{"preliminary_commentary":{"by_channel":{"bluesky_thread":124},"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":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT01516216\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"name":"NCT01516216","nct_id":"NCT01516216","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct01516216. 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":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"FOLFOX-bevacizumab: intravenously on Day 1 (+/- 7 days) of every two-week cycle per institutional standards + 400 IU vitamin D3 orally once daily\n\nParticipants were treated until disease progression, unacceptable toxicity or withdrawal for other reasons.","label":"Chemotherapy + Standard Dose Vitamin D","type":"ACTIVE_COMPARATOR"},{"description":"FOLFOX-bevacizumab: intravenously on Day 1 (+/- 7 days) of every two-week cycle per institutional standards + 8000 IU daily x 2 weeks as loading dose, followed by 4000 IU daily as maintenance dose.\n\nParticipants were treated until disease progression, unacceptable toxicity or withdrawal for other reasons.","label":"Chemotherapy + Higher Dose","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2019-11-09","type":"ACTUAL"},"conditions":["Metastatic Colorectal Cancer"],"enrollment":{"count":139,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"FOLFOX + bevacizumab","otherNames":["5-FU (5-fluorouracil)","Leucovorin","Oxaliplatin (Eloxatin)","Bevacizumab (Avastin)"],"type":"DRUG"},{"name":"Vitamin D","otherNames":[],"type":"DIETARY_SUPPLEMENT"}],"last_update":"2022-04-26","lead_sponsor":"Dana-Farber Cancer Institute","official_title":"Randomized, Double-Blind, Phase II Trial of Vitamin D Supplementation in Patients With Previously Untreated Metastatic Colorectal Cancer","overall_status":"COMPLETED","phases":["PHASE2"],"primary_completion_date":{"date":"2019-11-09","type":"ACTUAL"},"primary_outcomes":[{"measure":"Median Progression-free Survival (PFS)","timeFrame":"Disease was evaluated every 4 cycles on treatment and off treatment every 8-16 weeks until PD or non-protocol therapy start if discontinued for reason other than PD. Participants were observed up to 28.5 months with maximum follow-up of 56.7 months."}],"references":[{"citation":"Ng K, Nimeiri HS, McCleary NJ, Abrams TA, Yurgelun MB, Cleary JM, Rubinson DA, Schrag D, Miksad R, Bullock AJ, Allen J, Zuckerman D, Chan E, Chan JA, Wolpin BM, Constantine M, Weckstein DJ, Faggen MA, Thomas CA, Kournioti C, Yuan C, Ganser C, Wilkinson B, Mackintosh C, Zheng H, Hollis BW, Meyerhardt JA, Fuchs CS. Effect of High-Dose vs Standard-Dose Vitamin D3 Supplementation on Progression-Free Survival Among Patients With Advanced or Metastatic Colorectal Cancer: The SUNSHINE Randomized Clinical Trial. JAMA. 2019 Apr 9;321(14):1370-1379. doi: 10.1001/jama.2019.2402.","pmid":"30964527","type":"BACKGROUND"}],"start_date":{"date":"2012-04-13","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Vitamin D in Untreated Metastatic Colorectal Cancer","url":"https://clinicaltrials.gov/study/NCT01516216"},"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/nct01516216"}