ISRCTN84681538已完成3 期
A randomised phase III placebo-controlled trial evaluating the addition of celecoxib to standard treatment of transitional cell carcinoma of the bladder
The Institute of Cancer Research (UK)0 个研究点目标入组 472 人开始时间: 2006年2月23日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 472
研究概览
简要总结
2014 results in: https://www.ncbi.nlm.nih.gov/pubmed/24612661 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30279015 (added 14/08/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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.
- •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 < 1.5 x 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.
- •Previous inclusion criteria:
- •1. Primary or recurrent superficial TCC of the bladder of intermediate or high risk of recurrence.
- •High-risk patients are defined as:
- •a. Any Grade 3
- •b. Tis (i.e. carcinoma in situ)
- •c. T1 Grade 2 and multiple tumours (=3)
- •d. T1 Grade 2 and highly recurrent (=3 per year)
- •e. T1 Grade 2 and diameter =3 cm
- •Intermediate-risk patients are defined as:
- •a. T1 Grade 2 (other than high risk)
- •b. Ta Grade 2 and multiple (=3)
- •c. Ta Grade 2 and diameter =3 cm
- •d. Ta Grade 2 and =2 recurrences in past year
- •e. Ta Grade 1 and multiple (=3)
- •f. Ta Grade 1 and diameter =3 cm
- •g. Ta Grade 1 and highly recurrent (=3 in past year)
- •h. T1 Grade 1
- •2. Age >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 f
排除标准
- •Current exclusion criteria as of 27/09/2011:
- •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. =T2 TCC or previous history of =T2.
- •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. 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 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.
- •Previous exclusion criteria:
- •1. Low risk of recurrence TCC of the bladder (i.e. stage Ta, G1, solitary [<3], <3 cm and <3 recurrences in past 12 months; stage Ta, G2, solitary [<3], <3 cm and <3 recurrences in past 12 months)
- •2. Carcinoma involving the prostatic urethra or upper urinary tract
- •3. T2 or >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)
研究者
相似试验
已完成
不适用
Phase III randomised, double-blind, placebo-controlled trial of Gefitinib (Iressa®) versus placebo in Oesophageal Cancer progressing after chemotherapyCancerOesophageal cancerISRCTN29580179niversity of Oxford (UK)450
已完成
3 期
Safety and efficacy trial of two doses of lurasidone in acutely psychotic subjects with schizophrenia (PEARL 3)Mental and Behavioural DisordersSchizophreniaISRCTN64695913Dainippon Sumitomo Pharma America Inc. (USA)480
已完成
3 期
A randomised, placebo-control phase III study to assess the safety and efficacy of the MPT64 patch test in the diagnosis of active tuberculosis (TB)Active pulmonary tuberculosis.Infections and InfestationsTuberculosisISRCTN49676555Sequella Inc (USA)512
已完成
不适用
SUBpectoral Local anaesthetic Infusion following MastEctomy - version 1 (SUBLIME)Breast CancerCancerISRCTN46621916Royal Cornwall Hospitals NHS Trust (UK)160
已完成
4 期
What are the indications for prescribing antidepressants that will lead to a clinical benefit?ISRCTN84544741niversity College London (UK)655