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a Multicenter Clinical Trial for the Treatment of Children and Adolescents with Soft Tissue Sarcoma Stage 4 - Article


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Soft Tissue Sarcoma

Rhabdomyosarcoma; Sarcoma, Soft Tissue

Clinical Trial: a Multicenter Clinical Trial for the Treatment of Children and Adolescents with Soft Tissue Sarcoma Stage 4

This study is currently recruiting patients.
Verified by Klinikum der J.W. Goethe Universitaet August 2005

Sponsors and Collaborators: Klinikum der J.W. Goethe Universitaet
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by: Klinikum der J.W. Goethe Universitaet
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

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study

Further Study Details: 
Primary Outcomes: Response according to RECIST criteria
Secondary Outcomes: Toxicity; Overall-Survival; Event-free-survival
Expected Total Enrollment:  90

Study start: January 2005;  Expected completion: January 2010
Last follow-up: December 2007;  Data entry closure: January 2008

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
Criteria

Inclusion Criteria:

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00130858

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

Germany
      Zentralklinikum, Augsburg,  86156,  Germany; Not yet recruiting
Gnekow, Dr.
Gnekow, Dr.,  Sub-Investigator

      Virchow Klinik, Berlin,  13353,  Germany; Not yet recruiting
Henze, Prof. Dr.
Henze, Prof. Dr.,  Sub-Investigator

      Zentrum für Kinderheilkunde, Bonn,  53113,  Germany; Not yet recruiting
U. Bode, Prof. Dr.
U. Bode, Prof.Dr.,  Sub-Investigator

      Universitäts-Kinderklinik, HOMBURG / SAAR,  66421,  Germany; Recruiting
N. Graf, Prof. Dr.
N. Graf, Prof. Dr.,  Sub-Investigator

      Universitätsklinik für Kinderund Jugendliche, Erlangen,  91054,  Germany; Recruiting
J. D. Beck, Prof. Dr.
J. D. Beck, Prof. Dr.,  Sub-Investigator

      Universitätsklinik und Poliklinik, Leipzig,  04137,  Germany; Recruiting
Körholz, Prof. Dr.
Körholz, Prof. Dr.,  Sub-Investigator

      Klinikum der Universität, Frankfurt,  60590,  Germany; Not yet recruiting
Thomas Klingebiel, Prof. Dr.  (+49) 69 63 01 5094    thomas.klingenbiel@kgu.de 
Thomas Klingebiel, Prof. Dr.,  Sub-Investigator

      Klinikum Berlin-Buch, Berlin-Buch,  13125,  Germany; Not yet recruiting
W. Dörffel, Dr. med.
W. Dörffel, Dr. med.,  Sub-Investigator

      Zentralkrankenhaus Bremen, Bremen,  28205,  Germany; Not yet recruiting
Th. Lieber, Dr. med.
Th. Lieber, Dr. med.,  Sub-Investigator

      Universitätsklinik der technischen Universität Dresden, Dresden,  01307,  Germany; Not yet recruiting
M. Suttreo, Prof. Dr.
M. Suttrop, Prof. Dr.,  Sub-Investigator

      Heinrich-Heine-Universität, Düsseldorf,  40001,  Germany; Not yet recruiting
Göbel, Prof. Dr.
Göbel, Prof. Dr.,  Sub-Investigator

      Universitätsklinikum Essen, ESSEN,  45147,  Germany; Not yet recruiting
Havers, Prof. Dr.
Havers, Prof. Dr.,  Sub-Investigator

      Universitäts-Kinderklinik Freiburg, Freiburg,  79106,  Germany; Not yet recruiting
C. Niemeyer, Prof. Dr.
C. Niemeyer, Prof. Dr.,  Sub-Investigator

      Klinikum der Justus-Liebig-Universität, Giessen,  35392,  Germany; Not yet recruiting
A. Reiter, Prof. Dr.
A. Reiter, Prof. Dr.,  Sub-Investigator

      Georg-August-Universität, Göttingen,  37075,  Germany; Not yet recruiting
M. Lakomek, Prof. Dr.
M. Lakomek, Prof. Dr.,  Sub-Investigator

      Universitäts-Kinderklinik Hamburg, Hamburg,  20251,  Germany; Not yet recruiting
Schnepperheim, Prof. Dr.
Schneppperheim, Prof. Dr.,  Sub-Investigator

      Kinderklinik der Medizinischen Hochschule, Hannover,  30625,  Germany; Not yet recruiting
K. Welte, Prof. Dr.
K. Welte, Prof. Dr.,  Sub-Investigator

