Clinical trial NCT00130858: a Multicenter Clinical Trial for the Treatment of Children and Adolescents With Soft Tissue Sarcoma Stage 4
Official title: a Multicenter Clinical Trial for the Treatment of Children and Adolescents With Soft Tissue Sarcoma Stage 4
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sarcoma, Soft Tissue
Keywords: Sarcoma, Soft Tissue
Lead sponsor: Cooperative Weichteilsarkom Study Group
Sponsor class: OTHER
Collaborators: name: Deutsche Krebshilfe e.V., Bonn (Germany)
First posted: 2005-08-16
Enrollment: 90
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Response according to RECIST criteria
Secondary outcomes:
measure: Toxicity
measure: Overall-Survival
measure: Event-free-survival
Other outcomes:
Locations:
city: Erfurt
country: Germany
facility: HELIOS Klinikum Erfurt GmbH
state: Sachsen
city: Augsburg
country: Germany
facility: Zentralklinikum
city: Berlin
country: Germany
facility: Klinikum Berlin-Buch
city: Berlin
country: Germany
facility: Virchow Klinik
city: Bonn
country: Germany
facility: Zentrum für Kinderheilkunde
city: Bremen
country: Germany
facility: Zentralkrankenhaus Bremen
city: Dresden
country: Germany
facility: Universitätsklinik der technischen Universität Dresden
city: Düsseldorf
country: Germany
facility: Heinrich-Heine-Universität
city: Erlangen
country: Germany
facility: Universitätsklinik für Kinderund Jugendliche
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Frankfurt
country: Germany
facility: Klinikum der Universität
city: Freiburg
country: Germany
facility: Universitäts-Kinderklinik Freiburg
city: Gießen
country: Germany
facility: Klinikum der Justus-Liebig-Universität
city: Göttingen
country: Germany
facility: Georg-August-Universität
city: Hamburg
country: Germany
facility: Universitäts-Kinderklinik Hamburg
city: Hannover
country: Germany
facility: Kinderklinik der Medizinischen Hochschule
city: Heidelberg
country: Germany
facility: Universitäts-Kinderklinik
city: Homburg/saar
country: Germany
facility: Universitäts-Kinderklinik
city: Jena
country: Germany
facility: Klinik für Kinder- und Jugendmedizin
city: Karlsruhe
country: Germany
facility: Städtisches Klinikum Karlruhe
city: Kiel
country: Germany
facility: Klinikum der Universität Kiel
city: Köln
country: Germany
facility: Klinikum der Stadt Köln
city: Köln
country: Germany
facility: Universitäts-Kinderklinik
city: Leipzig
country: Germany
facility: Universitätsklinik und Poliklinik
city: Ludwigshafen
country: Germany
facility: Kinderklinik St. Annastift
city: Lübeck
country: Germany
facility: Medizinische Universität zu Lübeck
city: Magdeburg
country: Germany
facility: Medizinische Fakultät
city: Mainz
country: Germany
facility: Klinikum der Johannes-Gutenberg-Universität
city: München
country: Germany
facility: Dr. von Haunersches Kinderspital
city: München
country: Germany
facility: Städtisches Krankenhaus Technische Universität Schwabing
city: Münster
country: Germany
facility: Westfälische Wilhelms-Universität
city: Nürnberg
country: Germany
facility: Cnopf'sche Kinderklinik
city: Regensburg
country: Germany
facility: Klinik St. Hedwig
city: St.Augustin
country: Germany
facility: Johanniter-Kinderklinik
city: Stuttgart
country: Germany
facility: Olgahospital
city: Tübingen
country: Germany
facility: Universitäts-Kinderklinik
city: Ulm
country: Germany
facility: Universitäts-Kinderklinik
city: Würzburg
country: Germany
facility: Universitäts-Kinderklinik
Study officials:
affiliation: Klinikum der Johann Wolfgang Goethe-Universität
name: Thomas Klingebiel, Prof. Dr.
role: STUDY_CHAIR
References: