Randomised trial of Selective bladder Preservation Against Radical Excision (cystectomy) in muscle invasive T2/T3 transitional cell carcinoma of the bladder: a feasibility study

Phase 3

Completed

• Conditions: Muscle Invasive Bladder Cancer; Cancer

• Registration Number: ISRCTN61126465
• Lead Sponsor: Institute of Cancer Research (UK)

Brief Summary

2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21406089 2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28453896

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-09-22
• Study Completion: 2010-02-12
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Feasibility Study:<br> 1. Number of patients randomised over two years<br> 2. Proportion of patients undergoing bladder preservation in SBP arm<br> 3. Proportion of patients undergoing cystectomy in surgery arm<br><br> Main Trial:<br> 1. Overall survival<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Compliance with randomised treatment<br> 2. Rate of salvage cystectomy after bladder preservation<br> 3. Toxicity<br> 4. Quality of life<br> 5. Loco-regional progression free, metastasis free<br> 6. Overall survival<br>