NCT00130858

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2005

Typical duration for phase_2

Geographic Reach
1 country

38 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 16, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

April 2, 2009

Status Verified

April 1, 2009

Enrollment Period

2.9 years

First QC Date

August 15, 2005

Last Update Submit

April 1, 2009

Conditions

Sarcoma, Soft Tissue

Keywords

Sarcoma, Soft Tissue

Outcome Measures

Primary Outcomes (1)

  • Response according to RECIST criteria

Secondary Outcomes (3)

  • Toxicity

  • Overall-Survival

  • Event-free-survival

Interventions

TopotecanDRUG
CarboplatinDRUG

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (38)

HELIOS Klinikum Erfurt GmbH

Erfurt, Saxony, 99089, Germany

Location

Zentralklinikum

Augsburg, 86156, Germany

Location

Klinikum Berlin-Buch

Berlin, 13125, Germany

Location

Virchow Klinik

Berlin, 13353, Germany

Location

Zentrum für Kinderheilkunde

Bonn, 53113, Germany

Location

Zentralkrankenhaus Bremen

Bremen, 28205, Germany

Location

Klinikum der Stadt Köln

Cologne, 50735, Germany

Location

Universitäts-Kinderklinik

Cologne, 50931, Germany

Location

Universitätsklinik der technischen Universität Dresden

Dresden, 01307, Germany

Location

Heinrich-Heine-Universität

Düsseldorf, 40001, Germany

Location

Universitätsklinik für Kinderund Jugendliche

Erlangen, 91054, Germany

Location

Universitätsklinikum Essen

Essen, 45147, Germany

Location

Klinikum der Universität

Frankfurt, 60590, Germany

Location

Universitäts-Kinderklinik Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Klinikum der Justus-Liebig-Universität

Giessen, 35392, Germany

Location

Georg-August-Universität

Göttingen, 37075, Germany

Location

Universitäts-Kinderklinik Hamburg

Hamburg, 20251, Germany

Location

Kinderklinik der Medizinischen Hochschule

Hanover, 30625, Germany

Location

Universitäts-Kinderklinik

Heidelberg, 69112, Germany

Location

Universitäts-Kinderklinik

Homburg/saar, 66421, Germany

Location

Klinik für Kinder- und Jugendmedizin

Jena, 07740, Germany

Location

Städtisches Klinikum Karlruhe

Karlsruhe, 76131, Germany

Location

Klinikum der Universität Kiel

Kiel, 24105, Germany

Location

Universitätsklinik und Poliklinik

Leipzig, 04137, Germany

Location

Kinderklinik St. Annastift

Ludwigshafen, 67067, Germany

Location

Medizinische Universität zu Lübeck

Lübeck, 25538, Germany

Location

Medizinische Fakultät

Magdeburg, 39120, Germany

Location

Klinikum der Johannes-Gutenberg-Universität

Mainz, 55101, Germany

Location

Dr. von Haunersches Kinderspital

München, 80337, Germany

Location

Städtisches Krankenhaus Technische Universität Schwabing

München, 80804, Germany

Location

Westfälische Wilhelms-Universität

Münster, 48149, Germany

Location

Cnopf'sche Kinderklinik

Nuremberg, 90419, Germany

Location

Klinik St. Hedwig

Regensburg, 93049, Germany

Location

Johanniter-Kinderklinik

Sankt Augustin, 53757, Germany

Location

Olgahospital

Stuttgart, 70176, Germany

Location

Universitäts-Kinderklinik

Tübingen, 72076, Germany

Location

Universitäts-Kinderklinik

Ulm, 89075, Germany

Location

Universitäts-Kinderklinik

Würzburg, 97080, Germany

Location

MeSH Terms

Conditions

Sarcoma

Interventions

TopotecanCarboplatin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsCoordination ComplexesOrganic Chemicals

Study Officials

  • Thomas Klingebiel, Prof. Dr.

    Klinikum der Johann Wolfgang Goethe-Universität

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 15, 2005

First Posted

August 16, 2005

Study Start

January 1, 2005

Primary Completion

December 1, 2007

Study Completion

March 1, 2009

Last Updated

April 2, 2009

Record last verified: 2009-04

Locations

DE(38)