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NeuroblastomaPhase 2NCT00003122

Surgery in Treating Patients With Neuroblastoma

A Phase 2 study testing surgical procedure in people with Neuroblastoma, run by Societe Internationale d'Oncologie Pediatrique at 96 sites in 8 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Surgery may be an effective treatment for neuroblastoma. PURPOSE: This phase II trial is studying how well surgery works in treating patients with neuroblastoma. Read more about this study

Who is it for?
Ages Up to 20 years
Conditions the study is for
Neuroblastoma
What is being tested?
surgical procedure
Type of treatment
Surgery or procedure
How many people
210 participants
Where
96 sitesin 8 countries
Study dates
Dec 1994to not given
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

DISEASE CHARACTERISTICS:

  • Trial: Histologically proven International Neuroblastoma Staging System (INSS) stage IIA and IIB neuroblastoma without amplification of the N-myc oncogene
  • Study: Histologically proven neuroblastoma
  • Stage I
  • Stage II with amplified N-myc
  • Stage II without evaluation of N-myc
  • Stage II with symptomatic spinal cord compression
  • Stage III
  • No metastases diagnosed within 1 month of study

PATIENT CHARACTERISTICS:

Age:

  • 20 and under

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
  • No adjuvant chemotherapy planned

Endocrine therapy:

  • Prior use of steroids allowed

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Trial locations and contacts

96 sites in 8 countries.