      Universitäts-Kinderklinik, Heidelberg,  69112,  Germany; Not yet recruiting
Kulozik, Prof. Dr.
Kulozik, Prof. Dr.,  Sub-Investigator

      Klinik für Kinder- und Jugendmedizin, Jena,  07740,  Germany; Not yet recruiting
F. Zintl, Prof. Dr.
F. Zintl, Prof. Dr.,  Sub-Investigator

      Städtisches Klinikum Karlruhe, Karlsruhe,  76131,  Germany; Not yet recruiting
G. Neßler, Dr. med.
G. Neßler, Dr. med.,  Sub-Investigator

      Klinikum der Universität Kiel, Kiel,  24105,  Germany; Not yet recruiting
Claviez, Dr.
Claviez, Dr.,  Sub-Investigator

      Klinikum der Stadt Köln, Köln,  50735,  Germany; Not yet recruiting
Weiß, Prof. Dr.
Weiß, Prof. Dr.,  Sub-Investigator

      Universitäts-Kinderklinik, Köln,  50931,  Germany; Not yet recruiting
F. Berthold, Prof. Dr.
F. Berthold, Prof. Dr.,  Sub-Investigator

      Medizinische Universität zu Lübeck, LÜBECK,  25538,  Germany; Not yet recruiting
P. Bucsky, Prof. Dr.
P. Bucsky, Prof. Dr.,  Sub-Investigator

      Kinderklinik St. Annastift, Ludwigshafen,  67067,  Germany; Not yet recruiting
Selle, Dr.
Selle, Dr.,  Sub-Investigator

      Medizinische Fakultät, Magdeburg,  39120,  Germany; Not yet recruiting
U. Mittler, Prof. Dr.
U. Mittler, Prof. Dr.,  Sub-Investigator

      Klinikum der Johannes-Gutenberg-Universität, Mainz,  55101,  Germany; Not yet recruiting
P. Gutjahr, Prof. Dr.
P. Gutjahr, Prof. Dr.,  Sub-Investigator

      Dr. von Haunersches Kinderspital, München,  80337,  Germany; Not yet recruiting
A. Borkard, Prof. Dr.
A. Borkard, Prof. Dr.,  Sub-Investigator

      Städtisches Krankenhaus Technische Universität Schwabing, München,  80804,  Germany; Not yet recruiting
S. Burdach, Prof. Dr.
S. Burdach, Prof. Dr.,  Sub-Investigator

      Westfälische Wilhelms-Universität, MÜNSTER,  48149,  Germany; Not yet recruiting
H. Jürgens, Prof. Dr.
H. Jürgens, Prof. Dr.,  Sub-Investigator

      Cnopf''''sche Kinderklinik, Nürnberg,  90419,  Germany; Not yet recruiting
Scheuerlen, Prof. Dr.
Scheuerlen, Prof. Dr.,  Sub-Investigator

      Klinik St. Hedwig, Regensburg,  93049,  Germany; Not yet recruiting
Wolf, Prof. Dr.
Wolf, Prof. Dr.,  Sub-Investigator

      Johanniter-Kinderklinik, St.Augustin,  53757,  Germany; Not yet recruiting
R. Dickerhoff, Dr. med.
R. Dickerhoff, Dr. med.,  Sub-Investigator

      Olgahospital, Stuttgart,  70176,  Germany; Not yet recruiting
J. Treuner, Prof. Dr.
J. Treuner, Prof. Dr.,  Sub-Investigator

      Universitäts-Kinderklinik, Tübingen,  72076,  Germany; Not yet recruiting
D. Niethammer, Prof. Dr.
D. Niethammer, Prof. Dr.,  Sub-Investigator

      Universitäts-Kinderklinik, Ulm,  89075,  Germany; Not yet recruiting
M. Debatin, Prof. Dr.
M. Debatin, Prof. Dr.,  Sub-Investigator

      Universitäts-Kinderklinik, Würzburg,  97080,  Germany; Not yet recruiting
P. G. Schlegel, Prof. Dr.
P. G. Schlegel, Prof. Dr.,  Sub-Investigator

Study chairs or principal investigators

Thomas Klingebiel, Prof. Dr.,  Study Chair,  Klinikum der Johann Wolfgang Goethe-Universität   

More Information

Study ID Numbers:  CWS-IV 2002
Last Updated:  August 15, 2005
Record first received:  August 15, 2005
ClinicalTrials.gov Identifier:  NCT00130858
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-08-23


Source: ClinicalTrials.gov
Cache Date: August 24, 2005


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Page Updated: October 3, 2005
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