Surgery in Treating Patients With Neuroblastoma

August 23, 2013 updated by: Societe Internationale d'Oncologie Pediatrique

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

210

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Recruiting
        • Universitaet Kinderklinik
        • Contact:
          • Christian Urban
          • Phone Number: 43-0316-385-2605
      • Innsbruck, Austria, A-6020
        • Recruiting
        • Innsbruck Universitaetsklinik
        • Contact:
          • Franz Martin Fink
          • Phone Number: 43-512-5042-2971
      • Klagenfurt, Austria, 9026
        • Recruiting
        • Landeskrankenhaus Klagenfurt
        • Contact:
          • Wilhelm Kaulfersch
          • Phone Number: 43-463-538-22-200
      • Leoben, Austria, A-8700
        • Recruiting
        • LKH Leoben
        • Contact:
          • Ingomar D. Mutz, MD
          • Phone Number: 43-3842-401 ext. 2330
      • Salzburg, Austria, A-5020
        • Recruiting
        • St. Johanns-Spital
        • Contact:
          • Heinz Griegenberg
          • Phone Number: 43-662-4482-2879
      • Vienna, Austria, A-1090
        • Recruiting
        • Allgemeines Krankenhaus - Universitatskliniken
        • Contact:
          • Konrad Pillwein
          • Phone Number: 43-1-40-400
  • France
      • Besancon, France, 25030
        • Recruiting
        • CHR de Besancon - Hopital Saint-Jacques
        • Contact:
      • Caen, France, 14033
        • Recruiting
        • CHU de Caen
        • Contact:
      • Clermont-Ferrand, France, 63058
        • Recruiting
        • CHR Clermont Ferrand, Hotel Dieu
        • Contact:
          • F. Demeocq
          • Phone Number: 33-73-316-000
      • Dijon, France, 21079
        • Recruiting
        • Centre Hospitalier Universitaire de Dijon
        • Contact:
          • G. Couillault
          • Phone Number: 33-380-293-031
      • Grenoble, France, 38043
      • Lille, France, 59020
        • Recruiting
        • Centre Oscar Lambret
        • Contact:
          • Marie C. Baranzelli, MD
          • Phone Number: 33-20-295-959
      • Lille, France, 59000
        • Recruiting
        • Hopital Saint Antoine Lille
        • Contact:
          • Francois Dusol, MD
          • Phone Number: 33-20-78-31-31
      • Lille, France, 59037
        • Recruiting
        • Centre Hospitalier Regional et Universitaire de Lille
        • Contact:
      • Limoges, France, 87042
        • Recruiting
        • Centre Hospital Regional Universitaire de Limoges
        • Contact:
          • I. De Lumley
          • Phone Number: 00-33-5-55-05-61-23
      • Lyon, France, 69373
        • Recruiting
        • Centre Léon Bérard
        • Contact:
      • Marseille, France, 13385
        • Recruiting
        • CHU de la Timone
        • Contact:
          • Carole Coze
          • Phone Number: 33-91-385-708
      • Montpellier, France, 34295
        • Recruiting
        • Hôpital Arnaud de Villeneuve
        • Contact:
      • Nice, France, 06189
      • Paris, France, 75248
        • Recruiting
        • Institut Curie Hopital
        • Contact:
      • Poitiers, France, 86021
        • Recruiting
        • Hopital Jean Bernard
        • Contact:
      • Reims, France, 51092
        • Recruiting
        • Hôpital Américain
        • Contact:
          • Catherine Behar, MD
          • Phone Number: 33-26-787-515
      • Rennes, France, 35056
        • Recruiting
        • Hopital Sud
        • Contact:
          • Christophe Bergeron
          • Phone Number: 33-02-9928-4321
      • Rouen, France, 76031
        • Recruiting
        • Hopital Charles Nicolle
        • Contact:
          • J.P. Vannier
          • Phone Number: 33-2-3288-89-90
      • Sainte-Etienne, France, 42055
        • Recruiting
        • CHU Sainte-Etienne - Hopital Nord
        • Contact:
          • J. Louis Stephan
          • Phone Number: 33-4-77-82-80-00
      • Strasbourg, France, 67091
        • Recruiting
        • Hopitaux Universitaire de Strasbourg
        • Contact:
          • Patrick Lutz, MD
          • Phone Number: 33-388-116-768 ext. 61010
      • Toulouse, France, 31026
