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EpSSG (European Soft Tissue Sarcoma Study Group) Protocol for Non-Metastatic Rhabdomyosarcoma in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00339118
Recruitment Status : Unknown
Verified June 2006 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 20, 2006
Last Update Posted : June 20, 2006
Sponsor:
Information provided by:
Sheba Medical Center

Tracking Information
First Submitted Date  ICMJE June 19, 2006
First Posted Date  ICMJE June 20, 2006
Last Update Posted Date June 20, 2006
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2006)
  • event free survival
  • overall survival
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EpSSG (European Soft Tissue Sarcoma Study Group) Protocol for Non-Metastatic Rhabdomyosarcoma in Children
Official Title  ICMJE Not Provided
Brief Summary The purpose of the study is achieve standardization treatment of low and intermediate risk rhabdomyosarcoma patients, with an attempt to improve treatment results in high and very high risk patients by the addition of doxorubicin as induction treatment and at the maintenance phase.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Rhabdomyosarcoma
Intervention  ICMJE Drug: doxorubicin, cytoxan
Study Arms  ICMJE Not Provided
Publications * Bisogno G, De Salvo GL, Bergeron C, Gallego Melcon S, Merks JH, Kelsey A, Martelli H, Minard-Colin V, Orbach D, Glosli H, Chisholm J, Casanova M, Zanetti I, Devalck C, Ben-Arush M, Mudry P, Ferman S, Jenney M, Ferrari A; European paediatric Soft tissue sarcoma Study Group. Vinorelbine and continuous low-dose cyclophosphamide as maintenance chemotherapy in patients with high-risk rhabdomyosarcoma (RMS 2005): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2019 Nov;20(11):1566-1575. doi: 10.1016/S1470-2045(19)30617-5. Epub 2019 Sep 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • child
  • non metastatic rhabdomyosarcoma
  • adequate heart, kidney, liver function

Exclusion Criteria:

  • age over 21 years, under 6 months
  • metastatic disease
  • heart, kidney, liver disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00339118
Other Study ID Numbers  ICMJE SHEBA-06-4013-IK-CTIL
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sheba Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Iris Kventsel, MD Sheba Medical Center
PRS Account Sheba Medical Center
Verification Date June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP