{"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":"POLEM","nct_id":"NCT03827044","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=polem-nct03827044. 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":"POLEM","arms":[{"description":"6 months of 2 weekly Avelumab","label":"Avelumab","type":"EXPERIMENTAL"},{"description":"After standard adjuvant 5FU based chemotherapy, patients will have no active intervention but will start standard follow up.","label":"No intervention","type":"NO_INTERVENTION"}],"collaborators":["University of Surrey","University of Oxford","Merck KGaA, Darmstadt, Germany"],"completion_date":{"date":"2022-01-05","type":"ACTUAL"},"conditions":["POLE Exonuclease Mutant Colon Cancer","Microsatellite Instability","Stage III Colon Cancer"],"enrollment":{"count":30,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Avelumab","otherNames":["Bavencio"],"type":"DRUG"}],"last_update":"2022-10-07","lead_sponsor":"Royal Marsden NHS Foundation Trust","official_title":"POLEM:Avelumab Plus 5-FU Based Chemotherapy as Adjuvant Treatment for Stage 3 MSI-High or POLE Exonuclease Domain Mutant Colon Cancer: A Phase 3 Randomised Study","overall_status":"TERMINATED","phases":["PHASE3"],"primary_completion_date":{"date":"2021-01-05","type":"ACTUAL"},"primary_outcomes":[{"measure":"Primary End point: Disease Free survival","timeFrame":"3 years"}],"references":[{"citation":"Lau D, Kalaitzaki E, Church DN, Pandha H, Tomlinson I, Annels N, Gerlinger M, Sclafani F, Smith G, Begum R, Crux R, Gillbanks A, Wordsworth S, Chau I, Starling N, Cunningham D, Dhillon T. Rationale and design of the POLEM trial: avelumab plus fluoropyrimidine-based chemotherapy as adjuvant treatment for stage III mismatch repair deficient or POLE exonuclease domain mutant colon cancer: a phase III randomised study. ESMO Open. 2020 Feb;5(1):e000638. doi: 10.1136/esmoopen-2019-000638.","pmid":"32079623","type":"DERIVED"}],"start_date":{"date":"2018-08-31","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Avelumab Plus 5-FU Based Chemotherapy as Adjuvant Treatment for Stage 3 MSI-High or POLE Mutant Colon Cancer","url":"https://clinicaltrials.gov/study/NCT03827044"},"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/polem-nct03827044"}