{"commentary":{"count":47,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":39,"youtube":3,"podcast":3,"x_video":2},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT01013649\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"NCT01013649","nct_id":"NCT01013649","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct01013649. The price is fixed at order. We build the report after 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: 41+ commentary sources"},"registry":{"acronym":null,"arms":[{"description":"Patients receive either gemcitabine hydrochloride or allowable combination chemotherapy per standard of care for 5 months. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.","label":"Arm I (gemcitabine hydrochloride or combination chemotherapy)","type":"ACTIVE_COMPARATOR"},{"description":"Patients receive gemcitabine hydrochloride IV over 30 minutes once a week for 3 weeks then off 1 week and erlotinib hydrochloride PO once daily on days 1-28. Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline. (closed to accrual 4/2/14)","label":"Arm II (gemcitabine hydrochloride, erlotinib hydrochloride)","type":"EXPERIMENTAL"},{"description":"Patients receive the same treatment as in arm I for 1 month. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.","label":"Arm III (chemotherapy)","type":"EXPERIMENTAL"},{"description":"Patients receive the same treatment as in arm I for 1 month. Beginning within 7-21 days after completion of chemotherapy, patients undergo radiotherapy (3-dimensional conformal radiotherapy or intensity-modulated radiotherapy) 5 days per week for 5.5 weeks (28 fractions). During radiotherapy, patients receive either capecitabine PO BID 5 days per week or fluorouracil IV continuously for 5.5 weeks or until radiotherapy is completed. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.","label":"Arm IV (chemotherapy, chemoradiotherapy)","type":"EXPERIMENTAL"}],"collaborators":["NRG Oncology"],"completion_date":{"date":"2025-09-04","type":"ACTUAL"},"conditions":["Pancreatic Adenocarcinoma","Pancreatic Ductal Adenocarcinoma","Pancreatic Intraductal Papillary-Mucinous Neoplasm","Stage I Pancreatic Cancer AJCC v6 and v7","Stage II Pancreatic Cancer AJCC v6 and v7"],"enrollment":{"count":546,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"3-Dimensional Conformal Radiation Therapy","type":"RADIATION"},{"name":"Biospecimen Collection","type":"PROCEDURE"},{"name":"Capecitabine","type":"DRUG"},{"name":"Chemotherapy","type":"DRUG"},{"name":"Computed Tomography","type":"PROCEDURE"},{"name":"Erlotinib Hydrochloride","type":"DRUG"},{"name":"Fluorouracil","type":"DRUG"},{"name":"Gemcitabine Hydrochloride","type":"DRUG"},{"name":"Intensity-Modulated Radiation Therapy","type":"RADIATION"},{"name":"Magnetic Resonance Imaging","type":"PROCEDURE"},{"name":"Quality-of-Life Assessment","type":"OTHER"},{"name":"X-Ray Imaging","type":"PROCEDURE"}],"last_update":"2026-02-23","lead_sponsor":"National Cancer Institute (NCI)","official_title":"A Phase II-R and a Phase III Trial Evaluating Both Erlotinib (Ph II-R) and Chemoradiation (Ph III) as Adjuvant Treatment for Patients With Resected Head of Pancreas Adenocarcinoma","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2023-12-10","type":"ACTUAL"},"primary_outcomes":[{"measure":"Overall Survival (Percentage of Participants Alive) [Phase II]","timeFrame":"From step 1 randomization (gemcitabine vs. gemcitabine/erlotinib) to death or last follow-up. 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Epub 2026 Jun 9.","pmid":"42456089","type":"DERIVED"},{"citation":"Jethwa KR, Kim E, Berlin J, Anker CJ, Tchelebi L, Abood G, Hallemeier CL, Jabbour S, Kennedy T, Kumar R, Lee P, Sharma N, Small W Jr, Williams V, Russo S. Executive Summary of the American Radium Society Appropriate Use Criteria for Neoadjuvant Therapy for Nonmetastatic Pancreatic Adenocarcinoma: Systematic Review and Guidelines. Am J Clin Oncol. 2024 Apr 1;47(4):185-199. doi: 10.1097/COC.0000000000001076. Epub 2023 Dec 22.","pmid":"38131628","type":"DERIVED"},{"citation":"Tchelebi LT, Winter KA, Abrams RA, Safran HP, Regine WF, McNulty S, Wu A, Du KL, Seaward SA, Bian SX, Aljumaily R, Shivnani A, Knoble JL, Crocenzi TS, DiPetrillo TA, Roof KS, Crane CH, Goodman KA. Analysis of Radiation Therapy Quality Assurance in NRG Oncology RTOG 0848. Int J Radiat Oncol Biol Phys. 2024 Jan 1;118(1):107-114. doi: 10.1016/j.ijrobp.2023.08.014. Epub 2023 Aug 19.","pmid":"37598723","type":"DERIVED"},{"citation":"Conroy T, Lambert A, Ducreux M. Adjuvant and neoadjuvant approaches in pancreatic cancer. Curr Opin Oncol. 2023 Jul 1;35(4):326-333. doi: 10.1097/CCO.0000000000000962. Epub 2023 May 12.","pmid":"37222189","type":"DERIVED"},{"citation":"Batukbhai B, Herman JM, Zahurak M, Laheru DA, Le DT, Wolfgang CL, Zheng L, De Jesus-Acosta A. Survival Outcomes of Adjuvant Chemotherapy Combined With Radiation Versus Chemotherapy Alone After Pancreatectomy for Distal Pancreatic Adenocarcinoma: A Single-Institution Experience. Pancreas. 2021 Jan 1;50(1):64-70. doi: 10.1097/MPA.0000000000001724.","pmid":"33370024","type":"DERIVED"}],"start_date":{"date":"2010-04-05","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Gemcitabine Hydrochloride With or Without Erlotinib Hydrochloride Followed by the Same Chemotherapy Regimen With or Without Radiation Therapy and Capecitabine or Fluorouracil in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery","url":"https://clinicaltrials.gov/study/NCT01013649"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct01013649"}