Back to results

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

Primary Purpose

Sarcoma, Soft Tissue

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Topotecan

Carboplatin

About this trial

This is an interventional treatment trial for Sarcoma, Soft Tissue focused on measuring Sarcoma, Soft Tissue

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Outcomes

Primary Outcome Measures

Response according to RECIST criteria

Secondary Outcome Measures

Toxicity

Overall-Survival

Event-free-survival

Full Information

NCT ID

NCT00130858

First Posted

August 15, 2005

Last Updated

April 1, 2009

Sponsor

Cooperative Weichteilsarkom Study Group

Collaborators

Deutsche Krebshilfe e.V., Bonn (Germany)

1. Study Identification

Unique Protocol Identification Number

NCT00130858

Brief Title

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

2. Study Status

Record Verification Date

April 2009

Overall Recruitment Status

Completed

Study Start Date

January 2005 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Cooperative Weichteilsarkom Study Group

Collaborators

Deutsche Krebshilfe e.V., Bonn (Germany)

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcoma, Soft Tissue

Keywords

Sarcoma, Soft Tissue

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Topotecan

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Primary Outcome Measure Information:

Title

Response according to RECIST criteria

Secondary Outcome Measure Information:

Title

Toxicity

Title

Overall-Survival

Title

Event-free-survival

10. Eligibility

Sex

All

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Klingebiel, Prof. Dr.

Organizational Affiliation

Klinikum der Johann Wolfgang Goethe-Universität

Official's Role

Study Chair

Facility Information:

Facility Name

HELIOS Klinikum Erfurt GmbH

City

Erfurt

State/Province

Sachsen

ZIP/Postal Code

99089

Country

Germany

Facility Name

Zentralklinikum

City

Augsburg

ZIP/Postal Code

86156

Country

Germany

Facility Name

Klinikum Berlin-Buch

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Facility Name

Virchow Klinik

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Zentrum für Kinderheilkunde

City

Bonn

ZIP/Postal Code

53113

Country

Germany

Facility Name

Zentralkrankenhaus Bremen

City

Bremen

ZIP/Postal Code

28205

Country

Germany

Facility Name

Universitätsklinik der technischen Universität Dresden

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Heinrich-Heine-Universität

City

Düsseldorf

ZIP/Postal Code

40001

Country

Germany

Facility Name

Universitätsklinik für Kinderund Jugendliche

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Universitätsklinikum Essen

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

Klinikum der Universität

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

Universitäts-Kinderklinik Freiburg

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Klinikum der Justus-Liebig-Universität

City

Gießen

ZIP/Postal Code

35392

Country

Germany

Facility Name

Georg-August-Universität

City

Göttingen

ZIP/Postal Code

37075

Country

Germany

Facility Name

Universitäts-Kinderklinik Hamburg

City

Hamburg

ZIP/Postal Code

20251

Country

Germany

Facility Name

Kinderklinik der Medizinischen Hochschule

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Universitäts-Kinderklinik

City

Heidelberg

ZIP/Postal Code

69112

Country

Germany

Facility Name

Universitäts-Kinderklinik

City

Homburg/saar

ZIP/Postal Code

66421

Country

Germany

Facility Name

Klinik für Kinder- und Jugendmedizin

City

Jena

ZIP/Postal Code

07740

Country

Germany

Facility Name

Städtisches Klinikum Karlruhe

City

Karlsruhe

ZIP/Postal Code

76131

Country

Germany

Facility Name

Klinikum der Universität Kiel

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

Klinikum der Stadt Köln

City

Köln

ZIP/Postal Code

50735

Country

Germany

Facility Name

Universitäts-Kinderklinik

City

Köln

ZIP/Postal Code

50931

Country

Germany

Facility Name

Universitätsklinik und Poliklinik

City

Leipzig

ZIP/Postal Code

04137

Country

Germany

Facility Name

Kinderklinik St. Annastift

City

Ludwigshafen

ZIP/Postal Code

67067

Country

Germany

Facility Name

Medizinische Universität zu Lübeck

City

Lübeck

ZIP/Postal Code

25538

Country

Germany

Facility Name

Medizinische Fakultät

City

Magdeburg

ZIP/Postal Code

39120

Country

Germany

Facility Name

Klinikum der Johannes-Gutenberg-Universität

City

Mainz

ZIP/Postal Code

55101

Country

Germany

Facility Name

Dr. von Haunersches Kinderspital

City

München

ZIP/Postal Code

80337

Country

Germany

Facility Name

Städtisches Krankenhaus Technische Universität Schwabing

City

München

ZIP/Postal Code

80804

Country

Germany

Facility Name

Westfälische Wilhelms-Universität

City

Münster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Cnopf'sche Kinderklinik

City

Nürnberg

ZIP/Postal Code

90419

Country

Germany

Facility Name

Klinik St. Hedwig

City

Regensburg

ZIP/Postal Code

93049

Country

Germany

Facility Name

Johanniter-Kinderklinik

City

St.Augustin

ZIP/Postal Code

53757

Country

Germany

Facility Name

Olgahospital

City

Stuttgart

ZIP/Postal Code

70176

Country

Germany

Facility Name

Universitäts-Kinderklinik

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Universitäts-Kinderklinik

City

Ulm

ZIP/Postal Code

89075

Country

Germany

Facility Name

Universitäts-Kinderklinik

City

Würzburg

ZIP/Postal Code

97080

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs

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

Sarcoma, Soft Tissue

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial