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a Multicenter Clinical Trial for the Treatment of Children and Adolescents With Soft Tissue Sarcoma Stage 4
This study is currently recruiting participants.
Verified by Cooperative Weichteilsarkom Gruppe, September 2006
Sponsors and Collaborators: Cooperative Weichteilsarkom Gruppe
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by: Cooperative Weichteilsarkom Gruppe
ClinicalTrials.gov Identifier: NCT00130858
  Purpose

Phase II Study to evaluate the response on two blocks of topotecan and carboplatin


Condition Intervention Phase
Sarcoma, Soft Tissue
 Drug: Topotecan
Drug: Carboplatin
 Phase II

MedlinePlus related topics: Soft Tissue Sarcoma
Drug Information available for: Carboplatin Topotecan hydrochloride Topotecan
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title: a Multicenter Clinical Trial for the Treatment of Children and Adolescents With Soft Tissue Sarcoma Stage 4

Further study details as provided by Cooperative Weichteilsarkom Gruppe:

Primary Outcome Measures:
  • Response according to RECIST criteria

Secondary Outcome Measures:
  • Toxicity
  • Overall-Survival
  • Event-free-survival

Estimated Enrollment: 90
Study Start Date: January 2005
Estimated Study Completion Date: December 2007
Detailed Description:

Phase II study for patients with chemosensible soft tissue sarcoma stage IV in children and adolescents ; response according to RECIST criteria following two blocks of combination therapy consisting of Topotecan and carboplatin

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Soft tissue sarcoma chemosensible, stage IV
  • age < 21
  • measurable tumor lesions

Exclusion Criteria:

  • Lack of cooperation by the patient
  • no willingness of follow-up examinations
  • participation on another clinical trial at the same time
  • death due to the sickness within four weeks
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00130858

Contacts
Contact: Thomas Klingebiel, Prof. Dr. (+49) 69 63 01 5094 thomas.klingebiel@kgu.de
Contact: Christoph H. Gleiter, Prof. Dr. (+49) 70 71 29 7 22 61 christoph.gleiter@kks-ukt.de

