{"preliminary_commentary":{"by_channel":{"x_thread":28,"podcast":5,"youtube":1},"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":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT02562716\", \"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."},"commentary_summary":null,"drugs_tested":[["mFOLFIRINOX"],["gemcitabine","nab-paclitaxel"]],"indication":"resectable pancreatic adenocarcinoma","name":"SWOG S1505","nct_id":"NCT02562716","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=swog-s1505-nct02562716. 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":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive 5-fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity.","label":"Arm I (mFOLFIRINOX, surgery)","type":"EXPERIMENTAL"},{"description":"Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment in the absence of disease progression or unacceptable toxicity.","label":"Arm II (gemcitabine, nab-paclitaxel, and surgery)","type":"EXPERIMENTAL"}],"collaborators":["National Cancer Institute (NCI)"],"completion_date":{"date":"2022-09-26","type":"ACTUAL"},"conditions":["Pancreatic Adenocarcinoma","Resectable Pancreatic Carcinoma"],"enrollment":{"count":147,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Fluorouracil","otherNames":["5-Fluoro-2,4(1H, 3H)-pyrimidinedione","5-Fluorouracil","5-Fluracil","5-FU","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","Gemzar","LY-188011"],"type":"DRUG"},{"name":"Irinotecan Hydrochloride","otherNames":["Campto","Camptosar","Camptothecin 11","Camptothecin-11","CPT 11","CPT-11","Irinomedac","U-101440E"],"type":"DRUG"},{"name":"Oxaliplatin","otherNames":["1-OHP","Ai Heng","Aiheng","Dacotin","Dacplat","Diaminocyclohexane Oxalatoplatinum","Eloxatin","Eloxatine","JM-83","Oxalatoplatin","Oxalatoplatinum","RP 54780","RP-54780","SR-96669"],"type":"DRUG"},{"name":"Paclitaxel Albumin-Stabilized Nanoparticle Formulation","otherNames":["ABI 007","ABI-007","Abraxane","Albumin-bound Paclitaxel","Albumin-Stabilized Nanoparticle Paclitaxel","nab-paclitaxel","Nanoparticle Albumin-bound Paclitaxel","Nanoparticle Paclitaxel","protein-bound paclitaxel"],"type":"DRUG"},{"name":"Pancreatectomy","otherNames":["Excision of the Pancreas","Pancreas Excision"],"type":"PROCEDURE"}],"last_update":"2022-10-19","lead_sponsor":"SWOG Cancer Research Network","official_title":"A Randomized Phase II Study of Perioperative mFOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel as Therapy for Resectable Pancreatic Adenocarcinoma","overall_status":"COMPLETED","phases":["PHASE2"],"primary_completion_date":{"date":"2020-05-31","type":"ACTUAL"},"primary_outcomes":[{"measure":"Overall Survival (OS)","timeFrame":"Up to 4 years for the estimates of median overall survival. Up to 2 years for Statistical Analysis 1 and 2, comparing the observed 2-year overall survival (OS) to the null hypothesis of 40%, in each arm."}],"references":[{"citation":"Sohal DPS, Boutin RD, Lenchik L, Kim J, Beg MS, Wang-Gillam A, Wade JL 3rd, Guthrie KA, Chiorean EG, Ahmad SA, Lowy AM, Philip PA, Chang VT. Body composition measurements and clinical outcomes in patients with resectable pancreatic adenocarcinoma - analysis from SWOG S1505. J Gastrointest Surg. 2024 Mar;28(3):232-235. doi: 10.1016/j.gassur.2023.12.022. Epub 2024 Jan 19.","pmid":"38445914","type":"DERIVED"},{"citation":"Sohal DPS, Duong M, Ahmad SA, Gandhi NS, Beg MS, Wang-Gillam A, Wade JL 3rd, Chiorean EG, Guthrie KA, Lowy AM, Philip PA, Hochster HS. Efficacy of Perioperative Chemotherapy for Resectable Pancreatic Adenocarcinoma: A Phase 2 Randomized Clinical Trial. JAMA Oncol. 2021 Mar 1;7(3):421-427. doi: 10.1001/jamaoncol.2020.7328.","pmid":"33475684","type":"DERIVED"},{"citation":"Ahmad SA, Duong M, Sohal DPS, Gandhi NS, Beg MS, Wang-Gillam A, Wade JL 3rd, Chiorean EG, Guthrie KA, Lowy AM, Philip PA, Hochster HS. Surgical Outcome Results From SWOG S1505: A Randomized Clinical Trial of mFOLFIRINOX Versus Gemcitabine/Nab-paclitaxel for Perioperative Treatment of Resectable Pancreatic Ductal Adenocarcinoma. Ann Surg. 2020 Sep 1;272(3):481-486. doi: 10.1097/SLA.0000000000004155.","pmid":"32740235","type":"DERIVED"}],"start_date":{"date":"2016-01-06","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"S1505: Combination Chemotherapy or Gemcitabine Hydrochloride and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery","url":"https://clinicaltrials.gov/study/NCT02562716"},"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/swog-s1505-nct02562716"}