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

NCT ID: NCT00339118

Last Updated: 2006-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Conditions

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Rhabdomyosarcoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Interventions

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doxorubicin, cytoxan

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Iris Kventsel, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Central Contacts

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Iris Kventsel, MD

Role: CONTACT

97235303037

References

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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.

Reference Type DERIVED
PMID: 40053891 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36848614 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31562043 (View on PubMed)

Other Identifiers

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SHEBA-06-4013-IK-CTIL

Identifier Type: -

Identifier Source: org_study_id