Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
210 participants
INTERVENTIONAL
1994-12-31
Brief Summary
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PURPOSE: This phase II trial is studying how well surgery works in treating patients with neuroblastoma.
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Detailed Description
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* 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
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Study Design
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TREATMENT
Interventions
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surgical procedure
Eligibility Criteria
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Inclusion Criteria
* 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
20 Years
ALL
No
Sponsors
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Societe Internationale d'Oncologie Pediatrique
OTHER
Principal Investigators
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Jean Marie Michon, MD
Role: STUDY_CHAIR
Institut Curie
Locations
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Universitaet Kinderklinik
Graz, , Austria
Innsbruck Universitaetsklinik
Innsbruck, , Austria
Landeskrankenhaus Klagenfurt
Klagenfurt, , Austria
LKH Leoben
Leoben, , Austria
St. Johanns-Spital
Salzburg, , Austria
Allgemeines Krankenhaus - Universitatskliniken
Vienna, , Austria
CHR de Besancon - Hopital Saint-Jacques
Besançon, , France
CHU de Caen
Caen, , France
CHR Clermont Ferrand, Hotel Dieu
Clermont-Ferrand, , France
Centre Hospitalier Universitaire de Dijon
Dijon, , France
CHU de Grenoble - Hopital de la Tronche
Grenoble, , France
Hopital Saint Antoine Lille
Lille, , France
Centre Oscar Lambret
Lille, , France
Centre Hospitalier Regional et Universitaire de Lille
Lille, , France
Centre Hospital Regional Universitaire de Limoges
Limoges, , France
Centre Leon Berard
Lyon, , France
CHU de la Timone
Marseille, , France
Hopital Arnaud de Villeneuve
Montpellier, , France
Centre Antoine Lacassagne
Nice, , France
Institut Curie Hopital
Paris, , France
Hopital Jean Bernard
Poitiers, , France
Hopital Americain
Reims, , France
Hopital Sud
Rennes, , France
Hopital Charles Nicolle
Rouen, , France
CHU Sainte-Etienne - Hopital Nord
Saint-Étienne-d'Orthe, , France
Hopitaux Universitaire de Strasbourg
Strasbourg, , France
Centre Hospitalier Regional de Purpan
Toulouse, , France
C.H. Bastien de Clocheville
Tours, , France
CHRU de Tours - Hopital Trousseau
Tours, , France
CHU de Nancy - Hopitaux de Brabois
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy
Villejuif, , France
Our Lady's Hospital for Sick Children Crumlin
Dublin, , Ireland
Universita Degli Studi di Bari
Bari, , Italy
Ospedali Riuniti di Bergamo
Bergamo, , Italy
Spedali Civili di Brescia
Brescia, , Italy
Ospedale Oncologico A. Businco
Cagliari, , Italy
Policlinico Dell'Universita
Catania, , Italy
Ospedale Galliera
Genoa, , Italy
Istituto Giannina Gaslini
Genoa, , Italy
Istituti Clinici di Perfezionamento
Milan, , Italy
Fondazione Istituto Nazionale dei Tumori
Milan, , Italy
Ospedale Niguarda Ca'Granda
Milan, , Italy
Azienda Ospedaliera - Universitaria di Modena
Modena, , Italy
Ospedale S.S. Annunziata Napoli
Naples, , Italy
Federico II University Medical School
Naples, , Italy
Clinica Pediatrica I
Naplesi, , Italy
Azienda Ospedaliera di Padova
Padua, , Italy
Clinica Pediatrica Palermo
Palermo, , Italy
Azienda Ospedaliera Di Parma
Parma, , Italy
Fondazione I.R.C.C.S. Policlinico San Matteo
Pavia, , Italy
Ospedale Silvestrini
Perugia, , Italy
Ospedale Santa Chiara Pisa
Pisa, , Italy
Azienda Policlinico Umberto Primo
Rome, , Italy
Ospedale Bambino Gesu
Rome, , Italy
Clinica Ars Medica
Rome, , Italy
Istituto Clinica Medica
Sassari, , Italy
University of Siena
Siena, , Italy
Clinica Pediatrica Trieste
Trieste, , Italy
Ospedale Infantile Regina Margherita
Turin, , Italy
Academisch Medisch Centrum at University of Amsterdam
Amsterdam, , Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Hospital de la Santa Cruz i Sant Pau
Barcelona, , Spain
Vall d'Hebron University Hospital
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Ramon y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Regional Carlos Haya De Malaga
