Spots Global Cancer Trial Database for Surgery in Treating Patients With Neuroblastoma
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Trial Identification
Brief Title: Surgery in Treating Patients With Neuroblastoma
Official Title: Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma
Study ID: NCT00003122
Conditions
Interventions
Study Description
Brief 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.
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.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Besancon, , 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, Sainte-Etienne, , 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, Vandoeuvre-Les-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
Clinica Pediatrica I, Naplesi, , Italy
Ospedale S.S. Annunziata Napoli, Naples, , Italy
Federico II University Medical School, Naples, , Italy
Azienda Ospedaliera di Padova, Padova, , 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, Malaga, , Spain
Hospital Universitario Central de Asturias, Oviedo, , Spain
Hospital Universitario de Canarias, San Cristobal 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, St. 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
Contact Details
Name: Jean Marie Michon, MD
Affiliation: Institut Curie
Role: STUDY_CHAIR
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