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Sponsors and Collaborators: |
University of Leipzig Merck Sanofi-Aventis |
---|---|
Information provided by: | University of Leipzig |
ClinicalTrials.gov Identifier: | NCT00508664 |
The DeLOS II trial is a multicenter randomised phase II trial investigating a TPF-chemotherapy with or without cetuximab for Patients with only by laryngectomy operable carcinoma of the larynx/hypopharynx. Patients were divided in responder or non-responder after 4 weeks. Responder receive TPF with or without Cetuximab + radiation.Planned accrual is 85 patients per treatment arm. The primary study endpoint is a confirmatory proof of an adequate survival rate with a functionally larynx-conserving 2 years after randomisation.
Condition | Intervention | Phase |
---|---|---|
Squamous Cell Carcinoma of the Hypopharynx Larynx Carcinoma |
Radiation: Radiation Drug: Cetuximab Drug: Docetaxel Drug: Cisplatin Drug: 5-Fluorouracil |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | Randomised Phase II Screening Study to be Used in an TPF-Chemotherapy (Short Induction) Before TPF-Induction, Radiotherapy With or Without Cetuximab in the Primary Therapy of the Only by Laryngectomy Operable Carcinoma of the Larynx/Hypopharynx. |
Estimated Enrollment: | 170 |
Study Start Date: | July 2007 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: No Intervention
TPF+Radiation
|
Radiation: Radiation
radiation start in week 11
Drug: Docetaxel
75 mg/m2 i.v. day 1 3 times
Drug: Cisplatin
75 mg/m2 i.v. day 1 3 times
Drug: 5-Fluorouracil
750 mg/m2 i.v. day 1-5 3 times
|
B: Experimental
TPF+Cetuximab+Radiation
|
Radiation: Radiation
radiation start in week 11
Drug: Cetuximab
Day 1 400mg/m2 i.v. than weekly 250 mg/m2 i.v. for 16 weeks
Drug: Docetaxel
75 mg/m2 i.v. day 1 3 times
Drug: Cisplatin
75 mg/m2 i.v. day 1 3 times
Drug: 5-Fluorouracil
750 mg/m2 i.v. day 1-5 3 times
|
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
N-status: cervical metastases (N0-N3) have to be rehabilitate by surgical procedures
electrolytes at NL
Exclusion Criteria:
Contact: Andreas Dietz, Dr. med. | 49-341-972-1700 | andreas.dietz@medizin.uni-leipzig.de |
Austria | |
Landeskrankenhaus Klagenfurt | Not yet recruiting |
Klagenfurt, Austria, A-9020 | |
Contact: Hans Eckel, Prof. Dr. med. | |
Principal Investigator: Hans Edmund, Prof. Dr. med. | |
Germany | |
Klinikum Neukölln, Vivantes GmbH | Not yet recruiting |
Berlin, Germany, 12351 | |
Contact: Volker Schilling, Dr. med. | |
Contact: Petra Feyer, Prof. Dr. med. | |
Principal Investigator: Volker Schilling, Dr. med. | |
Heinrich-Heine-Universität | Not yet recruiting |
Düsseldorf, Germany, 40225 | |
Contact: Henning August Bier, Prof. Dr. med | |
Principal Investigator: Henning August Bier, Prof. Dr. med | |
Klinikum Großhadern | Not yet recruiting |
München, Germany, 81377 | |
Contact: Uli Harreus, Dr. med. | |
Principal Investigator: Uli Harreus, Dr. med. | |
Medizinische Hochschule Hannover | Not yet recruiting |
Hannover, Germany, 30625 | |
Contact: Martin Stieve, Dr. med. | |
Principal Investigator: Martin Stieve, Dr. med. | |
St. Vincentius Kliniken Karlsruhe | Recruiting |
Karlsruhe, Germany, 76135 | |
Contact: Bernard Vanlesow, Dr. med. | |
Principal Investigator: Bernard Vanselow, Dr. med. | |
Klinikum Kassel GmbH | Not yet recruiting |
Kassel, Germany, 34125 | |
Contact: Michael Schröder, Prof. Dr. med | |
Principal Investigator: Michael Schröder, Prof. Dr. med. | |
Phillipps Universität Marburg | Not yet recruiting |
Marburg, Germany, 35037 | |
Contact: Jochen Alfred Werner, Prof. Dr. med. | |
Principal Investigator: Jochen Alfred Werner, Prof. Dr. med. | |
Klinikum Oldenburg gGmbH | Not yet recruiting |
Oldenburg, Germany, 26133 | |
Contact: Florian Hoppe, Prof. Dr. med. | |
Principal Investigator: Florian Hoppe, Prof. Dr. med. | |
Medizinische Fakultät der Westfälischen Wilhelms-Universität Münster | Not yet recruiting |
Münster, Germany, 48149 | |
Contact: Claudia Rudack, Prof. Dr. med. | |
Principal Investigator: Claudia Rudack, Prof. Dr. med. | |
Universitätsklinikum Jena | Recruiting |
Jena, Germany, 07743 | |
Contact: Orlando Guntinas-Lichius, Prof. Dr. med. | |
Principal Investigator: Orlando Guntinas-Lichius, Prof. Dr. med. | |
Universitätsklinik Aachen | Not yet recruiting |
Aachen, Germany, 52074 | |
Contact: Yue-Shih Chen, Dr. med. | |
Principal Investigator: Yue-Shih Chen, Dr. med. | |
Universitätsklinikum Heidelberg | Not yet recruiting |
Heidelberg, Germany, 69120 | |
Contact: Peter Plinkert, Prof. Dr. med. | |
Principal Investigator: Peter Plinkert, Prof. Dr. med. | |
Universitätsklinik Erlangen | Not yet recruiting |
Erlangen, Germany, 91054 | |
Contact: Heinrich Iro, Prof. Dr. med. | |
Principal Investigator: Heinrich Iro, Prof. Dr. med. | |
Universitätsklinik Köln | Not yet recruiting |
Köln, Germany, 50924 | |
Contact: Jens Peter Klussmann, Dr. med. | |
Principal Investigator: Jens Peter Klussmann, Dr. med. | |
Klinikum Ernst von Bergmann gGmbH | Recruiting |
Potsdam, Germany, 14467 | |
Contact: Georg Maschmeyer, Prof. Dr. med. | |
Principal Investigator: Georg Maschmeyer, Prof. Dr. med. | |
Charité, Campus Benjamin Franklin | Not yet recruiting |
Berlin, Germany, 12200 | |
Contact: Ulrich Keilholz, Prof. Dr. med. | |
Principal Investigator: Ulrich Keilholz, Prof. Dr. med. | |
Bayerischen Julius Maximillians-Universtät Würzburg | Not yet recruiting |
Würzburg, Germany, 97080 | |
Contact: Rudolph Hagen, Prof. Dr. med. |
Study Director: | Andreas Dietz, Dr. med. | University of Leipzig |
Responsible Party: | University of Leipzig ( Prof. Andreas Dietz ) |
Study ID Numbers: | TPF+Radiation+/-Cetuximab |
Study First Received: | July 27, 2007 |
Last Updated: | May 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00508664 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
by laryngectomy operable carcinoma of the larynx and the hypopharynx |
Otorhinolaryngologic Neoplasms Otorhinolaryngologic Diseases Squamous cell carcinoma Cetuximab Pharyngeal Neoplasms Pharyngeal Diseases Carcinoma Docetaxel Epidermoid carcinoma Hypopharyngeal Neoplasms |
Cisplatin Fluorouracil Head and Neck Neoplasms Carcinoma, squamous cell Laryngeal carcinoma Hypopharyngeal cancer Neoplasms, Squamous Cell Stomatognathic Diseases Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site Neoplasms by Histologic Type Immunologic Factors |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |