Surgery in Treating Patients With Neuroblastoma
- Conditions
- Neuroblastoma
- Registration Number
- NCT00003122
- Lead Sponsor
- Societe Internationale d'Oncologie Pediatrique
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 210
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Predictive factors of relapse and survival Safety and efficacy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (95)
Ospedale Galliera
🇮🇹Genoa, Italy
Ospedale Bambino Gesu
🇮🇹Rome, Italy
Academisch Medisch Centrum at University of Amsterdam
🇳🇱Amsterdam, Netherlands
Universitaet Kinderklinik
🇦🇹Graz, Austria
CHU de Caen
🇫🇷Caen, France
Hopital Saint Antoine Lille
🇫🇷Lille, France
Spedali Civili di Brescia
🇮🇹Brescia, Italy
Policlinico Dell'Universita
🇮🇹Catania, Italy
Institut Gustave Roussy
🇫🇷Villejuif, France
CHU de Nancy - Hopitaux de Brabois
🇫🇷Vandoeuvre-Les-Nancy, France
Ospedale Niguarda Ca'Granda
🇮🇹Milan, Italy
Ospedali Riuniti di Bergamo
🇮🇹Bergamo, Italy
Federico II University Medical School
🇮🇹Naples, Italy
Vall d'Hebron University Hospital
🇪🇸Barcelona, Spain
University of Siena
🇮🇹Siena, Italy
Clinica Pediatrica Trieste
🇮🇹Trieste, Italy
Hospital Ramon y Cajal
🇪🇸Madrid, Spain
Hospital de la Santa Cruz i Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Regional Carlos Haya De Malaga
🇪🇸Malaga, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Spain
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital General de Galicia
🇪🇸Santiago de Compostela, Spain
Kantonsspital Aarau
🇨🇭Aarau, Switzerland
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Complejo Hospitalario Xeral de Vigo
🇪🇸Vigo Pontevedra, Spain
Hospital Des Cruces
🇪🇸Vizcaya, Spain
Royal Belfast Hospital for Sick Children
🇬🇧Belfast, Northern Ireland, United Kingdom
Hopital des Enfants
🇨🇭Geneva, Switzerland
Ostschweizer Kinderspital
🇨🇭St. Gallen, Switzerland
Addenbrooke's Hospital
🇬🇧Cambridge, England, United Kingdom
Royal Marsden - Surrey
🇬🇧Sutton, England, United Kingdom
Royal Hospital for Sick Children
🇬🇧Glasgow, Scotland, United Kingdom
Hopital Jean Bernard
🇫🇷Poitiers, France
Centre Hospital Regional Universitaire de Limoges
🇫🇷Limoges, France
Centre Leon Berard
🇫🇷Lyon, France
CHU de la Timone
🇫🇷Marseille, France
Hospital Universitario de Canarias
🇪🇸San Cristobal de La Laguna, Spain
Hospital Universitario La Fe
🇪🇸Valencia, Spain
Allgemeines Krankenhaus - Universitatskliniken
🇦🇹Vienna, Austria
CHR de Besancon - Hopital Saint-Jacques
🇫🇷Besancon, France
CHR Clermont Ferrand, Hotel Dieu
🇫🇷Clermont-Ferrand, France
CHU de Grenoble - Hopital de la Tronche
🇫🇷Grenoble, France
Centre Hospitalier Universitaire de Dijon
🇫🇷Dijon, France
Centre Hospitalier Regional et Universitaire de Lille
🇫🇷Lille, France
Centre Oscar Lambret
🇫🇷Lille, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Hopital Arnaud de Villeneuve
🇫🇷Montpellier, France
Hopital Sud
🇫🇷Rennes, France
Institut Curie Hopital
🇫🇷Paris, France
Hopital Charles Nicolle
🇫🇷Rouen, France
Hopital Americain
🇫🇷Reims, France
CHU Sainte-Etienne - Hopital Nord
🇫🇷Sainte-Etienne, France
Hopitaux Universitaire de Strasbourg
🇫🇷Strasbourg, France
CHRU de Tours - Hopital Trousseau
🇫🇷Tours, France
Centre Hospitalier Regional de Purpan
🇫🇷Toulouse, France
C.H. Bastien de Clocheville
🇫🇷Tours, France
Our Lady's Hospital for Sick Children Crumlin
🇮🇪Dublin, Ireland
Universita Degli Studi di Bari
🇮🇹Bari, Italy
Ospedale Oncologico A. Businco
🇮🇹Cagliari, Italy
Istituto Giannina Gaslini
🇮🇹Genoa, Italy
Fondazione Istituto Nazionale dei Tumori
🇮🇹Milan, Italy
Istituti Clinici di Perfezionamento
🇮🇹Milan, Italy
Azienda Ospedaliera - Universitaria di Modena
🇮🇹Modena, Italy
Clinica Pediatrica Palermo
🇮🇹Palermo, Italy
Clinica Pediatrica I
🇮🇹Naplesi, Italy
Ospedale S.S. Annunziata Napoli
🇮🇹Naples, Italy
Azienda Ospedaliera di Padova
🇮🇹Padova, Italy
Fondazione I.R.C.C.S. Policlinico San Matteo
🇮🇹Pavia, Italy
Azienda Policlinico Umberto Primo
🇮🇹Rome, Italy
Azienda Ospedaliera Di Parma
🇮🇹Parma, Italy
Ospedale Silvestrini
🇮🇹Perugia, Italy
Ospedale Santa Chiara Pisa
🇮🇹Pisa, Italy
Clinica Ars Medica
🇮🇹Rome, Italy
Ospedale Infantile Regina Margherita
🇮🇹Turin, Italy
Istituto Clinica Medica
🇮🇹Sassari, Italy
Oxford Radcliffe Hospital
🇬🇧Oxford, England, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, England, United Kingdom
University College of London Hospitals
🇬🇧London, England, United Kingdom
Children's Hospital - Sheffield
🇬🇧Sheffield, England, United Kingdom
Christie Hospital
🇬🇧Manchester, England, United Kingdom
Llandough Hospital
🇬🇧Llandough, Wales, United Kingdom
St. Johanns-Spital
🇦🇹Salzburg, Austria
Queen's Medical Centre
🇬🇧Nottingham, England, United Kingdom
Bristol Royal Hospital for Children
🇬🇧Bristol, England, United Kingdom
Landeskrankenhaus Klagenfurt
🇦🇹Klagenfurt, Austria
LKH Leoben
🇦🇹Leoben, Austria
Royal Liverpool Children's Hospital, Alder Hey
🇬🇧Liverpool, England, United Kingdom
Innsbruck Universitaetsklinik
🇦🇹Innsbruck, Austria
Great Ormond Street Hospital for Children
🇬🇧London, England, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital
🇬🇧Newcastle Upon Tyne, England, United Kingdom
Southampton General Hospital
🇬🇧Southampton, England, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, Scotland, United Kingdom