NCT00339118

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.

Trial Health

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 20, 2006

Completed
Last Updated

June 20, 2006

Status Verified

June 1, 2006

First QC Date

June 19, 2006

Last Update Submit

June 19, 2006

Conditions

Rhabdomyosarcoma

Outcome Measures

Primary Outcomes (2)

  • event free survival

  • overall survival

Interventions

doxorubicin, cytoxanDRUG

Eligibility Criteria

Age6 Months - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • age over 21 years, under 6 months
  • metastatic disease
  • heart, kidney, liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Bisogno G, Chisholm J, Hladun R, De Salvo GL, Guerin F, Casanova M, Mandeville H, Alaggio R, Coppadoro B, Orbach D, Ferrari A, van Rijn R, Defachelles AS, Ben-Arush M, Glosli H, Cesen M, Merks JHM, Minard-Colin V. Maintenance Chemotherapy in Patients With High-Risk Rhabdomyosarcoma: Long-Term Survival Analysis of the European Paediatric Soft Tissue Sarcoma Study Group RMS 2005 Trial. J Clin Oncol. 2025 Jun;43(16):1856-1862. doi: 10.1200/JCO-24-02850. Epub 2025 Mar 7.

    PMID: 40053891DERIVED

  • Bisogno G, Minard-Colin V, Zanetti I, Ferrari A, Gallego S, Davila Fajardo R, Mandeville H, Kelsey A, Alaggio R, Orbach D, Terwisscha van Scheltinga S, Guillen Burrieza G, Ben-Arush M, Glosli H, Mudry P, Ferman S, Devalck C, Defachelles AS, Merks JHM, Jenney M. Nonmetastatic Rhabdomyosarcoma in Children and Adolescents: Overall Results of the European Pediatric Soft Tissue Sarcoma Study Group RMS2005 Study. J Clin Oncol. 2023 May 1;41(13):2342-2349. doi: 10.1200/JCO.22.02093. Epub 2023 Feb 27.

    PMID: 36848614DERIVED

  • 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.

    PMID: 31562043DERIVED

MeSH Terms

Conditions

Rhabdomyosarcoma

Interventions

DoxorubicinCyclophosphamide

Condition Hierarchy (Ancestors)

MyosarcomaNeoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSarcoma

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Iris Kventsel, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Iris Kventsel, MD

CONTACT

97235303037iris.kventsel@sheba.health.gov.il

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 20, 2006

Last Updated

June 20, 2006

Record last verified: 2006-06