        • Recruiting
        • Centre Hospitalier Regional de Purpan
        • Contact:
      • Tours, France, 37044
        • Recruiting
        • C.H. Bastien de Clocheville
        • Contact:
          • O. Lejars
          • Phone Number: 33-02-4747-4747
      • Tours, France, 37044
        • Recruiting
        • CHRU de Tours - Hopital Trousseau
        • Contact:
          • Guy Leverger
          • Phone Number: 33-2-4747-4603
      • Vandoeuvre-Les-Nancy, France, 54511
        • Recruiting
        • CHU de Nancy - Hopitaux de Brabois
        • Contact:
          • Pascal Chastagner
          • Phone Number: 33-038-315-4621
      • Villejuif, France, F-94805
        • Recruiting
        • Institut Gustave Roussy
        • Contact:
          • Olivier Hartmann
          • Phone Number: 33-1-42-11-4211
  • Ireland
      • Dublin, Ireland, 12
        • Recruiting
        • Our Lady's Hospital for Sick Children Crumlin
  • Italy
      • Bari, Italy, 70124
        • Recruiting
        • Università degli Studi di Bari
        • Contact:
          • Serenella Bagnulo
          • Phone Number: 39-080-5478-660
      • Bergamo, Italy, 24100
        • Recruiting
        • Ospedali Riuniti di Bergamo
        • Contact:
          • Piermemilio Cornelli
          • Phone Number: 39-035-269-859
      • Brescia, Italy, 25123
        • Recruiting
        • Spedali Civili di Brescia
        • Contact:
          • Alberto Arrighini
          • Phone Number: 39-030-395-823
      • Cagliari, Italy, 09121
        • Recruiting
        • Ospedale Oncologico A. Businco
        • Contact:
          • Roberto Targhetta
          • Phone Number: 39-070-609-5204
      • Catania, Italy, 95125
        • Recruiting
        • Policlinico Dell'Universita
        • Contact:
          • Gino Schilliro
          • Phone Number: 39-095-330-533
      • Genoa, Italy, 16128
        • Recruiting
        • Ospedale Galliera
        • Contact:
          • Marco Cominetti
          • Phone Number: 39-010-56-321
      • Genoa, Italy, 16148
      • Milan, Italy, 20133
        • Recruiting
        • Fondazione Istituto Nazionale dei Tumori
        • Contact:
          • Marco Gasparini, MD
          • Phone Number: 02-2390587
      • Milan, Italy, 20122
        • Recruiting
        • Istituti Clinici di Perfezionamento
        • Contact:
          • Maria Fagnani
          • Phone Number: 39-2-5799-1
      • Milan, Italy, 20162
        • Recruiting
        • Ospedale Niguarda Ca'Granda
        • Contact:
          • Alvaro Moreno
          • Phone Number: 39-02-6444-2291
      • Modena, Italy, 41100
        • Recruiting
        • Azienda Ospedaliera - Universitaria di Modena
        • Contact:
          • Fausto Massolo
          • Phone Number: 39-059-422-4373
      • Naples, Italy, 80131
        • Recruiting
        • Federico II University Medical School
        • Contact:
          • Amadeo Fiorillo
          • Phone Number: 39-081-746-3772
      • Naples, Italy, 80100
        • Recruiting
        • Ospedale S.S. Annunziata Napoli
        • Contact:
          • Antonio Correra
          • Phone Number: 39-081-254-2588
      • Naplesi, Italy, 480138
        • Recruiting
        • Clinica Pediatrica I
        • Contact:
          • Maria Teresa Di Tullio
          • Phone Number: 39-081-445-255
      • Padova, Italy, 35128
        • Recruiting
        • Azienda Ospedaliera di Padova
        • Contact:
      • Palermo, Italy, 90134
        • Recruiting
        • Clinica Pediatrica Palermo
        • Contact:
          • Margherita Lo Curto
          • Phone Number: 39-091-485-292
      • Parma, Italy, 43100
        • Recruiting
        • Azienda Ospedaliera Di Parma
        • Contact:
          • Giancarlo Izzi
          • Phone Number: 39-521-702-441
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione I.R.C.C.S. Policlinico San Matteo
        • Contact:
          • Frederico Bonetti
          • Phone Number: 39-0382-502-580
      • Perugia, Italy, 06132
        • Recruiting
        • Ospedale Silvestrini
        • Contact:
          • Paolo Zucchetti
          • Phone Number: 39-075-578-3392
      • Pisa, Italy, 56100
