BCG+MMC trial: adding mitomycin C to BCG as adjuvant intravesical therapy for high-risk, non-muscle-invasive bladder cancer: a randomised phase III trial (ANZUP 1301)

BMC Cancer

Study Protocol

Shomik Sengupta¹  Ian D. Davis²  Andrew Martin³  Martin Stockler³  Anne Long³  Venu Chalasani⁴  Dickon Hayne⁵  Steve P. McCombie⁵ 

[1] Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP), 1450, Camperdown, NSW, Australia;Department of Urology, Austin Health, 3084, Melbourne, VIC, Australia;Austin Department of Surgery, University of Melbourne, 3010, Melbourne, VIC, Australia;Ludwig Institute for Cancer Research, Austin Hospital, 3084, Melbourne, VIC, Australia;Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP), 1450, Camperdown, NSW, Australia;Monash University Eastern Health Clinical School, Box Hill, 3128, Melbourne, VIC, Australia;Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP), 1450, Camperdown, NSW, Australia;NHMRC Clinical Trials Centre, University of Sydney, 2050, Sydney, NSW, Australia;Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP), 1450, Camperdown, NSW, Australia;NHMRC Clinical Trials Centre, University of Sydney, 2050, Sydney, NSW, Australia;Department of Urology, Hornsby Ku-Ring-Gai Hospital, 2077, Sydney, NSW, Australia;Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP), 1450, Camperdown, NSW, Australia;School of Surgery, University of Western Australia, 6009, Crawley, WA, Australia;Fiona Stanley Hospital Urology (proudly supported by WAURO), 6150, Murdoch, WA, Australia;

关键词: Bladder cancer;    Transitional cell carcinoma;    Intravesical;    BCG;    Mitomycin;   

DOI  :  10.1186/s12885-015-1431-6

 received in 2015-02-28, accepted in 2015-05-13,  发布年份 2015

来源: Springer

【 摘 要 】

BackgroundDespite adequate trans-urethral resection of the bladder tumour (TURBT), non-muscle-invasive bladder cancer (NMIBC) is associated with high rates of recurrence and progression. Instillation of Bacillus Calmette-Guérin (BCG) into the urinary bladder after TURBT (adjuvant intravesical administration) reduces the risk of both recurrence and progression, and this is therefore the standard of care for high-risk tumours. However, over 30 % of people still recur or progress despite optimal delivery of BCG. Our meta-analysis suggests that outcomes might be improved further by using an adjuvant intravesical regimen that includes both mitomycin and BCG. These promising findings require corroboration in a definitive, large scale, randomised phase III trial using standard techniques for intravesical administration.Methods and designThe BCG + MMC trial (ANZUP 1301) is an open-label, randomised, stratified, two-arm multi-centre phase III trial comparing the efficacy and safety of standard intravesical therapy (BCG alone) against experimental intravesical therapy (BCG and mitomycin) in the treatment of adults with resected, high-risk NMIBC. Participants in the control group receive standard treatment with induction (weekly BCG for six weeks) followed by maintenance (four-weekly BCG for ten months). Participants in the experimental group receive induction (BCG weeks 1, 2, 4, 5, 7, and 8; mitomycin weeks 3, 6, and 9) followed by four-weekly maintenance (mitomycin weeks 13, 17, 25, 29, 37, and 41; BCG weeks 21, 33, and 45). The trial aims to include 500 participants who will be centrally randomised to one of the two treatment groups in a 1:1 ratio stratified by T-stage, presence of CIS, and study site. The primary endpoint is disease-free survival; secondary endpoints are disease activity, time to recurrence, time to progression, safety, health-related quality of life, overall survival, feasibility, and resource use.Trial registrationThis trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12613000513718).

【 授权许可】

CC BY   
© Hayne et al.; licensee BioMed Central. 2015