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| Sponsor: | Societe Internationale d'Oncologie Pediatrique |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003122 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuroblastoma |
Procedure: surgical procedure |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma |
| Estimated Enrollment: | 210 |
| Study Start Date: | December 1994 |
OBJECTIVES:
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| Ages Eligible for Study: | up to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Study: Histologically proven neuroblastoma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations
Hide Study Locations| Austria | |
| Allgemeines Krankenhaus - Universitatskliniken | Recruiting |
| Vienna, Austria, A-1090 | |
| Contact: Konrad Pillwein 43-1-40-400 | |
| Innsbruck Universitaetsklinik | Recruiting |
| Innsbruck, Austria, A-6020 | |
| Contact: Franz Martin Fink 43-512-5042-2971 | |
| Landeskrankenhaus Klagenfurt | Recruiting |
| Klagenfurt, Austria, 9026 | |
| Contact: Wilhelm Kaulfersch 43-463-538-22-200 | |
| Universitaet Kinderklinik | Recruiting |
| Graz, Austria, 8036 | |
| Contact: Christian Urban 43-0316-385-2605 | |
| St. Johanns-Spital | Recruiting |
| Salzburg, Austria, A-5020 | |
| Contact: Heinz Griegenberg 43-662-4482-2879 | |
| LKH Leoben | Recruiting |
| Leoben, Austria, A-8700 | |
| Contact: Ingomar D. Mutz, MD 43-3842-401 ext. 2330 | |
| France | |
| C.H. Bastien de Clocheville | Recruiting |
| Tours, France, 37044 | |
| Contact: O. Lejars 33-02-4747-4747 | |
| Centre Antoine Lacassagne | Recruiting |
| Nice, France, 06189 | |
| Contact: Antoine Thyss, MD 33-04-9203-1538 antoine.thyss@cal.nice.fnclcc.fr | |
| Centre Hospital Regional Universitaire de Limoges | Recruiting |
| Limoges, France, 87042 | |
| Contact: I. De Lumley 00-33-5-55-05-61-23 | |
| Centre Hospitalier Regional de Purpan | Recruiting |
| Toulouse, France, 31026 | |
| Contact: Herve Rubie, MD 33-53-455-8611 rubie.h@chu-toulouse.fr | |
| Centre Hospitalier Regional et Universitaire de Lille | Recruiting |
| Lille, France, 59037 | |
| Contact: B. Nelken, MD 33-320-444-263 bnelken@chru-lille.fr | |
| Centre Hospitalier Universitaire de Dijon | Recruiting |
| Dijon, France, 21079 | |
| Contact: G. Couillault 33-380-293-031 | |
| Hopital Arnaud de Villeneuve | Recruiting |
| Montpellier, France, 34295 | |
| Contact: Genevieve Margueritte, MD 33-67-33-6630 margueritte.g@wanadoo.fr | |
| Centre Oscar Lambret | Recruiting |
| Lille, France, 59020 | |
| Contact: Marie C. Baranzelli, MD 33-20-295-959 | |
| CHR Clermont Ferrand, Hotel Dieu | Recruiting |
| Clermont-Ferrand, France, 63058 | |
| Contact: F. Demeocq 33-73-316-000 | |
| CHR de Besancon - Hopital Saint-Jacques | Recruiting |
| Besancon, France, 25030 | |
| Contact: Emmanuel Plouvier, MD 33-381-218-140 eplouvier@chu-besancon.fr | |
| CHRU de Tours - Hopital Trousseau | Recruiting |
| Tours, France, 37044 | |
| Contact: Guy Leverger 33-2-4747-4603 | |
| CHU de Caen | Recruiting |
| Caen, France, 14033 | |
