{"preliminary_commentary":{"by_channel":{"x_thread":3},"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":false},"name":"NCT04216290","nct_id":"NCT04216290","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct04216290. 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":"Patients undergo radiation therapy for 6.5-8 weeks. Beginning 4 days before or after starting radiation therapy, patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Beginning 4 days before or after starting radiation therapy, patients also receive gemcitabine hydrochloride IV over 30-60 minutes BIW for 6 weeks; or cisplatin IV over 30-60 minutes QW for 6 weeks; or mitomycin IV over 30 minutes on day 1 of radiation and fluorouracil IV continuous infusion on days 1-5 and 16-20 of radiation in the absence of disease progression or unacceptable toxicity. Patients also undergo bladder biopsy on study, cystoscopy on study and during follow-up, as well as CT or MRI throughout the trial. Patients may also undergo tumor tissue and blood sample collection on study.","label":"Step 1, Arm C (durvalumab, radiation therapy, chemotherapy)","type":"EXPERIMENTAL"},{"description":"Patients undergo radiation therapy for 6.5-8 weeks. Beginning 4 days before or after starting radiation therapy, patients also receive gemcitabine hydrochloride IV over 30-60 minutes BIW for 6 weeks; or cisplatin IV over 30-60 minutes QW for 6 weeks; or mitomycin IV over 30 minutes on day 1 of radiation and fluorouracil IV continuous infusion on days 1-5 and 16-20 of radiation in the absence of disease progression or unacceptable toxicity. Patients also undergo bladder biopsy on study, cystoscopy on study and during follow-up, as well as CT or MRI throughout the trial. Patients may also undergo tumor tissue and blood sample collection on study.","label":"Step 1, Arm D (radiation therapy, chemotherapy)","type":"ACTIVE_COMPARATOR"},{"description":"Patients previously randomized to Arm C (chemoradiation and durvalumab) who achieve clinical CR or clinical benefit receive durvalumab IV over 60 minutes on day 1 of each cycle. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo bladder biopsy on study, cystoscopy on study and during follow-up, as well as CT or MRI throughout the trial. Patients may also undergo tumor tissue and blood sample collection on study.","label":"Step 2, Arm E (durvalumab)","type":"EXPERIMENTAL"},{"description":"Patients previously randomized to Arm D (chemoradiation) who achieve clinical CR or clinical benefit undergo observation undergo observation. Patients also undergo bladder biopsy on study, cystoscopy on study and during follow-up, as well as CT or MRI throughout the trial. Patients may also undergo tumor tissue and blood sample collection on study.","label":"Step 2, Arm F (observation)","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2027-05-19","type":"ESTIMATED"},"conditions":["Bladder Urothelial Carcinoma","Stage III Bladder Cancer AJCC v8"],"enrollment":{"count":11,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Biopsy of Bladder","otherNames":["Bladder Biopsy"],"type":"PROCEDURE"},{"name":"Biospecimen Collection","otherNames":["Biological Sample Collection","Biospecimen Collected","Sample Collection","Specimen Collection"],"type":"PROCEDURE"},{"name":"Cisplatin","otherNames":["Abiplatin","Blastolem","Briplatin","CDDP","Cis-diammine-dichloroplatinum","Cis-diamminedichloridoplatinum","Cis-diamminedichloro Platinum (II)","Cis-diamminedichloroplatinum","Cis-dichloroammine Platinum (II)","Cis-platinous Diamine Dichloride","Cis-platinum","Cis-platinum II","Cis-platinum II Diamine Dichloride","Cismaplat","Cisplatina","Cisplatinum","Cisplatyl","Citoplatino","Citosin","Cysplatyna","DDP","Lederplatin","Metaplatin","Neoplatin","Peyrone's Chloride","Peyrone's Salt","Placis","Plastistil","Platamine","Platiblastin","Platiblastin-S","Platinex","Platinol","Platinol- AQ","Platinol-AQ","Platinol-AQ VHA Plus","Platinoxan","Platinum","Platinum Diamminodichloride","Platiran","Platistin","Platosin"],"type":"DRUG"},{"name":"Computed Tomography","otherNames":["CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","Computerized Tomography (CT) scan","CT","CT Scan","Diagnostic CAT Scan","Diagnostic CAT Scan Service Type","tomography"],"type":"PROCEDURE"},{"name":"Cystoscopy","otherNames":["CS"],"type":"PROCEDURE"},{"name":"Durvalumab","otherNames":["Imfinzi","Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer","MEDI 4736","MEDI-4736","MEDI4736"],"type":"BIOLOGICAL"},{"name":"Fluorouracil","otherNames":["5 Fluorouracil","5 Fluorouracilum","5 FU","5-Fluoro-2,4(1H, 3H)-pyrimidinedione","5-Fluorouracil","5-Fluracil","5-Fu","5FU","AccuSite","Carac","Fluoro Uracil","Fluouracil","Flurablastin","Fluracedyl","Fluracil","Fluril","Fluroblastin","Ribofluor","Ro 2-9757","Ro-2-9757"],"type":"DRUG"},{"name":"Gemcitabine Hydrochloride","otherNames":["dFdCyd","Difluorodeoxycytidine Hydrochloride","Gemcitabine HCI","Gemzar","LY 188011","LY-188011","LY188011"],"type":"DRUG"},{"name":"Magnetic Resonance Imaging","otherNames":["Magnetic Resonance","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","MRIs","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging","sMRI","Structural MRI"],"type":"PROCEDURE"},{"name":"Mitomycin","otherNames":["Ametycine","Jelmyto","MITO","Mito-C","Mito-Medac","Mitocin","Mitocin-C","Mitolem","Mitomycin C","Mitomycin pyelocalyceal","Mitomycin-C","Mitomycin-X","Mitomycine C","Mitosol","Mitozytrex","Mutamycin","Mutamycine","NCI-C04706"],"type":"DRUG"},{"name":"Patient Observation","otherNames":["Active Surveillance","deferred therapy","expectant management","Observation","Watchful Waiting"],"type":"OTHER"},{"name":"Radiation Therapy","otherNames":["Cancer Radiotherapy","Energy Type","ENERGY_TYPE","Irradiate","Irradiated","Irradiation","Radiation","Radiation Therapy, NOS","Radiotherapeutics","Radiotherapy","RT","Therapy, Radiation"],"type":"RADIATION"}],"last_update":"2026-05-22","lead_sponsor":"National Cancer Institute (NCI)","official_title":"Phase II Study of Bladder-SparIng ChemoradiatioN With Durvalumab in Clinical Stage III, Node PosItive BladdeR CancEr (INSPIRE)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2026-02-04","type":"ACTUAL"},"primary_outcomes":[{"measure":"Clinical complete response (CR)","timeFrame":"Up to 4 years"}],"references":[],"start_date":{"date":"2021-03-17","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Chemotherapy and Radiation Therapy Compared to Chemotherapy and Radiation Therapy Plus MEDI4736 (Durvalumab) Immunotherapy for Bladder Cancer Which Has Spread to the Lymph Nodes, INSPIRE Trial","url":"https://clinicaltrials.gov/study/NCT04216290"},"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/nct04216290"}