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Some available passages were not fully assessed for clinician views, so absence from an aspect is not proof that the issue was never discussed.","Some spoken passages cannot be assigned to a named participant. They may belong to a named participant in the same program and must not be counted as additional voices.","A relay preserves another party's statement; it does not establish that the relayer independently endorses the interpretation. Research involvement, professional identity or an organizational account does not increase evidentiary weight.","The discussions span different evidence maturities, populations and treatment-access circumstances. Approval, reimbursement, investigational status and anticipated readouts are time-specific, not a current comprehensive regulatory assessment.","S1314 was not designed to settle all secondary regimen or response–survival comparisons, and reduced biomarker evaluability limits precision. Nonsignificance is not equivalence, and prognostic association is not proof of treatment-selection benefit.","Gene-panel descriptions, unusual regimen wording and methylation performance percentages are not fully consistent across sources. The report preserves those differences rather than selecting an unverified correction.","Unclear wording about patients not proceeding to surgery does not establish progression, toxicity or another specific clinical 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MVAC"]],"enrollment":{"count":237,"type":"ACTUAL"},"interventions":[{"name":"Gemcitabine","synonyms":["Gemzar"],"type":"DRUG"},{"name":"Cisplatin","synonyms":["Platinol"],"type":"DRUG"},{"name":"Methotrexate","synonyms":["Trexall"],"type":"DRUG"},{"name":"Vinblastine","synonyms":["Velban"],"type":"DRUG"},{"name":"Doxorubicin","synonyms":["Adriamycin"],"type":"DRUG"},{"name":"Filgrastim","synonyms":["Neupogen"],"type":"DRUG"}],"nct_id":"NCT02177695","official_title":"A Randomized Phase II Study of Co-Expression Extrapolation (COXEN) With Neoadjuvant Chemotherapy for Localized, Muscle-Invasive Bladder Cancer","other_names":[{"kind":"also","name":"SWOG S1314"}],"overall_status":"COMPLETED","phase":["PHASE2"],"primary_completion_date":{"date":"2020-02","type":"ACTUAL"},"primary_endpoints":[{"description":"The proportion of participants achieving pT0 in both favorable and unfavorable treatment specific-COXEN score categories. Unit of measure is the number of participants in each category that achieved pT0 \\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_ The relationship of dose-dense methotrexate, vinblastin, doxorubicin, and cisplatin (DDMVAC)- and gemcitabine+cisplatin (GC)- specific CO-eXpression ExtrapolatioN (COXEN) scores This will be done in two ways: * By assessing whether the treatment-specific COXEN score is prognostic of pT0 rate or ≤ pT1 in this patient population and to assess in a preliminary fashion whether the COXEN score is a predictive factor distinguishing between these two chemotherapy regimens. . * By evaluating the correlation between the GC- and the DDMVAC-COXEN score.","measure":"Assessment of Whether the Treatment-specific COXEN Score is Prognostic of pT0 Rate","timeFrame":"Up to 5 years post registration"},{"description":"The proportion of participants achieving \\<=pT1 in both favorable and unfavorable treatment specific-COXEN score categories. Unit of measure is the number of participants in each category that achieved \\<= pT1 \\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_ The relationship of dose-dense methotrexate, vinblastin, doxorubicin, and cisplatin (DDMVAC)- and gemcitabine+cisplatin (GC)- specific CO-eXpression ExtrapolatioN (COXEN) scores This will be done in two ways: * By assessing whether the treatment-specific COXEN score is prognostic of pT0 rate or ≤ pT1 in this patient population and to assess in a preliminary fashion whether the COXEN score is a predictive factor distinguishing between these two chemotherapy regimens. . * By evaluating the correlation between the GC- and the DDMVAC-COXEN score.","measure":"Assessment of Whether the Treatment-specific COXEN Score is Prognostic of ≤ pT1 Rate","timeFrame":"up to 5 years post-registration"},{"description":"To assess in a hypothesis generating fashion, the ability of COXEN to select for an individual chemotherapy regimen (GC vs DDMVAC) P-values are reported as a measure of whether COXEN can select between GC/DDMVAC and to determine the significance of interactions between treatment specific COXEN scores and treatment arms in models predicting either pT0 or \\<= pT1. Interactions with p-values \\> 0.05 are interpreted as not significant. \\_\\_\\_\\_\\_\\_\\_\\_ The relationship of dose-dense methotrexate, vinblastin, doxorubicin, and cisplatin (DDMVAC)- and gemcitabine+cisplatin (GC)- specific CO-eXpression ExtrapolatioN (COXEN) scores This will be done in two ways: * By assessing whether the treatment-specific COXEN score is prognostic of pT0 rate or ≤ pT1 in this patient population and to assess in a preliminary fashion whether the COXEN score is a predictive factor distinguishing between these two chemotherapy regimens. . * By evaluating the correlation between the GC- and the DDMVAC-COXEN score.","measure":"Assessment of COXEN Score as a Predictive Factor Distinguishing Between GC and ddMVAC","timeFrame":"up to 5 years post-registration"},{"description":"The Pearson and Spearman correlation coefficients for GC-and ddMVAC-COXEN score were calculated and are reported below. \\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_ The relationship of dose-dense methotrexate, vinblastin, doxorubicin, and cisplatin (DDMVAC)- and gemcitabine+cisplatin (GC)- specific CO-eXpression ExtrapolatioN (COXEN) scores This will be done in two ways: * By assessing whether the treatment-specific COXEN score is prognostic of pT0 rate or ≤ pT1 in this patient population and to assess in a preliminary fashion whether the COXEN score is a predictive factor distinguishing between these two chemotherapy regimens. . * By evaluating the correlation between the GC- and the DDMVAC-COXEN score.","measure":"Correlation Between GC-and ddMVAC-COXEN Score","timeFrame":"up to 5 years post-registration"}],"registered_date":{"date":"2014-06-30","type":"ESTIMATED"},"registry_last_updated":"2024-09-19","registry_url":"https://clinicaltrials.gov/study/NCT02177695","short_name":"COXEN","short_name_basis":"registry_acronym","sponsor":"SWOG Cancer Research Network","start_date":{"date":"2014-08-28","type":"ACTUAL"},"study_design":"interventional, randomized, parallel, phase2","study_ids":[{"id":"S1314","type":"sponsor_study_id"},{"domain":"National Cancer Institute","id":"NCI-2014-00850","type":"other"},{"id":"U10CA180888","type":"nih"}],"study_type":"INTERVENTIONAL"}}}