{"preliminary_commentary":{"by_channel":{"x_thread":3},"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,"drugs_tested":null,"indication":"recurrent BCG-exposed high-grade non-muscle-invasive bladder cancer","name":"GAIN-BCG","nct_id":"NCT07000084","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=gain-bcg-nct07000084. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. 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_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"GAIN-BCG","arms":[{"description":"Patients receive BCG intravesically over 2 hours QW for 6 weeks. 2-6 weeks after completing endoscopic assessment, patients receive BCG over 2 hours QW for 3 weeks at month 3, 6 and 12 in the absence of disease progression or unacceptable toxicity. Patients undergo bladder biopsy, TURBT, cystoscopy, CT scan/MRI and blood and urine sample collection throughout the study.","label":"Arm A (BCG)","type":"ACTIVE_COMPARATOR"},{"description":"Patients receive gemcitabe intravesically over 1 hour twice weekly on weeks 1 and 10 and once weekly on weeks 4 and 7. Patients also receive BCG intravesically over 2 hours QW on weeks 2, 3, 6, 8 and 9. 2-6 weeks after completing endoscopic assessment, patients receive gemcitable intravesically over 1 hour on week 1 and BCG intravesically over 2 hours on week 2-4 at month 3, 6 and 12 in the absence of disease progression or unacceptable toxicity. Patients undergo bladder biopsy, TURBT, cystoscopy, CT scan/MRI and blood and urine sample collection throughout the study.","label":"Arm B (BCG and gemcitabine)","type":"EXPERIMENTAL"}],"collaborators":["National Cancer Institute (NCI)"],"completion_date":{"date":"2028-12-05","type":"ESTIMATED"},"conditions":["Recurrent Non-Muscle Invasive Bladder Carcinoma","Stage 0a Bladder Cancer AJCC v8","Stage I Bladder Cancer AJCC v8"],"enrollment":{"count":330,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"BCG Solution","otherNames":["Bacillus Calmette Guerin Solution"],"type":"BIOLOGICAL"},{"name":"Biopsy of Bladder","otherNames":["Bladder Biopsy"],"type":"PROCEDURE"},{"name":"Cystoscopy","otherNames":[],"type":"PROCEDURE"},{"name":"Computed Tomography","otherNames":["CAT Scan","CT Scan"],"type":"PROCEDURE"},{"name":"Magnetic Resonance Imaging","otherNames":["MRI"],"type":"PROCEDURE"},{"name":"Biospecimen Collection","otherNames":[],"type":"PROCEDURE"},{"name":"Transurethral Resection of Bladder Tumor","otherNames":["TURBT"],"type":"PROCEDURE"},{"name":"Gemcitabine","otherNames":[],"type":"DRUG"}],"last_update":"2026-10-02","lead_sponsor":"Alliance for Clinical Trials in Oncology","official_title":"GAIN-BCG: Gemcitabine Alternating With INtravesical BCG Randomized Against BCG Alone for Patients With Recurrent High Grade Non-Muscle Invasive Bladder Cancer","overall_status":"RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2028-06-05","type":"ESTIMATED"},"primary_outcomes":[{"measure":"High Grade Recurrence-free survival (HG-RFS)","timeFrame":"Up to 5 years"}],"references":[{"citation":"Gaffney CD, Alam SM, Wald G, Sjoberg D, Eichholz J, Sarungbam J, D'Souza N, Lavery J, Hernandez C, Tomerlein M, Zagajeski P, Hildreth KW, Donat S, Smith R, Donahue T, Goh A, Bochner B, Al-Ahmadie H, Pietzak E. A Phase I Clinical Trial of Chemoimmunotherapy with Alternating Intravesical Gemcitabine and Bacillus Calmette-Guerin (GemBCG) for BCG-Exposed High-Grade Non-Muscle-Invasive Bladder Cancer. J Urol. 2026 Oct 1:101097JU0000000000005324. doi: 10.1097/JU.0000000000005324. Online ahead of print.","pmid":"42821609","type":"DERIVED"}],"start_date":{"date":"2025-07-17","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Testing the Addition of an Anti-Cancer Drug, Gemcitabine, to Usual Treatment (BCG Alone) in People Whose Non-Muscle Invasive Bladder Cancer (NMIBC) Came Back After Prior BCG Therapy","url":"https://clinicaltrials.gov/study/NCT07000084"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/gain-bcg-nct07000084"}