{"preliminary_commentary":{"by_channel":{"x_thread":7,"youtube":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT02177695\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"name":"COXEN","nct_id":"NCT02177695","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=coxen-nct02177695. 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":"COXEN","arms":[{"description":"Gemcitabine, 1000 mg/m2, IV, Days 1\\&8, q 21 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1, q 21 days x 4 cycles","label":"Gemcitabine & Cisplatin","type":"EXPERIMENTAL"},{"description":"Methotrexate, 30 mg/m2, IV, Day 1, q 14 days x 4 cycles Vinblastine, 3 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Doxorubicin, 30 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Filgrastim, 5 mcg/kg, SubQ/IV, Days 3-7, q 14 days x 4 cycles","label":"Dose Dense MVAC","type":"EXPERIMENTAL"}],"collaborators":["National Cancer Institute (NCI)"],"completion_date":{"date":"2022-12-01","type":"ACTUAL"},"conditions":["Bladder Cancer"],"enrollment":{"count":237,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Gemcitabine","otherNames":["Gemzar"],"type":"DRUG"},{"name":"Cisplatin","otherNames":["Platinol"],"type":"DRUG"},{"name":"Methotrexate","otherNames":["Trexall"],"type":"DRUG"},{"name":"Vinblastine","otherNames":["Velban"],"type":"DRUG"},{"name":"Doxorubicin","otherNames":["Adriamycin"],"type":"DRUG"},{"name":"Filgrastim","otherNames":["Neupogen"],"type":"DRUG"}],"last_update":"2024-09-19","lead_sponsor":"SWOG Cancer Research Network","official_title":"A Randomized Phase II Study of Co-Expression Extrapolation (COXEN) With Neoadjuvant Chemotherapy for Localized, Muscle-Invasive Bladder Cancer","overall_status":"COMPLETED","phases":["PHASE2"],"primary_completion_date":{"date":"2020-02","type":"ACTUAL"},"primary_outcomes":[{"measure":"Assessment of Whether the Treatment-specific COXEN Score is Prognostic of pT0 Rate","timeFrame":"Up to 5 years post registration"},{"measure":"Assessment of Whether the Treatment-specific COXEN Score is Prognostic of ≤ pT1 Rate","timeFrame":"up to 5 years post-registration"},{"measure":"Assessment of COXEN Score as a Predictive Factor Distinguishing Between GC and ddMVAC","timeFrame":"up to 5 years post-registration"},{"measure":"Correlation Between GC-and ddMVAC-COXEN Score","timeFrame":"up to 5 years post-registration"}],"references":[{"citation":"Bai Z, Osman M, Brendel M, Tangen CM, Flaig TW, Thompson IM, Plets M, Scott Lucia M, Theodorescu D, Gustafson D, Daneshmand S, Meeks JJ, Choi W, Dinney CPN, Elemento O, Lerner SP, McConkey DJ, Faltas BM, Wang F. Predicting response to neoadjuvant chemotherapy in muscle-invasive bladder cancer via interpretable multimodal deep learning. NPJ Digit Med. 2025 Mar 22;8(1):174. doi: 10.1038/s41746-025-01560-y.","pmid":"40121304","type":"DERIVED"},{"citation":"Flaig TW, Tangen CM, Daneshmand S, Alva AS, Lucia MS, McConkey DJ, Theodorescu D, Goldkorn A, Milowsky MI, Bangs R, MacVicar GR, Bastos BR, Fowles JS, Gustafson DL, Plets M, Thompson IM Jr, Lerner SP. Long-term Outcomes from a Phase 2 Study of Neoadjuvant Chemotherapy for Muscle-invasive Bladder Cancer (SWOG S1314; NCT02177695). Eur Urol. 2023 Sep;84(3):341-347. doi: 10.1016/j.eururo.2023.06.014. Epub 2023 Jul 4.","pmid":"37414705","type":"DERIVED"},{"citation":"Flaig TW, Tangen CM, Daneshmand S, Alva A, Lerner SP, Lucia MS, McConkey DJ, Theodorescu D, Goldkorn A, Milowsky MI, Bangs R, MacVicar GR, Bastos BR, Fowles JS, Gustafson DL, Plets M, Thompson IM Jr. A Randomized Phase II Study of Coexpression Extrapolation (COXEN) with Neoadjuvant Chemotherapy for Bladder Cancer (SWOG S1314; NCT02177695). Clin Cancer Res. 2021 May 1;27(9):2435-2441. doi: 10.1158/1078-0432.CCR-20-2409. Epub 2021 Feb 10.","pmid":"33568346","type":"DERIVED"}],"start_date":{"date":"2014-08-28","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"S1314, Co-expression Extrapolation (COXEN) Program to Predict Chemotherapy Response in Patients With Bladder Cancer","url":"https://clinicaltrials.gov/study/NCT02177695"},"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/coxen-nct02177695"}