ISRCTN61126465已完成3 期
Randomised trial of Selective bladder Preservation Against Radical Excision (cystectomy) in muscle invasive T2/T3 transitional cell carcinoma of the bladder: a feasibility study
Institute of Cancer Research (UK)0 个研究点目标入组 110 人开始时间: 2006年9月22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
- 110
研究概览
简要总结
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21406089 2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28453896
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Histologically confirmed Transitional Cell Carcinoma (TCC) of the bladder
- •2. Aged over 18 years
- •3. Clinical stage T2 or T3 N0 M0 (as classified by the TNM (Tumour, Nodes, Metastasis) Classification of the American Joint Committee on Cancer [AJCC])
- •4. World Health Organisation (WHO) performance status zero to one
- •5. Fit for radical cystectomy
- •6. Fit for radical radiotherapy
- •7. Receiving/received three cycles of gemcitabine-cisplatin or other protocol approved neo-adjuvant chemotherapy regimen and willing and fit to receive a fourth cycle according to study protocol
- •8. Satisfactory haematological profile (at time of chemotherapy administration):
- •a. Haemoglobin [Hb] more than 10 gms/dl
- •b. White Blood Cells (WBC) more than 3.0 x 10^9/L
- •c. Platelet count more than 150 x 10^9/L
- •9. Liver function tests (Bilirubin, Aspartate Aminotransferase [AST], Alkaline phosphatase less than 1.5 x Upper Limit of Normal [ULN])
- •10. Written informed consent and available for long-term follow-up
- •11. Patients receiving chemotherapy are expected to have a glomerular filtration rate more than 50 ml/min though this is not part of formal inclusion criteria
排除标准
- •1. Adenocarcinoma, Squamous Cell Carcinoma (SCC), small cell carcinoma or other variant histology (N.B. squamoid differentiation or mixed TCC/SCC is permitted)
- •2. Widespread Carcinoma In Situ (CIS) or CIS remote from muscle invasive tumour
- •3. Previous malignancy in the last five years except for adequately controlled non melanotic skin tumours, CIS of cervix or Lobular Carcinoma In Situ (LCIS) of breast
- •4. Pre-exisiting hydronephrosis
- •5. Previous pelvic radiotherapy
- •6. Any contra-indication to radical radiotherapy e.g. inflammatory bowel disease, radiosensitivity syndrome, severe diverticular disease
- •7. Bilateral total hip replacements
- •8. Pregnancy
- •9. Significant co-morbid medical conditions which would interfere with administration of any protocol treatment
研究者
相似试验
招募中
不适用
Selective bladder preservation with curative intent consisting of chemoradiotherapy plus partial cystectomy for muscle-invasive bladder cancerMuscle-invasive bladder cancerJPRN-UMIN000015076Department of Urology, Tokyo Medical and Dental University Graduate School200
招募中
2 期
Selective bladder preservation with curative intent consisting of induction chemoradiotherapy plus partial cystectomy for muscle-invasive bladder cancer: Phase II multicenter studyMuscle-invasive bladder cancerJPRN-UMIN000017739Department of Urology, Tokyo Medical and Dental University Graduate School80
Unknown
不适用
Transurethral Ventral Wall of Urethra-preserving Enucleation of ProstateBenign Prostatic HyperplasiaNCT01073241Southwest Hospital, China200
尚未招募
不适用
comparison between a bladder sparing approach and a radical cystectomy in patients with a non-metastasized muscle invasive bladder carcinomablaaskanker, spierinvasiefbladder cancer, muscle invasiveNL-OMON25055Amsterdam UMC, AMC1,000
已完成
不适用
BRAVO Study: Surgery vs. Immunotherapy – Which treatment is best in bladder cancer?Specialty: Cancer, Primary sub-specialty: BladderUKCRC code/ Disease: Cancer/ Malignant neoplasms of urinary tractCancerBladder cancerISRCTN12509361Sheffield Teaching Hospitals NHS Foundation Trust50