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Completed

NCT Number: NCT00130858

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

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

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Key information

Conditions

Sarcoma, Soft Tissue Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Sarcoma

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

HELIOS Klinikum Erfurt GmbH, Erfurt, Saxony, Germany

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topotecan

Drug

carboplatin

Drug

Primary outcomes

  1. Response according to RECIST criteria

Secondary outcomes

  1. Toxicity

  2. Overall-Survival

  3. Event-free-survival

Sponsors and collaborators

Lead sponsor

Cooperative Weichteilsarkom Study Group

Other

Collaborators

  • Deutsche Krebshilfe e.V., Bonn (Germany)

Registry information

Important dates

Study start
2005
Primary completion
2007
Study completion
2009
First posted
Aug 16, 2005
Registry last updated
Apr 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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