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| NB: The information displayed below does not replace the protocol. The latest protocol version should always be consulted before making clinical decisions. |
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BOXIT
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BOXIT
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Topic
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Cancer
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Portfolio Eligibility
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UKCRN adopted, non-commercial study
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ISRCTN
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84681538
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EudraCT
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2006-000687-89
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MREC N° |
06/Q0104/57
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UKCRN ID |
2074
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WHO ID
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Research Summary
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1. To determine if the addition of the oral cyclooxygenase-2(COX-2) inhibitor celecoxib to standard therapy is more effective in terms of recurrence-free survival at three years than standard therapy alone towards the treatment of superficial transitional cell carcinoma (TCC) of the bladder at high risk of recurrence
2. To determine if the addition of the oral COX-2 inhibitor celecoxib to standard therapy is more effective in terms of recurrence-free survival at three years than standard therapy alone for the treatment of superficial TCC of the bladder at intermediate risk of recurrence
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Study Type |
Interventional
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Design Type |
Treatment
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Disease(s) |
Bladder (superficial)
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Phase |
III
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Current Status
| Open |
| Closure Date | 01/11/2011 |
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Sample Size
| 900 |
| Accrual to Date |
 24% |
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Geographical Scope
| UK Multi-Centre |
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Lead Country
| Unknown |
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Open to new sites
| Yes, within and outside lead country |
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Main Inclusion Criteria
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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.
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:
- haemoglobin ³10 g/dl;
- neutrophil count ³ 1.5 x 109/l;
- platelets ³ 100 x 109/l;
- WBC ³ 3.0 ´ 109/l or ANC ³ 1.5 ´ 109/l;
- Serum creatinine < 1.5 ´ UNL.
6.Negative pregnancy test for women of child-bearing potential.
7.At least 2 months since prior celecoxib or NSAIDs (other than low dose aspirin (£ 150mg daily).
8.Baseline ECG showing no evidence of established or acute ischaemic heart disease (e.g. left bundle branch block, pathological q waves, ST elevation or ST-segment depression) and normal clinical cardiovascular assessment.
9.Written informed consent and available for long-term follow-up.
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Main Exclusion Criteria
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1.Low risk of recurrence TCC of the bladder (i.e. stage Ta, G1, solitary (<3), <3cm and <3 occurrences in the past 12 months; stage Ta, G2, solitary (<3), <3cm and <2 recurrences in past 12 months).
2.Carcinoma involving the prostatic urethra or upper urinary tract.
3.³T2 TCC or previous history of ³T2.
4.Significant bleeding disorder, such as familial/genetic pre-disposition to clotting disorder e.g. haemophilia and Von Willebrand disease.
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. Crohns 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 1 or more a day for more than 50 consecutive days in a year.
13.Regular use of celecoxib within the previous 8 weeks.
14.Current or long-term use of oral corticosteroids.
15.Known or suspected congestive heart failure (II-IV NYHA defined in appendix 10) and/or coronary heart disease, previous history of myocardial infarction, coronary artery bypass graft, invasive coronary revascularization or angina, uncontrolled arterial hypertension (ie BP >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.
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Chief Investigator(s)
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| Dr Emma Hall | Prof John Kelly |
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Further details, please contact
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Ms Stephanie Burnett
Institute of Cancer Research
Clinical Trials & Statistics Unit (ICR-CTSU)
Section of Clinical Trials
Brookes Lawley Building
15 Cotswold Road
Sutton
SM2 5NG
UNITED KINGDOM
Tel: 020 8722 4261
stephanie.burnett@icr.ac.uk
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Funder(s) |
Cancer Research UK
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Sponsor(s) |
Addenbrooke's Hospital
Institute of Cancer Research
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