{"preliminary_commentary":{"by_channel":{"x_thread":5,"podcast":3,"youtube":2},"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\": \"NCT00003389\", \"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,"name":"E2496","nct_id":"NCT00003389","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=e2496-nct00003389. 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":null,"arms":[{"description":"Arm A (ABVD): Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.","label":"Arm A (ABVD)","type":"EXPERIMENTAL"},{"description":"Arm B (Stanford V): Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide \\[375 mg/m²\\] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.","label":"Arm B (Stanford V)","type":"ACTIVE_COMPARATOR"}],"collaborators":["National Cancer Institute (NCI)"],"completion_date":{"date":"2016-05","type":"ACTUAL"},"conditions":["Lymphoma"],"enrollment":{"count":854,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Doxorubicin","otherNames":["Adriamycin","Rubex","Adriamycin RDF","Adriamycin PFS","hydroxydaunorubicin","hydroxydaunomycin","ADR"],"type":"DRUG"},{"name":"Bleomycin","otherNames":["Blenoxane","BLM","Bleo"],"type":"DRUG"},{"name":"Vinblastine","otherNames":["Velban","vinblastine sulfate","vincaleukoblastine","VLB","Velsar","Alkaban AQ"],"type":"DRUG"},{"name":"Dacarbazine","otherNames":["DTIC","DTIC-Dome","DIC","imidazole carboxamide","dimethyl triazeno imidazole carboxamide"],"type":"DRUG"},{"name":"Vincristine","otherNames":["Oncovin","Vincasar PFS","vincristine sulfate","VCR","leurocristine","LCR"],"type":"DRUG"},{"name":"Mechlorethamine","otherNames":["Mustargen","nitrogen mustard"],"type":"DRUG"},{"name":"Etoposide","otherNames":["VP-16","VePesid","VP-16-213","EPEG","epipodophyllotoxin"],"type":"DRUG"},{"name":"Prednisone","otherNames":["Deltasone","Orasone","Medicorten","Panasol-S","Liquid-Pred"],"type":"DRUG"},{"name":"Cyclophosphamide","otherNames":["Cytoxan","Neosar","CTX","CPM"],"type":"DRUG"},{"name":"Radiotherapy","otherNames":[],"type":"RADIATION"}],"last_update":"2023-06-29","lead_sponsor":"Eastern Cooperative Oncology Group","official_title":"A Randomized Phase III Trial of ABVD Versus Stanford V (+/-) Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2011-09","type":"ACTUAL"},"primary_outcomes":[{"measure":"Failure-free Survival at 5 Years","timeFrame":"Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5"}],"references":[{"citation":"Gordon LI, Hong F, Fisher RI, Bartlett NL, Connors JM, Gascoyne RD, Wagner H, Stiff PJ, Cheson BD, Gospodarowicz M, Advani R, Kahl BS, Friedberg JW, Blum KA, Habermann TM, Tuscano JM, Hoppe RT, Horning SJ. Randomized phase III trial of ABVD versus Stanford V with or without radiation therapy in locally extensive and advanced-stage Hodgkin lymphoma: an intergroup study coordinated by the Eastern Cooperative Oncology Group (E2496). J Clin Oncol. 2013 Feb 20;31(6):684-91. doi: 10.1200/JCO.2012.43.4803. Epub 2012 Nov 26.","pmid":"23182987","type":"RESULT"},{"citation":"Advani RH, Hong F, Fisher RI, Bartlett NL, Robinson KS, Gascoyne RD, Wagner H Jr, Stiff PJ, Cheson BD, Stewart DA, Gordon LI, Kahl BS, Friedberg JW, Blum KA, Habermann TM, Tuscano JM, Hoppe RT, Horning SJ. Randomized Phase III Trial Comparing ABVD Plus Radiotherapy With the Stanford V Regimen in Patients With Stages I or II Locally Extensive, Bulky Mediastinal Hodgkin Lymphoma: A Subset Analysis of the North American Intergroup E2496 Trial. J Clin Oncol. 2015 Jun 10;33(17):1936-42. doi: 10.1200/JCO.2014.57.8138. Epub 2015 Apr 20.","pmid":"25897153","type":"DERIVED"},{"citation":"Kanakry JA, Li H, Gellert LL, Lemas MV, Hsieh WS, Hong F, Tan KL, Gascoyne RD, Gordon LI, Fisher RI, Bartlett NL, Stiff P, Cheson BD, Advani R, Miller TP, Kahl BS, Horning SJ, Ambinder RF. Plasma Epstein-Barr virus DNA predicts outcome in advanced Hodgkin lymphoma: correlative analysis from a large North American cooperative group trial. Blood. 2013 May 2;121(18):3547-53. doi: 10.1182/blood-2012-09-454694. Epub 2013 Feb 5.","pmid":"23386127","type":"DERIVED"},{"citation":"Evens AM, Hong F, Gordon LI, Fisher RI, Bartlett NL, Connors JM, Gascoyne RD, Wagner H, Gospodarowicz M, Cheson BD, Stiff PJ, Advani R, Miller TP, Hoppe RT, Kahl BS, Horning SJ. The efficacy and tolerability of adriamycin, bleomycin, vinblastine, dacarbazine and Stanford V in older Hodgkin lymphoma patients: a comprehensive analysis from the North American intergroup trial E2496. Br J Haematol. 2013 Apr;161(1):76-86. doi: 10.1111/bjh.12222. Epub 2013 Jan 29.","pmid":"23356491","type":"DERIVED"}],"start_date":{"date":"1999-06-17","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma","url":"https://clinicaltrials.gov/study/NCT00003389"},"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/e2496-nct00003389"}