NCT00025597

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by surgery in treating infants who have newly diagnosed neuroblastoma.

Trial Health

98
On Track

Trial Health Score

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

Timeline
Completed

Started Jul 1999

Longer than P75 for phase_2

Geographic Reach
11 countries

11 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1999

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 11, 2001

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

September 17, 2013

Status Verified

November 1, 2001

First QC Date

October 11, 2001

Last Update Submit

September 16, 2013

Conditions

Neuroblastoma

Keywords

localized unresectable neuroblastoma

Interventions

carboplatinDRUG
cyclophosphamideDRUG
doxorubicin hydrochlorideDRUG
etoposideDRUG
vincristine sulfateDRUG
conventional surgeryPROCEDURE

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed newly diagnosed stage II or III neuroblastoma or ganglioneuroblastoma * Unresectable disease * No MYCN amplification (i.e., fewer than 10 copies) * No metastases to bone marrow * No radiological bone lesions in skeleton PATIENT CHARACTERISTICS: Age: * Under 12 months at diagnosis Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * No evidence of liver disease by ultrasound Renal: * Not specified PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (11)

St. Anna Children's Hospital

Vienna, A-1090, Austria

Location

Universitair Ziekenhuis Gent

Ghent, B-9000, Belgium

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Centre Hospitalier Regional de Purpan

Toulouse, 31026, France

Location

Istituto Giannina Gaslini

Genoa, 16148, Italy

Location

Rikshospitalet University Hospital

Oslo, 0027, Norway

Location

Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.

Lisbon, 1099-023 Codex, Portugal

Location

Hospital Universitario LA FE

Valencia, 46009, Spain

Location

Ostra Sjukhuset

Gothenburg, 41685, Sweden

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Bristol Royal Hospital for Children

Bristol, England, BS2 8BJ, United Kingdom

Location

Related Publications (1)

  • Rubie H, De Bernardi B, Gerrard M, Canete A, Ladenstein R, Couturier J, Ambros P, Munzer C, Pearson AD, Garaventa A, Brock P, Castel V, Valteau-Couanet D, Holmes K, Di Cataldo A, Brichard B, Mosseri V, Marquez C, Plantaz D, Boni L, Michon J. Excellent outcome with reduced treatment in infants with nonmetastatic and unresectable neuroblastoma without MYCN amplification: results of the prospective INES 99.1. J Clin Oncol. 2011 Feb 1;29(4):449-55. doi: 10.1200/JCO.2010.29.5196. Epub 2010 Dec 20.

    PMID: 21172879RESULT

MeSH Terms

Conditions

Neuroblastoma

Interventions

CarboplatinCyclophosphamideDoxorubicinEtoposideVincristine

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhosphoramidesOrganophosphorus CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPodophyllotoxinTetrahydronaphthalenesNaphthalenesGlucosidesVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Herve Rubie, MD

    Centre Hospitalier Regional de Purpan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 11, 2001

First Posted

January 27, 2003

Study Start

July 1, 1999

Study Completion

February 1, 2011

Last Updated

September 17, 2013

Record last verified: 2001-11

Locations

FR(1)BE(1)PT(1)NO(1)ES(1)GB(1)IT(1)AU(1)DK(1)CH(1)SE(1)