{"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":null,"name":"NCT02324452","nct_id":"NCT02324452","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct02324452. 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":null,"arms":[{"description":"Patients screened for four single nucleotide polymorphisms (SNPs) in DPYD (DPYD\\*2A, c.2846A\\>T, c.1236G\\>A/HapB3 and DPYD\\*13) that are found to be heterozygous for one of these SNPs","label":"heterozygous carrier of DPYD variant","type":"EXPERIMENTAL"},{"description":"Patients screened for four single nucleotide polymorphisms (SNPs) in DPYD (DPYD\\*2A, c.2846A\\>T, c.1236G\\>A/HapB3 and DPYD\\*13) that are found to be wild type for these SNPs","label":"wild type for DPYD","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2018-03","type":"ACTUAL"},"conditions":["Neoplasms"],"enrollment":{"count":1103,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Fluoropyrimidine (capecitabine or 5-fluorouracil)","otherNames":["Xeloda","Capecitabine","5-fluorouracil","fluorouracil","5-FU"],"type":"DRUG"}],"last_update":"2018-05-11","lead_sponsor":"The Netherlands Cancer Institute","official_title":"Safety, Feasibility and Cost-effectiveness of Genotype-directed Individualized Dosing of Fluoropyrimidines","overall_status":"COMPLETED","phases":["NA"],"primary_completion_date":{"date":"2018-01","type":"ACTUAL"},"primary_outcomes":[{"measure":"Safety: incidence of severe treatment-related toxicity (CTC grade 3 to 5)","timeFrame":"patients will be followed during fluoropyrimidine treatment, expected average of 1 year"}],"references":[{"citation":"Knikman JE, Lopez-Yurda M, Meulendijks D, Deenen MJ, Schellens JHM, Beijnen J, Cats A, Guchelaar HJ. A Nomogram to Predict Severe Toxicity in DPYD Wild-Type Patients Treated With Capecitabine-Based Anticancer Regimens. Clin Pharmacol Ther. 2024 Feb;115(2):269-277. doi: 10.1002/cpt.3100. Epub 2023 Nov 29.","pmid":"37957132","type":"DERIVED"},{"citation":"Knikman JE, Wilting TA, Lopez-Yurda M, Henricks LM, Lunenburg CATC, de Man FM, Meulendijks D, Nieboer P, Droogendijk HJ, Creemers GJ, Mandigers CMPW, Imholz ALT, Mathijssen RHJ, Portielje JEA, Valkenburg-van Iersel L, Vulink A, van der Poel MHW, Baars A, Swen JJ, Gelderblom H, Schellens JHM, Beijnen JH, Guchelaar HJ, Cats A. Survival of Patients With Cancer With DPYD Variant Alleles and Dose-Individualized Fluoropyrimidine Therapy-A Matched-Pair Analysis. J Clin Oncol. 2023 Dec 10;41(35):5411-5421. doi: 10.1200/JCO.22.02780. Epub 2023 Aug 28.","pmid":"37639651","type":"DERIVED"},{"citation":"Henricks LM, Lunenburg CATC, de Man FM, Meulendijks D, Frederix GWJ, Kienhuis E, Creemers GJ, Baars A, Dezentje VO, Imholz ALT, Jeurissen FJF, Portielje JEA, Jansen RLH, Hamberg P, Ten Tije AJ, Droogendijk HJ, Koopman M, Nieboer P, van de Poel MHW, Mandigers CMPW, Rosing H, Beijnen JH, Werkhoven EV, van Kuilenburg ABP, van Schaik RHN, Mathijssen RHJ, Swen JJ, Gelderblom H, Cats A, Guchelaar HJ, Schellens JHM. DPYD genotype-guided dose individualisation of fluoropyrimidine therapy in patients with cancer: a prospective safety analysis. Lancet Oncol. 2018 Nov;19(11):1459-1467. doi: 10.1016/S1470-2045(18)30686-7. Epub 2018 Oct 19.","pmid":"30348537","type":"DERIVED"},{"citation":"Jacobs BA, Deenen MJ, Pluim D, van Hasselt JG, Krahenbuhl MD, van Geel RM, de Vries N, Rosing H, Meulendijks D, Burylo AM, Cats A, Beijnen JH, Huitema AD, Schellens JH. Pronounced between-subject and circadian variability in thymidylate synthase and dihydropyrimidine dehydrogenase enzyme activity in human volunteers. Br J Clin Pharmacol. 2016 Sep;82(3):706-16. doi: 10.1111/bcp.13007. Epub 2016 Jun 3.","pmid":"27161955","type":"DERIVED"}],"start_date":{"date":"2015-03"},"study_type":"INTERVENTIONAL","title":"Safety, Feasibility and Cost-effectiveness of Genotype-directed Individualized Dosing of Fluoropyrimidines","url":"https://clinicaltrials.gov/study/NCT02324452"},"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/nct02324452"}