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


Phase 2
N/A
21 Years
Not Enrolling
Both
Sarcoma, Soft Tissue

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response according to RECIST criteria

Principal Investigator

Thomas Klingebiel, Prof. Dr.

Investigator Role:

Study Chair

Investigator Affiliation:

Klinikum der Johann Wolfgang Goethe-Universit├Ąt

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

CWS-IV 2002

NCT ID:

NCT00130858

Start Date:

January 2005

Completion Date:

March 2009

Related Keywords:

  • Sarcoma, Soft Tissue
  • Sarcoma, Soft Tissue
  • Sarcoma

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