absolute neutrophil count (ANC) =1.5 x 10^9/l e. Serum creatinine <1.5 x upper normal limit (UNL) 6. Negative pregnancy test for women of childbearing potential 7. At least two months since prior taking of celecoxib or other non-steroidal anti-inflammatory drugs (NSAIDs) other than low dose aspirin (150 mg daily) 8. Normal baseline electrocardiogram (ECG) and normal clinical cardiovascular assessment 9. Written informed consent and availability for long-term follow-up
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 27/09/2011: 1. Low risk of recurrence TCC of the bladder (i.e. stage Ta, G1, solitary (160/100mmHg). 16. Patients with diabetes controlled by diet and oral medication are eligible for the study; however patients treated with insulin will be excluded. 17. Past history of stroke/TIA, symptomatic peripheral vascular disease, or documented abdominal aortic aneurysm. 18. Other malignancy within the past 2 years, except: non-melanomatous skin cancer cured by excision, adequately treated carcinoma in situ of the cervix, DCIS/LCIS of the breast or prostate cancer in patients who have a life expectancy of over 5 years upon trial entry. 19. Concurrent chemotherapy other than intravesical MMC. 20. Psychiatric or addictive disorders which could preclude obtaining informed consent. Previous exclusion criteria: 1. Low risk of recurrence TCC of the bladder (i.e. stage Ta, G1, solitary [T2 TCC 4. Significant bleeding disorder 5. Chronic or acute renal disorder 6. Oesophageal gastric, pyloric channel, or duodenal ulceration diagnosed or treated within the past 30 days 7. Active or previous peptic ulceration or gastrointestinal bleeding in the last year 8. Inflammatory bowel disease (e.g. Crohn?s disease or ulcerative colitis) 9. Pancreatitis 10. Pregnant or lactating women or women of childbearing potential unwilling or unable to use adequate non-hormonal contraception 11. Hypersensitivity or adverse reactions to sulfonamides, COX-2 inhibitors, salicylates, or other NSAIDs 12. On current or planned chronic NSAIDs therapy (except low-dose aspirin =150 mg once daily). Chronic use of NSAIDs is defined as a frequency of one or more a day, for more than a total of 50 days per year. 13. Regular use of low-dose celecoxib
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence-free survival of TCC of the bladder at 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Recurrence rate (overall and at 3 months) 2. Progression to invasive disease (high-risk patients) 3. Safety and tolerability of celecoxib 4. Disease-free survival 5. Overall survival 6. Quality of life 7. Cost effectiveness 8. Reduction in recurrence within the first 2 years compared with that observed beyond 2 years | — |
Countries
England, United Kingdom
Outcome results
None listed