Publikationen

Beteiligung von KKS-MitarbeiterInnen an Publikationen der betreuten Studien

Journalbeiträge  

• Schmoll HJ, Mann J, Meinert F, Garlipp B, Borchert K, Vogel A, Goekkurt E, Kaiser U, Hoeffkes HG, Rüssel J, Kanzler S, Edelmann T, Forstbauer H, Göhler T, Hannig C, Hildebrandt B, Roll C, Bokemeyer C, Steighardt J, Cygon F, Ibach S, Stein A, Tintelnot J. Efficacy and quality of life for FOLFOX/bevacizumab +/- irinotecan in first-line metastatic colorectal cancer-final results of the AIO CHARTA trial. Br J Cancer 2024, 130(2):233-241
• Plontke SK, Girndt M, Meisner C, Fischer I, Böselt I, Löhler J, Ludwig-Kraus B, Richter M, Steighardt J, Reuter B, Böttcher C, Langer J, Pethe W, Seiwerth I, Jovanovic N, Großmann W, Kienle-Gogolok A, Boehm A, Neudert M, Diensthuber M, Müller A, Dazert S, Guntinas-Lichius O, Hornung J, Vielsmeier V, Stadler J, Rahne T for the HODOKORT Trial Investigators. High Dose Glucocorticoids for the Treatment of Sudden Hearing Loss.  NEJM Evid 2024, 3(1). doi: 10.1056/EVIDoa2300172
• Ripoll C, Platzer S, Franken P, Aschenbach R, Wienke A, Schuhmacher U, Teichgräber U, Stallmach A, Steighardt J, Zipprich A, Liver-HERO Study Group. Liver-HERO: hepatorenal syndrome-acute kidney injury (HRS-AKI) treatment with transjugular intrahepatic portosystemic shunt in patients with cirrhosis - a randomized controlled trial. Trials 2023, 24(1):258
• Tchirikov M, Haiduk C, Tchirikov M, Riemer M, Bergner M, Li W, Henschen S, Entezami M, Wienke A, Seliger G. Treatment of Classic Mid-Trimester Preterm Premature Rupture of Membranes (PPROM) with Oligo/Anhydramnion between 22 and 26 Weeks of Gestation by Means of Continuous Amnioinfusion: Protocol of a Randomized Multicentric Prospective Controlled TRIAL and Review of the Literature. Life 2022, 12(9):1351  
• Plontke SK, Girndt M, Meisner C, Böselt I, Ludwig-Kraus B, Richter M, Rahne T. Efficacy and safety of systemic, high-dose glucocorticoid therapy for idiopathic sudden sensorineural hearing loss : Study protocol for a three-armed, randomized, triple-blind, multicenter trial (HODOKORT). HNO. 2022, 70(Suppl 2):30-44  
• Theil G, Richter M, Schulze M, Köttig T, Patz B, Heim S, Krauß Y, Markov M, Fornara P. Extract from Cucurbita pepo improves BPH symptoms without affecting sexual function: a 24-month noninterventional study. World J Urol. 2022, 40(7):1769-1775
• Krug S, Kegel T, Gress TM, Rinke A, Apostolidis L, Jann H, König A, Hörsch D, Schrader J, Ettrich TJ, Richter M, Steighardt J, Michl P: Ramucirumab in combination with dacarbazine in patients with progressive well-differentiated metastatic pancreatic neuroendocrine tumors (RamuNET): study protocol for a  multicenter single-arm trial. BMC Cancer 2021, 21(1):1206    
• Wittlinger T, Schwaab B, Völler H, Bongarth C, Heinze V, Eckrich K, Guha M, Richter M,  Schlitt A. Efficacy of lipid-lowering therapy during cardiac rehabilitation in patients with diabetes mellitus and coronary heart disease. J. Cardiovasc. Dev. Dis. 2021, 8: 105
• Scheller C, Strauss C, Leisz S, Hänel P, Klemm A, Kowoll S, Böselt I, Rahne T, Wienke A. Prophylactic nimodipine treatment for hearing preservation after vestibular schwannoma surgery: study protocol of a randomized multi-center phase III trial-AkniPro 2. Trials 2021, 22(1):475
• Schmoll HJ, Lindner L, Reichardt P, Heißner K, Kopp HG, Kessler T, Mayer-Steinacker R, Rüssel J, Egerer G, Crysandt M, Kasper B, Niederwieser D, Kunitz A, Eigendorff E,  Petersen I, Steighardt J, Cygon F, Meinert F, Stein A: Pazopanib with or without gemcitabine in antracycline and / or ifosfamide refractory soft tissue sarcoma. Final results of the randomized phase II PAPAGEMO trial. JAMA Oncol. 2021, 7(2):255-262
• Schmoll HJ, Stein A, Van Cutsem E, Price T, Hofheinz RD, Nordlinger B, Daisne JF, Janssens J, Brenner B, Reinel H, Hollerbach S, Caca K, Fauth F, Hannig CV, Zalcberg J, Tebbutt N, Mauer ME, Marreaud S, Lutz MP, Haustermans K: Pre- and Postoperative Capecitabine Without or With Oxaliplatin in Locally Advanced Rectal Cancer: PETACC 6 Trial by EORTC GITCG and ROG, AIO, AGITG, BGDO, and FFCD. J Clin Oncol. 2021, 39(1):17-29      

