a Multicenter Clinical Trial for the Treatment of Children and Adolescents With Soft Tissue Sarcoma Stage 4
N/A
21 Years
Both
Sarcoma, Soft Tissue
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-Universität
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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