2x2 factorial randomised phase III study comparing standard versus whole bladder volume radiotherapy with and without synchronous chemotherapy in muscle invasive bladder cancer

Not Applicable

Completed

• Conditions: Bladder (advanced); Cancer

• Registration Number: ISRCTN68324339
• Lead Sponsor: Individual Sponsor (UK)

Brief Summary

2012 Results article in http://www.ncbi.nlm.nih.gov/pubmed/22512481 results 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23958147 results 2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25445550 results 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35577644/ (added 18/05/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2001-07-01
• Study Completion: 2011-08-31
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 458

Inclusion Criteria

1. Aged 18 or over
2. Histologically proven invasive bladder carcinoma (adenocarcinoma, transitional or squamous cell carcinoma)
3. Localised muscle invasive carcinoma either surgically or by imaging (T2-T4a, N0, M0)
4. Patients with multiple tumours at the time of randomisation are not eligible for the radiotherapy volume randomisation but may be randomised to whole bladder radiotherapy with or without chemotherapy
5. World Health Organisation (WHO) performance status 0-2 Leucocytes >4.0 x 10(9)/ l; Platelets >100 x 10(9)/l Glomerular filtration rate (GFR) >25 ml/min Serum bilirubin <1.5 upper limit of reference range (ULRR) alanine amino transferase (ALT) or aspartate amino transferase (AST) <1.5 x ULRR
6. Patient available for long term follow up and in the opinion of the investigator, able to receive radical radiotherapy
7. Patients written informed consent
8. Able to understand and complete the QoL questionnaire (patient can enter study without QoL but ALL are invited)

Exclusion Criteria

1. Uncontrolled systemic disease which would preclude the patient from the study
2. Pregnancy
3. Other malignancy within the previous 2 years (other than adequately treated BCC of the skin or adequately treated in situ carcinoma of the cervix uteri)
4. Previous malignancy that is likely to interfere with protocol treatment
5. Inflammatory bowel disease
6. Previous pelvic radiotherapy
7. Bilateral hip replacements compromising accurate radiotherapy planning

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Added 02/06/2011:<br> Loco-regional (Ui.e. pelvic nodes & bladderU) disease free survival. The particular time point of interest is 2 years post randomisation<br>

Secondary Outcome Measures

Name	Time	Method
<br> Secondary endpoint:<br> Disease free survival, Metastases free survival, Late toxicity at 1 and 2 years as assessed by RTOG and Lent Som toxicity scores, bladder capacity and Fact-BL QoL score. This endpoint is of particular importance in the radiotherapy comparison.<br><br> Tertiary endpoints:<br> 1. Acute toxicity<br> 2. Cystoscopic local control at 6 months, 1 year and 2 years post randomisation<br> 3. Rate of salvage cystectomy<br> 4. Overall survival<br>