        • Recruiting
        • Ospedale Santa Chiara Pisa
        • Contact:
          • Claudio Favre
          • Phone Number: 39-50-992-540
      • Rome, Italy, 00161
        • Recruiting
        • Azienda Policlinico Umberto Primo
        • Contact:
          • Manuel A. Castello
          • Phone Number: 39-06-857-951
      • Rome, Italy, 00165
        • Recruiting
        • Ospedale Bambino Gesu
        • Contact:
          • Alberto Donfrancesco
          • Phone Number: 39-06-6859-2351
      • Rome, Italy, 00191
        • Recruiting
        • Clinica Ars Medica
        • Contact:
          • Antonia Mancini
          • Phone Number: 39-06-3620-8502
      • Sassari, Italy, 07100
        • Recruiting
        • Istituto Clinica Medica
        • Contact:
          • Domenico Gallisai
          • Phone Number: 39-079-228-382
      • Siena, Italy, 53100
        • Recruiting
        • University of Siena
        • Contact:
          • Antonio Acquaviva
          • Phone Number: 39-0577-280-921
      • Trieste, Italy
        • Recruiting
        • Clinica Pediatrica Trieste
        • Contact:
          • Paolo Tamaro
          • Phone Number: 39-040-378-5380
      • Turin, Italy, 10126
        • Recruiting
        • Ospedale Infantile Regina Margherita
        • Contact:
          • Luca Cordero Di Montezemolo
          • Phone Number: 39-011-692-7230
  • Netherlands
      • Amsterdam, Netherlands, 1100 DE
        • Recruiting
        • Academisch Medisch Centrum at University of Amsterdam
        • Contact:
      • Groningen, Netherlands, 9700 RB
        • Recruiting
        • University Medical Center Groningen
        • Contact:
  • Spain
      • Barcelona, Spain, 08025
        • Recruiting
        • Hospital de la Santa Cruz i Sant Pau
        • Contact:
          • Josep Cubells Riero
          • Phone Number: 34-93-291-9440
      • Barcelona, Spain, 08035
        • Recruiting
        • Vall D'Hebron University Hospital
        • Contact:
          • Jose M. Sanchez De Toledo
          • Phone Number: 34-93-274-6077
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
          • Jesus Lopez Perez
          • Phone Number: 34-91-390-8000
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:
          • Purificacion Garcia Miguel
          • Phone Number: 34-91-727-7000
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Marañon
        • Contact:
          • Maria Angeles Cantalejo
          • Phone Number: 34-91-586-8598
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Ramon y Cajal
        • Contact:
          • Arturo Munoz Villa
          • Phone Number: 34-91-336-8263
      • Malaga, Spain, 29010
        • Recruiting
        • Hospital Regional Carlos Haya De Malaga
        • Contact:
          • Antonio Urda
          • Phone Number: 34-95-227-7400
      • Oviedo, Spain, 33006
        • Recruiting
        • Hospital Universitario Central de Asturias
        • Contact:
          • Jesus Antuna
          • Phone Number: 34-98-510-6112
      • San Cristobal de La Laguna, Spain, 38320
        • Recruiting
        • Hospital Universitario de Canarias
        • Contact:
          • J. Rodriguez Luis
          • Phone Number: 34-92-267-8000
      • Santiago de Compostela, Spain, 15705
        • Recruiting
        • Hospital General de Galicia
        • Contact:
          • J. Miguel Couselo
          • Phone Number: 34-981-540-000
      • Valencia, Spain, 46009
        • Recruiting
        • Hospital Universitario La Fe
        • Contact:
          • Victoria Castel
          • Phone Number: 34-96-386-2700
      • Vigo Pontevedra, Spain, 36204
        • Recruiting
        • Complejo Hospitalario Xeral de Vigo
        • Contact:
          • Contact Person
          • Phone Number: 34-98-681-6000
      • Vizcaya, Spain, 48
        • Recruiting
        • Hospital Des Cruces
        • Contact:
          • Aurora Navajas
          • Phone Number: 34-94-600-6000
      • Zaragoza, Spain, 50009
        • Recruiting
        • Hospital Universitario Miguel Servet
        • Contact:
          • Carlota Calvo
          • Phone Number: 34-97-676-5510
  • Switzerland
      • Aarau, Switzerland, CH-5001
