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Trial for Localised High-risk Rhabdomyosarcoma and Rhabdomyosarcoma-like Soft Tissue Sarcoma

NCT00876031 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2022-11-08

No results posted yet for this study

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.

Conditions

  • Soft Tissue Sarcoma

Interventions

DRUG

trofosfamide, idarubicin, etoposide

oral maintenance therapy for 6 months

Sponsors & Collaborators

  • Cooperative Weichteilsarkom Study Group

    collaborator OTHER

  • Deutsche Kinderkrebsstiftung

    collaborator OTHER

  • German Society for Pediatric Oncology and Hematology GPOH gGmbH

    collaborator OTHER

  • Gesellschaft fur Padiatrische Onkologie und Hamatologie - Austria

    collaborator OTHER

  • The Swedish Childhood Solid Tumor Working Group

    collaborator UNKNOWN

  • Polish Paediatric Solid Tumours Study Group

    collaborator UNKNOWN

  • Swiss Pediatric Oncology Group

    collaborator OTHER

  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Ewa Koscielniak, MD · Olgahospital, CWS

  • Thomas Klingebiel, MD · Universitätsklinikum Frankfurt, CWS

  • Monika Sparber Sauer, MD · Olgahospital, CWS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-01
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • Austria
  • Germany
  • Poland
  • Sweden
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00876031 on ClinicalTrials.gov