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dc.contributor.authorHayne, D
dc.contributor.authorStockler, M
dc.contributor.authorMcCombie, SP
dc.contributor.authorChalasani, V
dc.contributor.authorLong, A
dc.contributor.authorMartin, A
dc.contributor.authorSengupta, S
dc.contributor.authorDavis, ID
dc.date.accessioned2021-02-05T01:29:20Z
dc.date.available2021-02-05T01:29:20Z
dc.date.issued2015-05-27
dc.identifierpii: 10.1186/s12885-015-1431-6
dc.identifier.citationHayne, D., Stockler, M., McCombie, S. P., Chalasani, V., Long, A., Martin, A., Sengupta, S. & Davis, I. D. (2015). BCG plus 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, 15 (1), https://doi.org/10.1186/s12885-015-1431-6.
dc.identifier.issn1471-2407
dc.identifier.urihttp://hdl.handle.net/11343/260417
dc.description.abstractBACKGROUND: Despite 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 DESIGN: The 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 REGISTRATION: This trial is registered with the Australian New Zealand Clinical Trials Registry ( ACTRN12613000513718 ).
dc.languageEnglish
dc.publisherBMC
dc.rights.urihttps://creativecommons.org/licenses/by/4.0
dc.titleBCG plus 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)
dc.typeJournal Article
dc.identifier.doi10.1186/s12885-015-1431-6
melbourne.affiliation.departmentMedicine (Austin & Northern Health)
melbourne.affiliation.facultyMedicine, Dentistry & Health Sciences
melbourne.source.titleBMC Cancer
melbourne.source.volume15
melbourne.source.issue1
dc.rights.licenseCC BY
melbourne.elementsid979704
melbourne.contributor.authorDavis, Ian
melbourne.contributor.authorSENGUPTA, SHOMIK
dc.identifier.eissn1471-2407
melbourne.accessrightsOpen Access


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