Phase 3 BRIDGE trial to compare GEM/DOC vs BCG

7 months 2 weeks ago #61985 by Shacky73
Replied by Shacky73 on topic Phase 3 BRIDGE trial to compare GEM/DOC vs BCG
Why would they use GEM/DOC monthly after induction?  Does that infer a therapeutic efficacy less than BCG?

T1 Grade 3 with CIS

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7 months 4 weeks ago #61960 by sara.anne
Replied by sara.anne on topic Phase 3 BRIDGE trial to compare GEM/DOC vs BCG
Thank you for posting this, Joe!!  

Usually the clinical trials that we see are rather specialized and don't apply to many of us.  This one looks as if it would apply to a lot of us.............and the number of participating locations is amazing.  I hope that those of us waiting for BCG will investigate participating.

Sara Anne

Diagnosis 2-08 Small papillary TCC; CIS
BCG; BCG maintenance
Vice-President, American Bladder Cancer Society
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7 months 4 weeks ago #61959 by joea73
By now, we became familiar with Gemcitabine and Docetaxel (GEM/DOC) sequential treatment for BCG unresponsive and alternative to BCG when BCG is in shortage.   Several participants on this forum posted their experience wit GEM/DOC including its efficacy and side effects.  Also retrospective studies often conducted by University of Iowa team who developed the GEM/DOC treatment protocol and tested its efficacy for BCG naive and BCG experienced patients with very good outcomes.  But, those studies did not include randomized comparisons between GEM/DOC and BCG.  Phase 3 BRIDGE trial plans to recruit about1000 patients and test sites are located several states, with Colorado hosting the most test sites (19).   Participants will be followed for 5 years after the completion of the treatment.  Patients who are selected for BCG will received usual 6 weeks induction + 3 weeks maintenance at months 3,6,12,18,24, 30. Patients with GEM/DOC will  receive treatment of 6 weeks + monthly for up to 2 year.  The completion of the trial is expected to be in 2029.  

medicine.uiowa.edu/content/alternative-bladder-cancer-treatment-emerges-amid-worldwide-shortage-standard-care-bcg

www.cancer.gov/about-cancer/treatment/clinical-trials/search/v?id=NCI-2022-04864&r=1

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