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

NCT ID: NCT00130858

Last Updated: 2009-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2009-03-31

Brief Summary

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

Detailed Description

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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

Conditions

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Sarcoma, Soft Tissue

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Topotecan

Intervention Type DRUG

Carboplatin

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deutsche Krebshilfe e.V., Bonn (Germany)

OTHER

Sponsor Role collaborator

Cooperative Weichteilsarkom Study Group

OTHER

Sponsor Role lead

Principal Investigators

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Thomas Klingebiel, Prof. Dr.

Role: STUDY_CHAIR

Klinikum der Johann Wolfgang Goethe-Universität

Locations

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HELIOS Klinikum Erfurt GmbH

Erfurt, Saxony, Germany

Site Status

Zentralklinikum

Augsburg, , Germany

Site Status

Klinikum Berlin-Buch

Berlin, , Germany

Site Status

Virchow Klinik

Berlin, , Germany

Site Status

Zentrum für Kinderheilkunde

Bonn, , Germany

Site Status

Zentralkrankenhaus Bremen

Bremen, , Germany

Site Status

Klinikum der Stadt Köln

Cologne, , Germany

Site Status

Universitäts-Kinderklinik

Cologne, , Germany

Site Status

Universitätsklinik der technischen Universität Dresden

Dresden, , Germany

Site Status

Heinrich-Heine-Universität

Düsseldorf, , Germany

Site Status

Universitätsklinik für Kinderund Jugendliche

Erlangen, , Germany

Site Status

Universitätsklinikum Essen

Essen, , Germany

Site Status

Klinikum der Universität

Frankfurt, , Germany

Site Status

Universitäts-Kinderklinik Freiburg

Freiburg im Breisgau, , Germany

Site Status

Klinikum der Justus-Liebig-Universität

Giessen, , Germany

Site Status

Georg-August-Universität

Göttingen, , Germany

Site Status

Universitäts-Kinderklinik Hamburg

Hamburg, , Germany

Site Status

Kinderklinik der Medizinischen Hochschule

Hanover, , Germany

Site Status

Universitäts-Kinderklinik

Heidelberg, , Germany

Site Status

Universitäts-Kinderklinik

Homburg/saar, , Germany

Site Status

Klinik für Kinder- und Jugendmedizin

Jena, , Germany

Site Status

Städtisches Klinikum Karlruhe

Karlsruhe, , Germany

Site Status

Klinikum der Universität Kiel

Kiel, , Germany

Site Status

Universitätsklinik und Poliklinik

Leipzig, , Germany

Site Status

Kinderklinik St. Annastift

Ludwigshafen, , Germany

Site Status

Medizinische Universität zu Lübeck

Lübeck, , Germany

Site Status

Medizinische Fakultät

Magdeburg, , Germany

Site Status

Klinikum der Johannes-Gutenberg-Universität

Mainz, , Germany

Site Status

Dr. von Haunersches Kinderspital

München, , Germany

Site Status

Städtisches Krankenhaus Technische Universität Schwabing

München, , Germany

Site Status

Westfälische Wilhelms-Universität

Münster, , Germany

Site Status

Cnopf'sche Kinderklinik

Nuremberg, , Germany

Site Status

Klinik St. Hedwig

Regensburg, , Germany

Site Status

Johanniter-Kinderklinik

Sankt Augustin, , Germany

Site Status

Olgahospital

Stuttgart, , Germany

Site Status

Universitäts-Kinderklinik

Tübingen, , Germany

Site Status

Universitäts-Kinderklinik

Ulm, , Germany

Site Status

Universitäts-Kinderklinik

Würzburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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CWS-IV 2002

Identifier Type: -

Identifier Source: org_study_id

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