NCT00025428

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: Phase III trial to determine the effectiveness of combination chemotherapy given before surgery in treating children who have localized neuroblastoma.

Trial Health

98
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2000

Longer than P75 for phase_3

Geographic Reach
12 countries

12 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

December 1, 2000

Completed
10 months 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
10.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

December 4, 2013

Status Verified

November 1, 2006

First QC Date

October 11, 2001

Last Update Submit

December 3, 2013

Conditions

Neuroblastoma

Keywords

localized unresectable neuroblastoma

Outcome Measures

Primary Outcomes (1)

  • Event-free survival at 3 years

Interventions

carboplatinDRUG
cyclophosphamideDRUG
doxorubicin hydrochlorideDRUG
etoposideDRUG
vincristine sulfateDRUG
adjuvant therapyPROCEDURE
conventional surgeryPROCEDURE
neoadjuvant therapyPROCEDURE

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: * Diagnosis of localized unresectable neuroblastoma * Stage II or III * No MYCN amplification PATIENT CHARACTERISTICS: Age: * Over 1 Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy 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 (12)

St. Anna Children's Hospital

Vienna, A-1090, Austria

Location

Universitair Ziekenhuis Gent

Ghent, B-9000, Belgium

Location

Odense University Hospital

Odense, DK-5000, Denmark

Location

Centre Hospitalier Regional de Purpan

Toulouse, 31026, France

Location

Children's Hospital

Cologne, D-50924, Germany

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

Southampton University Hospital NHS Trust

Southampton, England, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Neuroblastoma

Interventions

CarboplatinCyclophosphamideDoxorubicinEtoposideVincristineChemotherapy, AdjuvantNeoadjuvant Therapy

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-RingIndolizidinesIndolizinesCombined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Janice A. Kohler, MD, FRCP

    University Hospital Southampton NHS Foundation Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 11, 2001

First Posted

January 27, 2003

Study Start

December 1, 2000

Study Completion

November 1, 2013

Last Updated

December 4, 2013

Record last verified: 2006-11

Locations

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