Málaga, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, , Spain
Hospital General de Galicia
Santiago de Compostela, , Spain
Hospital Universitario La Fe
Valencia, , Spain
Complejo Hospitalario Xeral de Vigo
Vigo Pontevedra, , Spain
Hospital Des Cruces
Vizcaya, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Kantonsspital Aarau
Aarau, , Switzerland
Hopital des Enfants
Geneva, , Switzerland
Ostschweizer Kinderspital
Sankt Gallen, , Switzerland
Bristol Royal Hospital for Children
Bristol, England, United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom
Great Ormond Street Hospital for Children
London, England, United Kingdom
University College of London Hospitals
London, England, United Kingdom
Christie Hospital
Manchester, England, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle upon Tyne, England, United Kingdom
Queen's Medical Centre
Nottingham, England, United Kingdom
Oxford Radcliffe Hospital
Oxford, England, United Kingdom
Children's Hospital - Sheffield
Sheffield, England, United Kingdom
Southampton General Hospital
Southampton, England, United Kingdom
Royal Marsden - Surrey
Sutton, England, United Kingdom
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom
Llandough Hospital
Llandough, Wales, United Kingdom
Countries
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Facility Contacts
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Christian Urban
Role: primary
Franz Martin Fink
Role: primary
Wilhelm Kaulfersch
Role: primary
Ingomar D. Mutz, MD
Role: primary
Heinz Griegenberg
Role: primary
Konrad Pillwein
Role: primary
F. Demeocq
Role: primary
G. Couillault
Role: primary
Francois Dusol, MD
Role: primary
Marie C. Baranzelli, MD
Role: primary
I. De Lumley
Role: primary
Carole Coze
Role: primary
Catherine Behar, MD
Role: primary
Christophe Bergeron
Role: primary
J.P. Vannier
Role: primary
J. Louis Stephan
Role: primary
Patrick Lutz, MD
Role: primary
O. Lejars
Role: primary
Guy Leverger
Role: primary
Pascal Chastagner
Role: primary
Olivier Hartmann
Role: primary
Serenella Bagnulo
Role: primary
Piermemilio Cornelli
Role: primary
Alberto Arrighini
Role: primary
Roberto Targhetta
Role: primary
Gino Schilliro
Role: primary
Marco Cominetti
Role: primary
Maria Fagnani
Role: primary
Marco Gasparini, MD
Role: primary
Alvaro Moreno
Role: primary
Fausto Massolo
Role: primary
Antonio Correra
Role: primary
Amadeo Fiorillo
Role: primary
Maria Teresa Di Tullio
Role: primary
Margherita Lo Curto
Role: primary
Giancarlo Izzi
Role: primary
Frederico Bonetti
Role: primary
Paolo Zucchetti
Role: primary
Claudio Favre
Role: primary
Manuel A. Castello
Role: primary
Alberto Donfrancesco
Role: primary
Antonia Mancini
Role: primary
Domenico Gallisai
Role: primary
Antonio Acquaviva
Role: primary
Paolo Tamaro
Role: primary
Luca Cordero Di Montezemolo
Role: primary
Josep Cubells Riero
Role: primary
Jose M. Sanchez De Toledo
Role: primary
Maria Angeles Cantalejo
Role: primary
Arturo Munoz Villa
Role: primary
Jesus Lopez Perez
Role: primary
Purificacion Garcia Miguel
Role: primary
Antonio Urda
Role: primary
Jesus Antuna
Role: primary
J. Rodriguez Luis
Role: primary
J. Miguel Couselo
Role: primary
Victoria Castel
Role: primary
Contact Person
Role: primary
Aurora Navajas
Role: primary
Carlota Calvo
Role: primary
Paul A. Imbach, MD
Role: primary
Contact Person
Role: primary
Annabel B.M. Foot
Role: primary
V. Broadbent
Role: primary
Rosemary S. Shannon, MD
Role: primary
Heather P. McDowell, MD
Role: primary
Robert L. Souhami, MD, FRCP, FRCR
Role: primary
H. R. Gattamaneni, MD
Role: primary
Andrew David J. Pearson, MD, FRCP, DCh
Role: primary
C. Mitchell
Role: primary
Janice A. Kohler, MD, FRCP
Role: primary
Charles Ross Pinkerton, MD
Role: primary
S.I. Dempsey, MD
Role: primary
W. Hamish Wallace, MD
Role: primary
E.M. Simpson
Role: primary
D. Webb
Role: primary
Other Identifiers
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SIOP-95-1
Identifier Type: -
Identifier Source: secondary_id
EU-96053
Identifier Type: -
Identifier Source: secondary_id
CDR0000065880
Identifier Type: -
Identifier Source: org_study_id
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