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Sarcoma, Soft TissuePhase 2NCT00130858

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

A Phase 2 study testing Topotecan and Carboplatin in people with Sarcoma, Soft Tissue, run by Cooperative Weichteilsarkom Study Group at 38 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Phase II Study to evaluate the response on two blocks of topotecan and carboplatin Read more about this study

Who is it for?
Ages Up to 21 years
Conditions the study is for
Sarcoma, Soft Tissue
What is being tested?
Topotecan and Carboplatin
How many people
90 participants
Where
38 sitesGermany
Study dates
Jan 2005to Mar 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

Germany38 sites

  • Zentralklinikum

    Augsburg, 86156

  • Klinikum Berlin-Buch

    Berlin, 13125

  • Virchow Klinik

    Berlin, 13353

  • Zentrum für Kinderheilkunde

    Bonn, 53113

  • Zentralkrankenhaus Bremen

    Bremen, 28205

  • Klinikum der Stadt Köln

    Cologne, 50735

  • Universitäts-Kinderklinik

    Cologne, 50931

  • Universitätsklinik der technischen Universität Dresden

    Dresden, 01307

  • Heinrich-Heine-Universität

    Düsseldorf, 40001

  • HELIOS Klinikum Erfurt GmbH

    Erfurt, Saxony, 99089

  • Universitätsklinik für Kinderund Jugendliche

    Erlangen, 91054

  • Universitätsklinikum Essen

    Essen, 45147

  • Klinikum der Universität

    Frankfurt, 60590

  • Universitäts-Kinderklinik Freiburg

    Freiburg im Breisgau, 79106

  • Klinikum der Justus-Liebig-Universität

    Giessen, 35392

  • Georg-August-Universität

    Göttingen, 37075

  • Universitäts-Kinderklinik Hamburg

    Hamburg, 20251

  • Kinderklinik der Medizinischen Hochschule

    Hanover, 30625

  • Universitäts-Kinderklinik

    Heidelberg, 69112

  • Universitäts-Kinderklinik

    Homburg/saar, 66421

  • Klinik für Kinder- und Jugendmedizin

    Jena, 07740

  • Städtisches Klinikum Karlruhe

    Karlsruhe, 76131

  • Klinikum der Universität Kiel

    Kiel, 24105

  • Universitätsklinik und Poliklinik

    Leipzig, 04137

  • Medizinische Universität zu Lübeck

    Lübeck, 25538

  • Kinderklinik St. Annastift

    Ludwigshafen, 67067

  • Medizinische Fakultät

    Magdeburg, 39120

  • Klinikum der Johannes-Gutenberg-Universität

    Mainz, 55101

  • Dr. von Haunersches Kinderspital

    München, 80337

  • Städtisches Krankenhaus Technische Universität Schwabing

    München, 80804

  • Westfälische Wilhelms-Universität

    Münster, 48149

  • Cnopf'sche Kinderklinik

    Nuremberg, 90419

  • Klinik St. Hedwig

    Regensburg, 93049

  • Johanniter-Kinderklinik

    Sankt Augustin, 53757

  • Olgahospital

    Stuttgart, 70176

  • Universitäts-Kinderklinik

    Tübingen, 72076

  • Universitäts-Kinderklinik

    Ulm, 89075

  • Universitäts-Kinderklinik

    Würzburg, 97080

Other trials in Germany

About this study

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

Read the 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

Being tested
Topotecan, Carboplatin
Keywords
Sarcoma, Soft Tissue
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response according to RECIST criteria

Secondary outcomes (3)

  1. Toxicity

  2. Overall-Survival

  3. Event-free-survival

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2005 (estimated)
  2. Study startJan 2005
  3. Primary completionDec 2007
  4. Study completionMar 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00130858
Sponsor's protocol ID
CWS-IV 2002
Status last verified
Apr 2009
First submitted
15 Aug 2005
Last updated
2 Apr 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Topotecan and Carboplatin in people with Sarcoma, Soft Tissue, run by Cooperative Weichteilsarkom Study Group at 38 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response according to RECIST criteria. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00130858.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2009.

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