Locations
Germany
Zentralklinikum Not yet recruiting
Augsburg, Germany, 86156
Contact: Gnekow, Dr.            
Sub-Investigator: Gnekow, Dr.            
Virchow Klinik Not yet recruiting
Berlin, Germany, 13353
Contact: Henze, Prof. Dr.            
Sub-Investigator: Henze, Prof. Dr.            
Zentrum für Kinderheilkunde Not yet recruiting
Bonn, Germany, 53113
Contact: U. Bode, Prof. Dr.            
Sub-Investigator: U. Bode, Prof.Dr.            
Universitäts-Kinderklinik Recruiting
Homburg/saar, Germany, 66421
Contact: N. Graf, Prof. Dr.            
Sub-Investigator: N. Graf, Prof. Dr.            
Universitätsklinik für Kinderund Jugendliche Recruiting
Erlangen, Germany, 91054
Contact: J. D. Beck, Prof. Dr.            
Sub-Investigator: J. D. Beck, Prof. Dr.            
Universitätsklinik und Poliklinik Recruiting
Leipzig, Germany, 04137
Contact: Körholz, Prof. Dr.            
Sub-Investigator: Körholz, Prof. Dr.            
Klinikum der Universität Not yet recruiting
Frankfurt, Germany, 60590
Contact: Thomas Klingebiel, Prof. Dr.     (+49) 69 63 01 5094     thomas.klingenbiel@kgu.de    
Sub-Investigator: Thomas Klingebiel, Prof. Dr.            
Klinikum Berlin-Buch Not yet recruiting
Berlin, Germany, 13125
Contact: W. Dörffel, Dr. med.            
Sub-Investigator: W. Dörffel, Dr. med.            
Zentralkrankenhaus Bremen Not yet recruiting
Bremen, Germany, 28205
Contact: Th. Lieber, Dr. med.            
Sub-Investigator: Th. Lieber, Dr. med.            
Klinik für Kinder- und Jugendmedizin Recruiting
Jena, Germany, 07740
Contact: F. Zintl, Prof. Dr.            
Sub-Investigator: F. Zintl, Prof. Dr.            
Heinrich-Heine-Universität Not yet recruiting
Düsseldorf, Germany, 40001
Contact: Göbel, Prof. Dr.            
Sub-Investigator: Göbel, Prof. Dr.            
Universitätsklinikum Essen Not yet recruiting
Essen, Germany, 45147
Contact: Havers, Prof. Dr.            
Sub-Investigator: Havers, Prof. Dr.            
Universitäts-Kinderklinik Freiburg Not yet recruiting
Freiburg, Germany, 79106
Contact: C. Niemeyer, Prof. Dr.            
Sub-Investigator: C. Niemeyer, Prof. Dr.            
Klinikum der Justus-Liebig-Universität Recruiting
Gießen, Germany, 35392
Contact: A. Reiter, Prof. Dr.            
Sub-Investigator: A. Reiter, Prof. Dr.            
Georg-August-Universität Not yet recruiting
Göttingen, Germany, 37075
Contact: M. Lakomek, Prof. Dr.            
Sub-Investigator: M. Lakomek, Prof. Dr.            
Universitäts-Kinderklinik Hamburg Not yet recruiting
Hamburg, Germany, 20251
Contact: Schnepperheim, Prof. Dr.            
Sub-Investigator: Schneppperheim, Prof. Dr.            
Kinderklinik der Medizinischen Hochschule Not yet recruiting
Hannover, Germany, 30625
Contact: K. Welte, Prof. Dr.            
Sub-Investigator: K. Welte, Prof. Dr.            
Universitäts-Kinderklinik Not yet recruiting
Heidelberg, Germany, 69112
Contact: Kulozik, Prof. Dr.            
Sub-Investigator: Kulozik, Prof. Dr.            
Universitätsklinik der technischen Universität Dresden Not yet recruiting
Dresden, Germany, 01307
Contact: M. Suttreo, Prof. Dr.            
Sub-Investigator: M. Suttrop, Prof. Dr.            
Städtisches Klinikum Karlruhe Not yet recruiting
Karlsruhe, Germany, 76131
Contact: G. Neßler, Dr. med.            
Sub-Investigator: G. Neßler, Dr. med.            
Klinikum der Universität Kiel Recruiting
Kiel, Germany, 24105
Contact: Claviez, Dr.            
Sub-Investigator: Claviez, Dr.            
Klinikum der Stadt Köln Not yet recruiting
Köln, Germany, 50735
Contact: Weiß, Prof. Dr.            
Sub-Investigator: Weiß, Prof. Dr.            
Universitäts-Kinderklinik Not yet recruiting
Köln, Germany, 50931
Contact: F. Berthold, Prof. Dr.            
Sub-Investigator: F. Berthold, Prof. Dr.            
Medizinische Universität zu Lübeck Not yet recruiting
Lübeck, Germany, 25538
Contact: P. Bucsky, Prof. Dr.            
Sub-Investigator: P. Bucsky, Prof. Dr.            
Städtisches Krankenhaus Technische Universität Schwabing Not yet recruiting
München, Germany, 80804
Contact: S. Burdach, Prof. Dr.            
Sub-Investigator: S. Burdach, Prof. Dr.            
Medizinische Fakultät Not yet recruiting
Magdeburg, Germany, 39120
Contact: U. Mittler, Prof. Dr.            
Sub-Investigator: U. Mittler, Prof. Dr.            
Klinikum der Johannes-Gutenberg-Universität Not yet recruiting
Mainz, Germany, 55101
Contact: P. Gutjahr, Prof. Dr.            
Sub-Investigator: P. Gutjahr, Prof. Dr.            
Dr. von Haunersches Kinderspital Not yet recruiting
München, Germany, 80337
Contact: A. Borkard, Prof. Dr.            
Sub-Investigator: A. Borkard, Prof. Dr.            
Kinderklinik St. Annastift Not yet recruiting
Ludwigshafen, Germany, 67067
Contact: Selle, Dr.            
Sub-Investigator: Selle, Dr.            
Westfälische Wilhelms-Universität Not yet recruiting
Münster, Germany, 48149
Contact: H. Jürgens, Prof. Dr.            
Sub-Investigator: H. Jürgens, Prof. Dr.            
Cnopf'sche Kinderklinik Not yet recruiting
Nürnberg, Germany, 90419
Contact: Scheuerlen, Prof. Dr.            
Sub-Investigator: Scheuerlen, Prof. Dr.            
Klinik St. Hedwig Recruiting
Regensburg, Germany, 93049
Contact: Wolf, Prof. Dr.            
Sub-Investigator: Wolf, Prof. Dr.            
Johanniter-Kinderklinik Not yet recruiting
St.Augustin, Germany, 53757
Contact: R. Dickerhoff, Dr. med.            
Sub-Investigator: R. Dickerhoff, Dr. med.            
Olgahospital Recruiting
Stuttgart, Germany, 70176
Contact: J. Treuner, Prof. Dr.            
Sub-Investigator: J. Treuner, Prof. Dr.            
Universitäts-Kinderklinik Not yet recruiting
Tübingen, Germany, 72076
Contact: D. Niethammer, Prof. Dr.            
Sub-Investigator: D. Niethammer, Prof. Dr.            
Universitäts-Kinderklinik Not yet recruiting
Ulm, Germany, 89075
Contact: M. Debatin, Prof. Dr.            
Sub-Investigator: M. Debatin, Prof. Dr.            
Universitäts-Kinderklinik Not yet recruiting
Würzburg, Germany, 97080
Contact: P. G. Schlegel, Prof. Dr.            
Sub-Investigator: P. G. Schlegel, Prof. Dr.            
Germany, Sachsen
HELIOS Klinikum Erfurt GmbH Recruiting
Erfurt, Sachsen, Germany, 99089
Contact: Axel Sauerbrey, Prof.     (03 61) 7 81-45 01     asauerbrey@erfurt.helios-kliniken.de    
Principal Investigator: Axel Sauerbrey, Prof.            
Sponsors and Collaborators
Cooperative Weichteilsarkom Gruppe
Deutsche Krebshilfe e.V., Bonn (Germany)
Investigators
Study Chair: Thomas Klingebiel, Prof. Dr. Klinikum der Johann Wolfgang Goethe-Universität
  More Information

Study ID Numbers: CWS-IV 2002
Study First Received: August 15, 2005
Last Updated: September 8, 2006
ClinicalTrials.gov Identifier: NCT00130858  
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Cooperative Weichteilsarkom Gruppe:
Sarcoma, Soft Tissue

Study placed in the following topic categories:
Neoplasms, Connective and Soft Tissue
Malignant mesenchymal tumor
Sarcoma
 Carboplatin
Topotecan
Soft tissue sarcomas

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009



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