2011 -2020

• Ayerle GM, Schäfers R, Mattern E, Striebich S, Haastert B, Vomhof M, Icks A, Ronniger Y, Seliger G. Study Protocol: Effects of the birthing room environment on vaginal births and client-centred outcomes for women at term planning a vaginal birth: BE-UP, a multicentre randomised controlled trial. Trials 2018, 19: 641
• Nuding S, Schröder J, Presek P, Wienke A, Müller-Werdan U, Ebelt H, Werdan K. Reducing elevated heart rates in patients with multiple organ dysfunction syndrome with the If (Funny Channel Current) inhibitor ivabradine. Shock 2018 Apr;49(4): 402-411
• Scheller C, Wienke A, Tatagiba M, Gharabaghi A, Ramina KF, Ganslandt O, Bischoff B, Zenk J, Engelhorn T, Matthies C, Westermaier T, Antoniadis G, Pedro M, Rohde V, von Eckardstein K, Kretschmer K, Kornhuber M, Steighardt J, Richter M, Barker FG, Strauss C. Prophylactic nimodipine treatment improves hearing outcome after vestibular schwannoma surgery: a combined analysis of a randomized, multicenter, phase III trial and its pilot-study. J Neurosurg 2017, 127(6): 1376-1383
• Löhler J, Akcicek B, Dreier G, Werner J, Steighardt J, Rahne T, Plontke S. Voraussetzungen an eine Studien-Praxis am Beispiel der HODOKORT-Studie. HNO-Mitteilungen 2016, 2:67-69
• Wieczorrek G, Weber U, Wienke A, Egner E, Schröder J, Vogt A, Müller-Werdan U, Weber A, Steighardt J, Girschick C, Schlitt A. Adherence to phase III cardiac rehabilitation programs: a prospective, randomized comparison between a conventionally conducted program and a Tai Chi based program. Sportverletz Sportschaden 2016, 30(2): 95-100
• Plontke SK, Girndt M, Meisner C, Probst R, Oerlecke I, Richter M, Steighardt J, Dreier G, Weber A, Baumann I, Plößl S, Löhler J, Laszig R,  Werner JA, Rahne T. Multizentrische Studie zur Hörsturztherapie – Planung und Konzeption. HNO 2016, 64(4): 227-36.
• Scheller C, Wienke A, Tatagiba M, Gharabaghi A, Ramina K, Ganslandt O, Bischoff B, Zenk J, Engelhorn T, Matthies C, Westermaier T, Antoniadis G, Pedro M, Rohde V, von Eckardstein K, Kretschmer K, Kornhuber M, Steighardt J, Richter M, Barker F, Strauss C. Prophylactic nimodipine treatment for cochlear and facial nerve preservation after vestibular schwannoma surgery: a randomized multicenter phase III trial. J Neurosurg 2016, 124(3): 657-64 
• Dellas K , Buller J, Görtz GJ, Richter M, Höhler T, Arnold D, Keck T, Dunst J, Zühlke H. Analysis of Bevacizumab-based Preoperative Radiochemotherapy in Patients with Locally Advanced Rectal Cancer on Surgery-associated Spectrum of Complications. Ann Surg Oncol 2014, 21: 1352-60
• Stein A, Arnold D, Thuss-Patience PC, Moehler M, Grothe W, Seufferlein T, Reinacher-Schick A, Geissler M, Hofheinz RD, Schmoll HJ. Docetaxel, oxaliplatin and capecitabine (TEX regimen) in patients with metastatic gastric or gastro-esophageal cancer: results of a multicenter phase I/II study. Acta Oncol 2014, 53: 392-398
• Dellas K, Höhler T, Reese T, Würschmidt F, Engel E, Rödel C, Wagner W, Richter M, Arnold D, Dunst J. Phase II trial of preoperative radiochemotherapy with concurrent bevacizumab, capecitabine and oxaliplatin in patients with locally advanced rectal cancer. Radiat Oncol 2013, 8: 90
• Steighardt J, Wolff S. Wie ein Patient in eine klinische Studie gelangt. Medialog 2/2012, 20-21.
• Fiedler R, Neugebauer F, Ulrich C, Wienke A, Gromann C, Storr M, Böhler T, Seibert E, Girndt M. Randomized controlled pilot study of 2weeks' treatment with high cutoff membrane for hemodialysis patients with elevated C-reactive protein. Artif Organs 2012, 36: 886-893.
• Dellas K, Reese T, Richter M, Arnold D, Dunst J. Concurrent chemoradiation of metastases with capecitabine and oxaliplatin and 3D-CRT in patients with oligometastatic colorectal cancer: results of a phase I study. Radiat Oncol 2012, 7: 83.
• Stein A, Glockzin G, Wienke A, Arnold D, Edelmann T, Hildebrandt B, Hollerbach S, Illerhaus G, Königsrainer A, Richter M, Schlitt HJ, Schmoll HJ. Treatment with bevacizumab and FOLFOXIRI in patients with advanced colorectal cancer: presentation of two novel trials (CHARTA and PERIMAX) and review of the literature. BMC Cancer 2012, 12:356.
• Soukup J, Selle A, Wienke A, Steighardt J, Wagner NM, Kellner P. Efficiency and safety of inhalative sedation with sevoflurane in comparison to an intravenous sedation concept with propofol in intensive care patients – study protocol for a randomized controlled trial. Trials 2012, 13: 135.
• Prondzinsky R, Unverzagt S, Russ M, Lemm H, Swyter M, Wegener N, Buerke U, Raaz U, Ebelt H, Schlitt A, Heinroth K, Haerting J, Werdan K, Buerke M. The Prospective, Randomised IABP - Shock-Trial - Hemodynamic Effects of Intraaortic Balloon Counterpulsation in Patients With Acute Myocardial Infarction complicated by Cardiogenic Shock. Shock 2012, 37: 378-384.
• Nuding S, Ebelt H, Hoke RS, Krummenerl A, Wienke A, Müller-Werdan U, Werdan K. Reducing elevated heart rate in patients with multiple organ dysfunction syndrome by the I (f) (funny channel current) inhibitor ivabradine : MODI (f)Y Trial. Clin Res Cardiol 2011, 100: 915-23.