96 sites in 8 countries

Italy27 sites, 27 recruiting

  • Universita Degli Studi di Bari

    Bari, 70124

    Serenella Bagnulo, 39-080-5478-660

    Recruiting

  • Ospedali Riuniti di Bergamo

    Bergamo, 24100

    Piermemilio Cornelli, 39-035-269-859

    Recruiting

  • Spedali Civili di Brescia

    Brescia, 25123

    Alberto Arrighini, 39-030-395-823

    Recruiting

  • Ospedale Oncologico A. Businco

    Cagliari, 09121

    Roberto Targhetta, 39-070-609-5204

    Recruiting

  • Policlinico Dell'Universita

    Catania, 95125

    Gino Schilliro, 39-095-330-533

    Recruiting

  • Ospedale Galliera

    Genoa, 16128

    Marco Cominetti, 39-010-56-321

    Recruiting

  • Istituto Giannina Gaslini

    Genoa, 16148

    Bruno De Bernardi, MD, 39-10-563-6464, brunodebernardi@ospedale-gaslini.ge.it

    Recruiting

  • Istituti Clinici di Perfezionamento

    Milan, 20122

    Maria Fagnani, 39-2-5799-1

    Recruiting

  • Fondazione Istituto Nazionale dei Tumori

    Milan, 20133

    Marco Gasparini, MD, 02-2390587

    Recruiting

  • Ospedale Niguarda Ca'Granda

    Milan, 20162

    Alvaro Moreno, 39-02-6444-2291

    Recruiting

  • Azienda Ospedaliera - Universitaria di Modena

    Modena, 41100

    Fausto Massolo, 39-059-422-4373

    Recruiting

  • Ospedale S.S. Annunziata Napoli

    Naples, 80100

    Antonio Correra, 39-081-254-2588

    Recruiting

  • Federico II University Medical School

    Naples, 80131

    Amadeo Fiorillo, 39-081-746-3772

    Recruiting

  • Clinica Pediatrica I

    Naplesi, 480138

    Maria Teresa Di Tullio, 39-081-445-255

    Recruiting

  • Azienda Ospedaliera di Padova

    Padova, 35128

    Modesto Carli, MD, 39-049-821-3579, modesto.carli@unipd.it

    Recruiting

  • Clinica Pediatrica Palermo

    Palermo, 90134

    Margherita Lo Curto, 39-091-485-292

    Recruiting

  • Azienda Ospedaliera Di Parma

    Parma, 43100

    Giancarlo Izzi, 39-521-702-441

    Recruiting

  • Fondazione I.R.C.C.S. Policlinico San Matteo

    Pavia, 27100

    Frederico Bonetti, 39-0382-502-580

    Recruiting

  • Ospedale Silvestrini

    Perugia, 06132

    Paolo Zucchetti, 39-075-578-3392

    Recruiting

  • Ospedale Santa Chiara Pisa

    Pisa, 56100

    Claudio Favre, 39-50-992-540

    Recruiting

  • Azienda Policlinico Umberto Primo

    Rome, 00161

    Manuel A. Castello, 39-06-857-951

    Recruiting

  • Ospedale Bambino Gesu

    Rome, 00165

    Alberto Donfrancesco, 39-06-6859-2351

    Recruiting

  • Clinica Ars Medica

    Rome, 00191

    Antonia Mancini, 39-06-3620-8502

    Recruiting

  • Istituto Clinica Medica

    Sassari, 07100

    Domenico Gallisai, 39-079-228-382

    Recruiting

  • University of Siena

    Siena, 53100

    Antonio Acquaviva, 39-0577-280-921

    Recruiting

  • Clinica Pediatrica Trieste

    Trieste

    Paolo Tamaro, 39-040-378-5380

    Recruiting

  • Ospedale Infantile Regina Margherita

    Turin, 10126

    Luca Cordero Di Montezemolo, 39-011-692-7230

    Recruiting

Other trials in Italy

France25 sites, 25 recruiting

  • CHR de Besancon - Hopital Saint-Jacques

    Besançon, 25030

    Emmanuel Plouvier, MD, 33-381-218-140, eplouvier@chu-besancon.fr

    Recruiting

  • CHU de Caen

    Caen, 14033

    Patrick Boutard, MD, 33-231-064-488, boutard_p@chu-caen.fr

    Recruiting

  • CHR Clermont Ferrand, Hotel Dieu

    Clermont-Ferrand, 63058

    F. Demeocq, 33-73-316-000

    Recruiting

  • Centre Hospitalier Universitaire de Dijon

    Dijon, 21079

    G. Couillault, 33-380-293-031

    Recruiting

  • CHU de Grenoble - Hopital de la Tronche

    Grenoble, 38043

    Dominique Plantaz, MD, PhD, 33-476-76-5469, dominique.plantaz@ujf-grenoble.fr

    Recruiting

  • Hopital Saint Antoine Lille

    Lille, 59000

    Francois Dusol, MD, 33-20-78-31-31

    Recruiting

  • Centre Oscar Lambret

    Lille, 59020

    Marie C. Baranzelli, MD, 33-20-295-959

    Recruiting

  • Centre Hospitalier Regional et Universitaire de Lille

    Lille, 59037

    B. Nelken, MD, 33-320-444-263, bnelken@chru-lille.fr

    Recruiting

  • Centre Hospital Regional Universitaire de Limoges

    Limoges, 87042

    I. De Lumley, 00-33-5-55-05-61-23

    Recruiting

  • Centre Leon Berard

    Lyon, 69373

    Didier Frappaz, MD, 33-4-78-782881, frappa2@lyon.fnclcc.fr

    Recruiting

  • CHU de la Timone

    Marseille, 13385

    Carole Coze, 33-91-385-708

    Recruiting

  • Hopital Arnaud de Villeneuve

    Montpellier, 34295

    Genevieve Margueritte, MD, 33-67-33-6630, margueritte.g@wanadoo.fr

    Recruiting

  • Centre Antoine Lacassagne

    Nice, 06189

