NCT00162695

Brief Summary

Objective of the study objectives was to explore survival advantage for an intensified chemotherapy strategy in a randomised trial. IVA (ifosfamide, vincristine, actinomycin D) or a 6 drug combination (IVA + carboplatin, epirubicin, etoposide) both delivered over 27 weeks. Cumulative dose / m2 = ifosfamide 54g (both arms), epirubicin 450 mg, etoposide 1350 mg (6 drug). Delivery of radiotherapy was determined according to site and / or response to chemotherapy ± surgery. The study was powered to detect 10% difference in 3 year OS.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1995

Completed
10.2 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
Last Updated

September 13, 2005

Status Verified

September 1, 2005

First QC Date

September 9, 2005

Last Update Submit

September 9, 2005

Conditions

RhabdomyosarcomaMalignant Soft Tissue

Outcome Measures

Primary Outcomes (1)

  • To explore survival advantage for an intensified chemotherapy strategy in a randomised trial

Interventions

Ifosfamide, oncovin, actinomycine D, epirubicine, carboplatinum, etoposideDRUG

Eligibility Criteria

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

You may qualify if:

  • age \> 6 months and \< 18 years
  • no distant metastases
  • diagnosis within previous 8 weeks without prior treatment except surgery
  • pathology available for central review
  • written consent according to institutional requirement

You may not qualify if:

  • stage III (node positive)
  • stage I or II non alveolar orbital tumours
  • patients with parameningeal disease aged \< 3 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Gustave Roussy

Villejuif, 94800, France

Location

MeSH Terms

Conditions

Rhabdomyosarcoma

Interventions

IfosfamideVincristineEpirubicinCarboplatinEtoposide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

CyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesDoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesCoordination ComplexesPodophyllotoxinTetrahydronaphthalenesNaphthalenesGlucosides

Study Officials

  • Odile OBERLIN, Dr

    Gustave Roussy, Cancer Campus, Grand Paris

    PRINCIPAL INVESTIGATOR

  • Michael STEVENS, Dr

    Hospital of Bristols, UK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 13, 2005

Study Start

July 1, 1995

Last Updated

September 13, 2005

Record last verified: 2005-09

Locations

FR(1)