2003 - 2010

• Gaul C, Malcherczyk A, Schmidt T, Helm J, Haerting J. Bereitschaft von Patienten zum Einschluss in klinische Studien. Z Med Klin (Munich) 2010, 105: 73-79.
• Wagner AD, Buechner-Steudel P, Moehler M, Schmalenberg H, Behrens R, Fahlke J, Wein A, Behl S, Kuss O, Kleber G, Fleig WE.Gemcitabine, oxaliplatin and 5-FU in advanced bile duct and gallbladder carcinoma: two parallel, multicentre phase-II trials. Br J Cancer 2009,101:1846-52.
• Albert JG, Kotsch J, Köstler W, Behl S, Kaltz B, Bokemeyer B, Dollinger MM, Haerting J, Fleig WE. Course of Crohn's disease prior to establishment of the diagnosis. Z Gastroenterol 2008, 46: 187-92.
• Scheele JS, Steighardt J, Brosteanu O, Hoyer H. Übernahme der Sponsorfunktion in wissenschaftsinitiierten klinischen Prüfungen durch Universitäten oder andere akademische Institutionen. Klinische Forschung und Recht 2007, 2: 33-39.
• Kuchinke W, Freudigmann M, Häber A, Sax U, Kotsch J, Semler SC: Elektronische Archivierung als strategische Aufgabe - Bedarfsanalyse und Problemfelder in der klinischen Forschung; in: Telemedizinführer 2008, Hrsg: Jäckel A; Bad Nauheim, 2007, S. 25 – 33.
• Gaul C, Schmidt T, Helm J, Hoyer H, Haerting J. Motivation and barriers to participation in clinical trials. Med Klin (Munich) 2006, 101: 873-879.
• Heinroth KM, Stabenow I, Moldenhauer I, Unverzagt S, Buerke M, Werdan K, Prondzinsky R. Temporary trans-coronary pacing by coated guidewires: a safe and reliable method during percutaneous coronary intervention. Clin Res Cardiol. 2006, 95: 206-11
• Kuss O, Gromann C, Diepgen TL. Model-based clustering of binary longitudinal atopic dermatitis disease histories by latent class mixture models. Biom J 2006, 48:105-16.
• Wagner AD, Grothe W, Haerting J, Kleber G, Grothey A, Fleig WE. Chemotherapy in advanced gastric cancer: a systematic review and meta-analysis based on aggregate data. J Clin Oncol 2006, 24: 2903-2909
• Wagner AD, Grothe W, Behl S, Kleber G, Grothey A, Haerting J, Fleig WE. Chemotherapy for advanced gastric cancer. Cochrane Database Syst Rev 2005 Apr 18 (2):CD004064. Review
• Prondzinsky R, Knüpfer A, Loppnow H, Redling F, Lehmann DW, Stabenow I, Witthaut R, Unverzagt S, Radke J, Zerkowski H-R, Werdan K. Surgical trauma affects the proinflammatory status after cardiac surgery to a higher degree than cardiopulmonary bypass. J Thoracic Cardiovasc Surg 2005, 129: 760-766
• Schmelzle H, Schröder S, Armrust S, Unverzagt S, Fusch C. Resting energy expenditure in obese children aged 4 to 15 years: measured versus predicted data. - Acta Paediatr 2004, 93: 739-746  

Ausgewählte Kongressbeiträge

• Jaramillo Segura S, Wass M, Schaffrath J, Rieger K, Nogai A, Hänel M, Herbst R, Stölzel F, Röllig C, Jost E, Schlenk RF, Noppeney R, Brandts CH, Krug U, Götze KS, Buske S, Florschütz A, Schubert J, Opitz B, Mohren M, Eßeling E, von Witzendorff S, Subklewe M, Kaufmann M, Frickhofen N, Scholz CW, Schäfer-Eckart K, Kunzmann V, Schmidt-Hieber M, Sayer HG, Rank A, Hemmati P, Schüler F, Kowoll S, Scheller M, Steighardt J,  Edemir B, Müller LP, Gliko-Kabir I, Ludwig-Kraus B, Edemir S, Sorani E, Binder M, Vainstein A, Kadosh S, Gromann C, Wienke A, Baldus CD, Platzbecker U, Serve H, Bornhäuser M, Junghanss C, Müller-Tidow C. Double-blind, placebo controlled, randomized, multicenter, phase II study to assess the efficacy of the high affinity CXCR4 inhibitor BL-8040 as addition to consolidation therapy in AML by the ASL and OSHO Leukemia Study Groups. ASH Annual Meeting Dec 2022, New Orleans. Abstract in Blood 2022, 140 Suppl. 1, 3338-3340 
• Schmoll H-J, Meinert FM, Cygon F, Garlipp B, Junghanss C, Leithaeuser M, Vogel A, Schaefers M, Kaiser U,  Hoeffkes H-G, Florschütz A, Rüssel J, Kanzler S, Edelmann T, Forstbauer H, Goehler T, Hannig C, Hildebrandt B, Steighardt J, Stein A. “CHARTA”: FOLFOX/Bevacizumab vs. FOLFOXIRI/Bevacizumab in advanced colorectal cancer - Final results, prognostic and potentially predictive factors from the randomized Phase II trial of the AIO. Abstract #193842, 2017 ASCO Annual Meeting, Chicago (Poster), Abstract in J Clin Oncol 2017, 35, suppl: abstr 3533
• Rüssel J, Lindner L, Reichardt P, Heißner K, Kopp H-G, Kessler T, Mayer-Steinacker R, Egerer G, Crysandt M, Kasper B, Niederwieser D, Kunitz A, Eigendorff E, Steighardt J, Cygon F, Meinert F, Stein A, Schmoll H-J. Pazopanib vs pazopanib / gemcitabine in refractory soft tissue sarcoma: The  AIO-STS-009-trial. DGHO 2016 (Vortrag), Abstract in Oncol Res Treat 2016;39(suppl 3):306
• Wass M, Baldus C, Scholz C, Schäfer-Eckart K, Mohren M, Jakob C, Hänel M, Götze K, Sauer T, Jost E, Noppeney R, Stölzel F, Brandts C, Frickhofen N, Krug U, Kiehl M, Schüler F, Opitz B, Schubert J, Junghanß C, Kunzmann V, Krämer A, Florschütz A, Kowoll S, Steighardt, Wienke A, Richter M, Wickenhauser C, Vainstein-Haras A, Pereg Y, Stepner L, Aharon A, Tschanter P, Müller L, Maschmayer G, Serve H, Berdel W, Niederwieser D, Ehninger G, Müller-Tidow C. The CXCR4 antagonist BL-8040 added to standard consolidation therapy in patients with newly diagnosed AML in first CR: an ongoing multicenter, phase 2, randomized trial. Abstract EHA 2016
