{"preliminary_commentary":{"by_channel":{"x_thread":5},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"name":"A031701","nct_id":"NCT03609216","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=a031701-nct03609216. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Participants receive gemcitabine hydrochloride IV over 30 minutes on day 1, cisplatin IV on days 1 and 2, and pegfilgrastim SC on day 3. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unaccepted toxicity. Participants with DDR gene alteration and disease stage \\< cT1 undergo bladder sparing.","label":"Arm I (gemcitabine, cisplatin, bladder sparing)","type":"EXPERIMENTAL"},{"description":"Participants receive gemcitabine hydrochloride IV over 30 minutes on day 1, cisplatin IV on days 1 and 2, and pegfilgrastim SC on day 3. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unaccepted toxicity. Participants with DDR gene alteration and disease stage \\>= cT1 or participants without DDR gene alteration undergo radical cystectomy or chemoradiotherapy.","label":"Arm II (gemcitabine, cisplatin, cystectomy, chemoradiotherapy)","type":"EXPERIMENTAL"}],"collaborators":["National Cancer Institute (NCI)"],"completion_date":{"date":"2030-10-14","type":"ESTIMATED"},"conditions":["Infiltrating Bladder Urothelial Carcinoma","Stage II Bladder Urothelial Carcinoma","Stage III Bladder Urothelial Carcinoma"],"enrollment":{"count":237,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Gemcitabine Hydrochloride","otherNames":[],"type":"DRUG"},{"name":"Cisplatin","otherNames":[],"type":"DRUG"},{"name":"Pegfilgrastim","otherNames":[],"type":"BIOLOGICAL"},{"name":"Conventional Surgery","otherNames":[],"type":"PROCEDURE"},{"name":"Radical Cystectomy","otherNames":[],"type":"PROCEDURE"},{"name":"Chemoradiotherapy","otherNames":[],"type":"OTHER"}],"last_update":"2026-10-16","lead_sponsor":"Alliance for Clinical Trials in Oncology","official_title":"A Phase II Study of Gemcitabine Plus Cisplatin Chemotherapy in Patients With Muscle-invasive Bladder Cancer With Bladder Preservation for Those Patients Whose Tumors Harbor Deleterious DNA Damage Response (DDR) Gene Alterations","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2028-10-14","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Proportion of patients who are recurrence-free within the DDR mutated group who undergo the bladder sparing approach","timeFrame":"At 3 years"}],"references":[],"start_date":{"date":"2018-12-10","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Gemcitabine and Cisplatin Without Cystectomy for Patients With Muscle Invasive Bladder Urothelial Cancer and Select Genetic Alterations","url":"https://clinicaltrials.gov/study/NCT03609216"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/a031701-nct03609216"}