    Antoine Thyss, MD, 33-04-9203-1538, antoine.thyss@cal.nice.fnclcc.fr

    Recruiting

  • Institut Curie Hopital

    Paris, 75248

    Jean Marie Michon, MD, 33-1-44-324-558, jean.michon@curie.net

    Recruiting

  • Hopital Jean Bernard

    Poitiers, 86021

    Frederic Millot, MD, 33-05-49-444-201, f.millot@chu-poitiers.fr

    Recruiting

  • Hopital Americain

    Reims, 51092

    Catherine Behar, MD, 33-26-787-515

    Recruiting

  • Hopital Sud

    Rennes, 35056

    Christophe Bergeron, 33-02-9928-4321

    Recruiting

  • Hopital Charles Nicolle

    Rouen, 76031

    J.P. Vannier, 33-2-3288-89-90

    Recruiting

  • CHU Sainte-Etienne - Hopital Nord

    Saint-Étienne-d'Orthe, 42055

    J. Louis Stephan, 33-4-77-82-80-00

    Recruiting

  • Hopitaux Universitaire de Strasbourg

    Strasbourg, 67091

    Patrick Lutz, MD, 33-388-116-768 ext. 61010

    Recruiting

  • Centre Hospitalier Regional de Purpan

    Toulouse, 31026

    Herve Rubie, MD, 33-53-455-8611, rubie.h@chu-toulouse.fr

    Recruiting

  • C.H. Bastien de Clocheville

    Tours, 37044

    O. Lejars, 33-02-4747-4747

    Recruiting

  • CHRU de Tours - Hopital Trousseau

    Tours, 37044

    Guy Leverger, 33-2-4747-4603

    Recruiting

  • CHU de Nancy - Hopitaux de Brabois

    Vandœuvre-lès-Nancy, 54511

    Pascal Chastagner, 33-038-315-4621

    Recruiting

  • Institut Gustave Roussy

    Villejuif, F-94805

    Olivier Hartmann, 33-1-42-11-4211

    Recruiting

Other trials in France

United Kingdom18 sites, 18 recruiting

  • Aberdeen Royal Infirmary

    Aberdeen, Scotland, AB25 2ZN

    D.J. King, MD, 44-84-5456-6000, derek.king@arh.gampian.scot.nhs.uk

    Recruiting

  • Royal Belfast Hospital for Sick Children

    Belfast, Northern Ireland, BT12 6BE

    S.I. Dempsey, MD, 44-28-9063-2402

    Recruiting

  • Bristol Royal Hospital for Children

    Bristol, England, BS2 8BJ

    Annabel B.M. Foot, 44-117-342-8520

    Recruiting

  • Addenbrooke's Hospital

    Cambridge, England, CB2 2QQ

    V. Broadbent, 44-1223-245-151

    Recruiting

  • Royal Hospital for Sick Children

    Edinburgh, Scotland, EH9 1LF

    W. Hamish Wallace, MD, 44-131-536-0426

    Recruiting

  • Royal Hospital for Sick Children

    Glasgow, Scotland, G3 8SJ

    E.M. Simpson, 44-141-201-0000

    Recruiting

  • Leicester Royal Infirmary

    Leicester, England, LE1 5WW

    Rosemary S. Shannon, MD, 44-116-254-1414

    Recruiting

  • Royal Liverpool Children's Hospital, Alder Hey

    Liverpool, England, L12 2AP

    Heather P. McDowell, MD, 44-151-293-3679

    Recruiting

  • Llandough Hospital

    Llandough, Wales, CF64 2XX

    D. Webb, 44-029-2071-1711

    Recruiting

  • Great Ormond Street Hospital for Children

    London, England, WC1N 3JH

    Ian Malcolm Hann, MD, 44-20-7829-8831, Ian.Hann@gosh-tr.nthames.nhs.uk

    Recruiting

  • University College of London Hospitals

    London, England, WIT 3AA

    Robert L. Souhami, MD, FRCP, FRCR, 44-20-7636-8333

    Recruiting

  • Christie Hospital

    Manchester, England, M20 4BX

    H. R. Gattamaneni, MD, 44-161-446-3000

    Recruiting

  • Northern Centre for Cancer Treatment at Newcastle General Hospital

    Newcastle upon Tyne, England, NE4 6BE

    Andrew David J. Pearson, MD, FRCP, DCh, 44-191-273-8811 ext. 24101

    Recruiting

  • Queen's Medical Centre

    Nottingham, England, NG7 2UH

    David A. Walker, 44-115-924-9924 ext 61727, david.walker@nottingham.ac.uk

    Recruiting

  • Oxford Radcliffe Hospital

    Oxford, England, 0X3 9DU

    C. Mitchell, 44-1865-221-066

    Recruiting

  • Children's Hospital - Sheffield

    Sheffield, England, S10 2TH

    Mary P. Gerrard, MBChB, FRCP, FRCPCH, 44-114-271-7366, mary.gerrard@sch.nhs.uk

    Recruiting

  • Southampton General Hospital

    Southampton, England, SO16 6YD

    Janice A. Kohler, MD, FRCP, 44-23-8079-6942

    Recruiting

  • Royal Marsden - Surrey

    Sutton, England, SM2 5PT

    Charles Ross Pinkerton, MD, 44-20-8642-6011

    Recruiting

Other trials in United Kingdom

Spain14 sites, 14 recruiting

  • Hospital de la Santa Cruz i Sant Pau

    Barcelona, 08025

    Josep Cubells Riero, 34-93-291-9440

    Recruiting

  • Vall d'Hebron University Hospital

    Barcelona, 08035

    Jose M. Sanchez De Toledo, 34-93-274-6077

    Recruiting

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

    Maria Angeles Cantalejo, 34-91-586-8598

    Recruiting

  • Hospital Ramon y Cajal

    Madrid, 28034

    Arturo Munoz Villa, 34-91-336-8263

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Jesus Lopez Perez, 34-91-390-8000

    Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046

    Purificacion Garcia Miguel, 34-91-727-7000

    Recruiting

  • Hospital Regional Carlos Haya De Malaga

    Málaga, 29010

    Antonio Urda, 34-95-227-7400

    Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo, 33006

    Jesus Antuna, 34-98-510-6112

    Recruiting

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, 38320

    J. Rodriguez Luis, 34-92-267-8000

    Recruiting

  • Hospital General de Galicia

    Santiago de Compostela, 15705

    J. Miguel Couselo, 34-981-540-000

    Recruiting

  • Hospital Universitario La Fe

    Valencia, 46009

    Victoria Castel, 34-96-386-2700

    Recruiting

  • Complejo Hospitalario Xeral de Vigo

    Vigo Pontevedra, 36204

    Contact Person, 34-98-681-6000

    Recruiting

  • Hospital Des Cruces

    Vizcaya, 48

    Aurora Navajas, 34-94-600-6000

    Recruiting

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

    Carlota Calvo, 34-97-676-5510

    Recruiting

Other trials in Spain

Austria6 sites, 6 recruiting

  • Universitaet Kinderklinik

    Graz, 8036

    Christian Urban, 43-0316-385-2605

    Recruiting

  • Innsbruck Universitaetsklinik

    Innsbruck, A-6020

    Franz Martin Fink, 43-512-5042-2971

    Recruiting

  • Landeskrankenhaus Klagenfurt

    Klagenfurt, 9026

    Wilhelm Kaulfersch, 43-463-538-22-200

    Recruiting

  • LKH Leoben

    Leoben, A-8700

    Ingomar D. Mutz, MD, 43-3842-401 ext. 2330

    Recruiting

  • St. Johanns-Spital

    Salzburg, A-5020

    Heinz Griegenberg, 43-662-4482-2879

    Recruiting

  • Allgemeines Krankenhaus - Universitatskliniken

    Vienna, A-1090

    Konrad Pillwein, 43-1-40-400

    Recruiting

Other trials in Austria

Switzerland3 sites, 3 recruiting

  • Kantonsspital Aarau

    Aarau, CH-5001

    Paul A. Imbach, MD, 41-62-838-4913

    Recruiting

  • Hopital des Enfants

    Geneva, 1211

    Contact Person, 41-22-382-4568

    Recruiting

  • Ostschweizer Kinderspital

    Sankt Gallen, 9006

    Andreas J. Feldges, MD, 41-71-243-7381, andreas.feldges2@gd-kispi.sg

    Recruiting

Other trials in Switzerland

Netherlands2 sites, 2 recruiting

  • Academisch Medisch Centrum at University of Amsterdam

    Amsterdam, 1100 DE

    Jan DeKraker, MD, 31-20-566-9111, j.dekraker@amc.uva.nl

    Recruiting

  • University Medical Center Groningen

    Groningen, 9700 RB

    Willem A. Kamps, MD, PhD, 31-50-361-4213, w.a.kamps@bkk.umcg.nl

    Recruiting

Other trials in Netherlands

Ireland1 site, 1 recruiting

  • Our Lady's Hospital for Sick Children Crumlin

    Dublin, 12

    Fin Breatnach, MD, FRCPE, 353-1-409-6659, fin.breatnach@olhsc.ie

    Recruiting

Other trials in Ireland

About this study

Official title: Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma

RATIONALE: Surgery may be an effective treatment for neuroblastoma.

PURPOSE: This phase II trial is studying how well surgery works in treating patients with neuroblastoma.

Read the detailed description

OBJECTIVES:

  • Evaluate the safety and efficacy of surgical treatment alone for stage II neuroblastoma without N-myc amplification (NMA).
  • Describe predictive factors of relapse and survival for stages I and II neuroblastoma without NMA treated by surgery alone.

OUTLINE: Patients with localized resectable tumors undergo surgery. Postoperative evaluations are performed 30 days following surgery. Study patients with stage I (without N-myc amplification) tumors and trial patients with stage II tumors receive no further therapy.

Study patients (except stage I patients) receive surgery and/or chemotherapy according to other protocols as necessary for disease progression or relapse.

Patients are followed every 3 months for the first year, then every 4 and 6 months for the second and third year respectively, then yearly for 5 years.

PROJECTED ACCRUAL: This study will accrue 140 stage II patients for the trial portion at a rate of 40 per year over 3.5 years. At least 70 more patients will be accrued for the study portion.

Conditions
Neuroblastoma
Being tested
surgical procedure
Keywords
localized resectable neuroblastoma, localized unresectable neuroblastoma
Medical subject headings
Neuroblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • surgical procedureProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and efficacy

  2. Predictive factors of relapse and survival

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startDec 1994

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003122
Sponsor's protocol ID
CDR0000065880
Other IDs
SIOP-95-1, EU-96053
Status last verified
Jul 2007
First submitted
1 Nov 1999
Last updated
26 Aug 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing surgical procedure in people with Neuroblastoma, run by Societe Internationale d'Oncologie Pediatrique at 96 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 96 sites in Italy, France, United Kingdom, Spain, Austria and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and efficacy. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003122.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2013.

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