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

Cooperative Weichteilsarkom Study Group

Status and phase: Completed; Phase 2

Conditions: Sarcoma, Soft Tissue

Treatments: Drug: Carboplatin; Drug: Topotecan

Study type: Interventional

Funder types: Other

Identifiers

NCT00130858

CWS-IV 2002

Details and patient eligibility

About

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

Full 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

Enrollment: 90 estimated patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)