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

Individual Sponsor (UK)0 个研究点目标入组 458 人开始时间: 2001年7月1日最近更新: 2022年5月30日

适应症

试验速览

•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)

•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

发起方

Individual Sponsor (UK)