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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


Phase 3
6 Months
21 Years
Open (Enrolling)
Both
Soft Tissue Sarcoma

Thank you

Trial Information

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


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

event free survival (EFS)

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Ewa Koscielniak, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Olgahospital, CWS

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

CWS-2007-HR

NCT ID:

NCT00876031

Start Date:

July 2009

Completion Date:

July 2020

Related Keywords:

  • Soft Tissue Sarcoma
  • pediatric soft tissue sarcoma
  • rhabdomyosarcoma
  • extraosseous Ewing family tumours
  • synovial sarcoma
  • undifferentiated sarcoma
  • Rhabdomyosarcoma
  • Sarcoma

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