{"preliminary_commentary":{"by_channel":{"x_thread":5},"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":"SUNLIGHT","nct_id":"NCT04737187","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=sunlight-nct04737187. 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":"SUNLIGHT","arms":[{"description":"Participants were administered 35 milligrams per square meter per dose (mg/m²/dose) trifluridine/tipiracil (FTD/TPI) orally twice a day (BID), within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 an Day 13 to 14), over 2 weeks, followed by a 14-day rest; with bevacizumab (5 milligrams per kilogram \\[mg/kg\\], intravenous \\[IV\\] infusion administered every 2 weeks (Day 1 and Day 15). This treatment cycle was repeated every 4 weeks.","label":"Trifluridine/Tipiracil + Bevacizumab","type":"EXPERIMENTAL"},{"description":"Participants were administered 35 mg/m²/dose of FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest. This treatment cycle was repeated every 4 weeks.","label":"Trifluridine/Tipiracil","type":"ACTIVE_COMPARATOR"}],"collaborators":["Institut de Recherches Internationales Servier"],"completion_date":{"date":"2023-09-12","type":"ACTUAL"},"conditions":["Refractory Metastatic Colorectal Cancer"],"enrollment":{"count":492,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Trifluridine/Tipiracil","otherNames":["TAS102","S 95005","Lonsurf"],"type":"DRUG"},{"name":"Bevacizumab","otherNames":["Avastin"],"type":"DRUG"}],"last_update":"2024-09-24","lead_sponsor":"Taiho Oncology, Inc.","official_title":"An Open-label, Randomized, Phase III Study Comparing Trifluridine/Tipiracil in Combination With Bevacizumab to Trifluridine/Tipiracil Monotherapy in Patients With Refractory Metastatic Colorectal Cancer (SUNLIGHT Study)","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2022-07-19","type":"ACTUAL"},"primary_outcomes":[{"measure":"Overall Survival (OS)","timeFrame":"From date of randomization to the death due to any cause or cut-off date, whichever comes first (maximum duration: up to 20 months)"},{"measure":"Survival Probability at 6 Months","timeFrame":"From date of randomization until 6 months post treatment"},{"measure":"Survival Probability at 12 Months","timeFrame":"From date of randomization until 12 months post treatment"},{"measure":"Survival Probability at 18 Months","timeFrame":"From date of randomization until 18 months post treatment"}],"references":[{"citation":"Prager GW, Taieb J, Fakih M, Ciardiello F, Van Cutsem E, Elez E, Cruz FM, Wyrwicz L, Stroyakovskiy D, Papai Z, Poureau PG, Liposits G, Cremolini C, Bondarenko I, Modest DP, Benhadji KA, Amellal N, Leger C, Vidot L, Tabernero J; SUNLIGHT Investigators. Trifluridine-Tipiracil and Bevacizumab in Refractory Metastatic Colorectal Cancer. N Engl J Med. 2023 May 4;388(18):1657-1667. doi: 10.1056/NEJMoa2214963.","pmid":"37133585","type":"RESULT"},{"citation":"Prager GW, Taieb J, Fakih M, Ciardiello F, Van Cutsem E, Elez E, Wyrwicz L, Stroyakovskiy D, Liposits G, Bondarenko I, Modest DP, Amellal N, Tabernero J; SUNLIGHT Investigators. Plain language summary of SUNLIGHT: trifluridine/tipiracil and bevacizumab for refractory metastatic colorectal cancer. Future Oncol. 2024;20(36):2823-2832. doi: 10.1080/14796694.2024.2366100. Epub 2024 Jul 2.","pmid":"38953855","type":"DERIVED"}],"start_date":{"date":"2020-11-25","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Phase III Study of Trifluridine/Tipiracil With and Without Bevacizumab in Refractory Metastatic Colorectal Cancer Patients","url":"https://clinicaltrials.gov/study/NCT04737187"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/sunlight-nct04737187"}