At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 195 enrolled
Drug / intervention
trofosfamide, idarubicin, etoposidedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised Phase-III Trial of the Cooperative Weichteilsarkom Study Group (CWS) for Localised High-risk Rhabdomyosarcoma and Localised Rhabdomyosarcoma-like Soft Tissue Sarcoma in Children, Adolescents, and Young Adults
In Brief
A Phase 3 clinical trial evaluating trofosfamide, idarubicin, etoposide for Soft Tissue Sarcoma. Completed, enrolled 195 participants across 87 sites in 5 countries.
Detailed Summary
The purpose of this study is to investigate whether the addition of oral maintenance chemotherapy with O-TIE (Etoposide, Idarubicin, Trofosfamide) for 6 months improves the event free survival (EFS) in patients with localised high-risk RMS and RMS-like Soft Tissue Sarcoma.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSoft Tissue Sarcoma
CountriesAustria, Germany, Poland, Sweden, Switzerland
CollaboratorsCooperative Weichteilsarkom Study Group, Deutsche Kinderkrebsstiftung, German Society for Pediatric Oncology and Hematology GPOH gGmbH, Gesellschaft fur Padiatrische Onkologie und Hamatologie - Austria, The Swedish Childhood Solid Tumor Working Group, Polish Paediatric Solid Tumours Study Group, Swiss Pediatric Oncology Group
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2009
Enrollment StartJul 2009
Primary CompletionJun 2022
TodayJul 2026
First PostedApr 6, 2009
Enrollment StartJul 1, 2009
Primary CompletionJun 30, 2022
TodayJul 2, 2026
Enrollment to primary: 13.0 yearsPosted 17.2 years ago
Interventions
trofosfamide, idarubicin, etoposidedrug
oral maintenance therapy for 6 months