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

Phase 3

Completed

• Conditions: Soft Tissue Sarcoma
• Interventions: Drug: trofosfamide, idarubicin, etoposide

• Registration Number: NCT00876031
• Lead Sponsor: University Hospital Tuebingen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-02
• Study First Submitted QC: 2009-04-02
• Study First Posted: 2009-04-06
• Study Start: 2009-07-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 195

Inclusion Criteria

• written informed consent for registration, randomisation, data collection/transfer, and tumour material asservation available

• pathologically (including molecular pathology) proven diagnosis of rhabdomyosarcoma (RMS) or RMS-like soft tissue sarcoma (STS) and tumour material available for pathology review

• Rhabdomyosarcoma of the "High Risk" Group, i.e.:

  • RME, N0, M0, IRS II&III, >5 cm or >10 years in EXT, HN-PM, OTH, UG-BP
  • RME, N1, M0, any IRS-group, any size or age
  • RMA, NO, M0, any IRS-group, any size or age (exception: paratesticular RMA are not eligible) or

• Rhabdomyosarcoma of the "Very High Risk" Group, i.e.:

  • RMA, N1, MO, IRS II&III, any size or age or
  • localised high-risk RMS-like Soft Tissue Sarcoma, i.e.:
  • EES, pPNET, UDS: any N, M0, any IRS-group, any size or age
  • SySa, any N, M0, any size or age (exception: SySa IRSI&II, not T2b, N0, M0 are not eligible)

• no pre-existing illness preventing treatment (esp. those listed in the medicinal product information, e.g. cardiac, hepatic, metabolic, or renal dysfunction; hypersensitivity)

• no previous malignant tumours

• available for long term follow up through the treating centre

• in remission (according to the CWS-2007-HR definition (see X7.1.8X)) at the time of randomisation after standard multimodal therapy e.g. according to the CWS-guidance

Exclusion Criteria

• pregnant or lactating women
• other medical condition precluding treatment with protocol therapy (e.g. HIV, psychiatric disorder, etc.)
• for sexually active females and males in Arm B (O-TIE treatment): refusal to use effective contraception (e.g. oral, IUD)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
O-TIE	trofosfamide, idarubicin, etoposide	oral maintenance therapy with trofosfamide, idarubicin, and etoposide

Primary Outcome Measures

Name	Time	Method
event free survival (EFS)	3 years

Secondary Outcome Measures

Name	Time	Method
Overall survival	5 years

Trial Locations

Locations (55)

Krankenhaus der Stadt Dornbirn; 🇦🇹 Dornbirn, Austria

Universitätsklinik für Kinder- und Jugendheilkunde; 🇦🇹 Innsbruck, Austria

Landeskrankenhaus; 🇦🇹 Leoben, Austria

Landesfrauen - und Kinderklinik Linz; 🇦🇹 Linz, Austria

St. Johanns Spital / Landeskrankenhaus; 🇦🇹 Salzburg, Austria

St. Anna Kinderspital; 🇦🇹 Wien, Austria

Universitätsklinikum; 🇩🇪 Würzburg, Germany

Klinikum Augsburg; 🇩🇪 Augsburg, Germany

Charité; 🇩🇪 Berlin, Germany

Helios Klinikum Berlin-Buch; 🇩🇪 Berlin, Germany

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