        • Recruiting
        • Kantonsspital Aarau
        • Contact:
          • Paul A. Imbach, MD
          • Phone Number: 41-62-838-4913
      • Geneva, Switzerland, 1211
        • Recruiting
        • Hopital des Enfants
        • Contact:
          • Contact Person
          • Phone Number: 41-22-382-4568
      • St. Gallen, Switzerland, 9006
  • United Kingdom
    • England
      • Bristol, England, United Kingdom, BS2 8BJ
        • Recruiting
        • Bristol Royal Hospital for Children
        • Contact:
          • Annabel B.M. Foot
          • Phone Number: 44-117-342-8520
      • Cambridge, England, United Kingdom, CB2 2QQ
        • Recruiting
        • Addenbrooke's Hospital
        • Contact:
          • V. Broadbent
          • Phone Number: 44-1223-245-151
      • Leicester, England, United Kingdom, LE1 5WW
        • Recruiting
        • Leicester Royal Infirmary
        • Contact:
          • Rosemary S. Shannon, MD
          • Phone Number: 44-116-254-1414
      • Liverpool, England, United Kingdom, L12 2AP
        • Recruiting
        • Royal Liverpool Children's Hospital, Alder Hey
      • London, England, United Kingdom, WC1N 3JH
      • London, England, United Kingdom, WIT 3AA
        • Recruiting
        • University College of London Hospitals
        • Contact:
          • Robert L. Souhami, MD, FRCP, FRCR
          • Phone Number: 44-20-7636-8333
      • Manchester, England, United Kingdom, M20 4BX
        • Recruiting
        • Christie Hospital
        • Contact:
          • H. R. Gattamaneni, MD
          • Phone Number: 44-161-446-3000
      • Newcastle Upon Tyne, England, United Kingdom, NE4 6BE
        • Recruiting
        • Northern Centre for Cancer Treatment at Newcastle General Hospital
        • Contact:
          • Andrew David J. Pearson, MD, FRCP, DCh
          • Phone Number: 44-191-273-8811 ext. 24101
      • Nottingham, England, United Kingdom, NG7 2UH
      • Oxford, England, United Kingdom, 0X3 9DU
        • Recruiting
        • Oxford Radcliffe Hospital
        • Contact:
          • C. Mitchell
          • Phone Number: 44-1865-221-066
      • Sheffield, England, United Kingdom, S10 2TH
        • Recruiting
        • Children's Hospital - Sheffield
      • Southampton, England, United Kingdom, SO16 6YD
        • Recruiting
        • Southampton General Hospital
      • Sutton, England, United Kingdom, SM2 5PT
        • Recruiting
        • Royal Marsden - Surrey
        • Contact:
          • Charles Ross Pinkerton, MD
          • Phone Number: 44-20-8642-6011
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT12 6BE
        • Recruiting
        • Royal Belfast Hospital for Sick Children
        • Contact:
          • S.I. Dempsey, MD
          • Phone Number: 44-28-9063-2402
    • Scotland
      • Aberdeen, Scotland, United Kingdom, AB25 2ZN
      • Edinburgh, Scotland, United Kingdom, EH9 1LF
        • Recruiting
        • Royal Hospital for Sick Children
      • Glasgow, Scotland, United Kingdom, G3 8SJ
        • Recruiting
        • Royal Hospital for Sick Children
        • Contact:
          • E.M. Simpson
          • Phone Number: 44-141-201-0000
    • Wales
      • Llandough, Wales, United Kingdom, CF64 2XX
        • Recruiting
        • LLandough Hospital
        • Contact:
          • D. Webb
          • Phone Number: 44-029-2071-1711

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 20 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety and efficacy
Predictive factors of relapse and survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Societe Internationale d'Oncologie Pediatrique

Investigators

  • Study Chair: Jean Marie Michon, MD, Institut Curie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1994

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (ESTIMATE)

January 27, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

August 26, 2013

Last Update Submitted That Met QC Criteria

August 23, 2013

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000065880
  • SIOP-95-1
  • EU-96053

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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