• Schlitt A, Wieczorrek G, Girschick C, Egner E, Weber U, Weber A, Steighardt J, Wienke A, Schröder J, Vogt A, Müller-Werdan U. Adhärenz in Herzgruppen – ein prospektiver, randomisierter Vergleich einer konventionell durchgeführten Herzgruppe zu einer Tai-Chi-Herzgruppe. Poster, 42. Jahrestagung Deutsche Gesellschaft für Prävention und Rehabilitation von Herz-Kreislauferkrankungen e. V (DGPR), Berlin 2015
• Classen C, Steighardt J, Wienke A, Rausche U, Kramm C. HIT-HGG-CilMetro – A phase II study using cilengitide and metronomic temozolomide for relapsed or refractory high grade gliomas or diffuse intrinsic pontine gliomas in children and adolescents. Poster, 14th Int. Symp. on Pediatric Neuro-Oncology Wien 2010, Abstract in Neuro-Oncology 2010, 12: ii89
• Arnold D, Thuss-Patience P, Stein A, Grothe W, Seufferlein T, Reinacher-Schick A, Geissler M, Hofheinz R, Moehler M, Schmoll H-J. Docetaxel, Cisplatin and Capecitabine (TEX regimen) in patients with advanced or metastatic gastric or gastroesophageal cancer: A phase II study of the Arbeitsgemeinschaft Internistische Onkologie (AIO). Poster 4099, ASCO Annual Meeting 2010, Chicago
• Kuchinke W, Freudigmann M, Kotsch J, Sax U, Speer R, Wiegelmann S, Semler SC: Elektronische Archivierung klinischer Studiendaten: Ist- und Bedarfsanalyse in klinischen Forschungsnetzwerken. Kongress Medizin und Gesellschaft 2007. Augsburg, 17.-21.09.2007. Online-Publikation dieses Beitrags bei egms.de
• Haerting J. Kursangebote des KKS-Netzwerkes - Perspektiven der Aus- und Fortbildung in patientenorientierter klinischer Forschung. Vortrag auf dem 1. KKS-N-Symposium, Leipzig, 14. 09. 2006 (http://kks-netzwerk.de/media/dokumente/Haerting.ppt)
• Albert JG, Kotsch J, Köstler W, Behl S, Hoyer H, Fleig WE. Analyse des Krankheitsverlaufes bis zur Diagnosestellung bei Patienten mit Morbus Crohn - Konzept einer deutschlandweiten, Internet-basierten Datenerhebung (die "DMC-Online Befragung"), Poster GMDS Leipzig 2006
• Wittenberg M, Speer R, Kuchinke W, Weber R, Antony G, Käppler M, Kotsch J, Meisner C, Müller S, Peters R, Wiegelmann S: Erreichung und Sicherstellung von Validierungsstandards in den Forschungsverbünden der Telematikplattform für Medizinische Forschungsnetze e.V. (TMF), Vortrag und Poster GMDS Leipzig 2006
• Wagner AD, Grothe W, Haerting J, Kleber G, Grothe A, Fleig WE. Chemotherapy in advanced gastric cancer: what is the evidence? Poster ECCO 2005
• Wagner AD, Buechner-Steudel P, Wein A, Masri-Zada R, Schmalenberg H, Kleber G, Kuss O, Moehler M, Behrens R, Fleig WE. Gemcitabine, Oxaliplatin and weekly high-dose 5-FU as a 24-hr-infusions in chemonaive patients with advanced or metastatic pancreatic adenocarcinoma: Preliminary results of a multicenter phase II-study. Proc. Am. Soc. Clin. Oncol. 2004, # 4096