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

Conditions

Bladder (advanced) Cancer

Hall E, Hussain SA, Porta N, Lewis R, Crundwell M, Jenkins P, Rawlings C, Tremlett J, Sreenivasan T, Wallace J, Syndikus I, Sheehan D, Lydon A, Huddart R, James N, BC2001 Investigators.

2022-05-1473 citations

10.1016/j.eururo.2022.04.017

Protocol for tumour-focused dose-escalated adaptive radiotherapy for the radical treatment of bladder cancer in a multicentre phase II randomised controlled trial (RAIDER): radiotherapy planning and delivery guidance

S. Hafeez, Amanda Webster, Vibeke N. Hansen, H. McNair, K. Warren-Oseni et al. (20 authors)

BMJ Open2020-12-0134 citations

10.1136/bmjopen-2020-041005

BC2001 long-term outcomes: A phase III randomized trial of chemoradiotherapy versus radiotherapy (RT) alone and standard RT versus reduced high-dose volume RT in muscle-invasive bladder cancer.

Emma Hall, Syed A. Hussain, Núria Porta, Malcolm Crundwell, Peter Jenkins et al. (13 authors)

Journal of Clinical Oncology2017-02-2019 citations

10.1200/jco.2017.35.6_suppl.280

Outcome of BC2001 patients (CRUK/01/004) who received neoadjuvant chemotherapy prior to randomization to chemo-radiotherapy (cRT) versus radiotherapy (RT).

Syed A. Hussain, Emma Hall, Núria Porta, Malcolm Crundwell, Peter Jenkins et al. (12 authors)

Journal of Clinical Oncology2017-02-202 citations

10.1200/jco.2017.35.6_suppl.298

Radiotherapy with or without chemotherapy in muscle-invasive bladder cancer.

James ND, Hussain SA, Hall E, Jenkins P, Tremlett J, Rawlings C, Crundwell M, Sizer B, Sreenivasan T, Hendron C, Lewis R, Waters R, Huddart RA, BC2001 Investigators.

2012-04-01648 citations

10.1056/nejmoa1106106

Interventions

Four possible randomisations as follows: 1. Synchronous 5-Fluorouracil (5-FU) and Mitomycin with standard radiotherapy (to the whole bladder) 2. Synchronous 5-FU and Mi

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Secondary endpoint: 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. Tertiary endpoints: 1. Acute toxicity 2. Cystoscopic local control at 6 months, 1 year and 2 years post randomisation 3. Rate of salvage cystectomy 4. Overall survival	—

Measure

Time frame

Secondary endpoint: 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. Tertiary endpoints: 1. Acute toxicity 2. Cystoscopic local control at 6 months, 1 year and 2 years post randomisation 3. Rate of salvage cystectomy 4. Overall survival

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Countries

England, United Kingdom

Outcome results

None listed