| Contact: Patrick Boutard, MD 33-231-064-488 boutard_p@chu-caen.fr | |
| CHU de Grenoble - Hopital de la Tronche | Recruiting |
| Grenoble, France, 38043 | |
| Contact: Dominique Plantaz, MD, PhD 33-476-76-5469 dominique.plantaz@ujf-grenoble.fr | |
| CHU de la Timone | Recruiting |
| Marseille, France, 13385 | |
| Contact: Carole Coze 33-91-385-708 | |
| CHU de Nancy - Hopitaux de Brabois | Recruiting |
| Vandoeuvre-Les-Nancy, France, 54511 | |
| Contact: Pascal Chastagner 33-038-315-4621 | |
| CHU Sainte-Etienne - Hopital Nord | Recruiting |
| Sainte-Etienne, France, 42055 | |
| Contact: J. Louis Stephan 33-4-77-82-80-00 | |
| Hopital Americain | Recruiting |
| Reims, France, 51092 | |
| Contact: Catherine Behar, MD 33-26-787-515 | |
| Centre Leon Berard | Recruiting |
| Lyon, France, 69373 | |
| Contact: Didier Frappaz, MD 33-4-78-782881 frappa2@lyon.fnclcc.fr | |
| Hopital Charles Nicolle | Recruiting |
| Rouen, France, 76031 | |
| Contact: J.P. Vannier 33-2-3288-89-90 | |
| Hopital Jean Bernard | Recruiting |
| Poitiers, France, 86021 | |
| Contact: Frederic Millot, MD 33-05-49-444-201 f.millot@chu-poitiers.fr | |
| Hopital Saint Antoine Lille | Recruiting |
| Lille, France, 59000 | |
| Contact: Francois Dusol, MD 33-20-78-31-31 | |
| Hopital Sud | Recruiting |
| Rennes, France, 35056 | |
| Contact: Christophe Bergeron 33-02-9928-4321 | |
| Hopitaux Universitaire de Strasbourg | Recruiting |
| Strasbourg, France, 67091 | |
| Contact: Patrick Lutz, MD 33-388-116-768 ext. 61010 | |
| Institut Curie Hopital | Recruiting |
| Paris, France, 75248 | |
| Contact: Jean Marie Michon, MD 33-1-44-324-558 jean.michon@curie.net | |
| Institut Gustave Roussy | Recruiting |
| Villejuif, France, F-94805 | |
| Contact: Olivier Hartmann 33-1-42-11-4211 | |
| Ireland | |
| Our Lady's Hospital for Sick Children Crumlin | Recruiting |
| Dublin, Ireland, 12 | |
| Contact: Fin Breatnach, MD, FRCPE 353-1-409-6659 fin.breatnach@olhsc.ie | |
| Italy | |
| Azienda Ospedaliera - Universitaria di Modena | Recruiting |
| Modena, Italy, 41100 | |
| Contact: Fausto Massolo 39-059-422-4373 | |
| Azienda Ospedaliera di Padova | Recruiting |
| Padova, Italy, 35128 | |
| Contact: Modesto Carli, MD 39-049-821-3579 modesto.carli@unipd.it | |
| Azienda Ospedaliera Di Parma | Recruiting |
| Parma, Italy, 43100 | |
| Contact: Giancarlo Izzi 39-521-702-441 | |
| Azienda Policlinico Umberto Primo | Recruiting |
| Rome, Italy, 00161 | |
| Contact: Manuel A. Castello 39-06-857-951 | |
| Ospedale Galliera | Recruiting |
| Genoa, Italy, 16128 | |
| Contact: Marco Cominetti 39-010-56-321 | |
| Clinica Pediatrica I | Recruiting |
| Naplesi, Italy, 480138 | |
| Contact: Maria Teresa Di Tullio 39-081-445-255 | |
| Clinica Pediatrica Palermo | Recruiting |
| Palermo, Italy, 90134 | |
| Contact: Margherita Lo Curto 39-091-485-292 | |
| Clinica Pediatrica Trieste | Recruiting |
| Trieste, Italy | |
| Contact: Paolo Tamaro 39-040-378-5380 | |
| Federico II University Medical School | Recruiting |
| Naples, Italy, 80131 | |
| Contact: Amadeo Fiorillo 39-081-746-3772 | |
| Fondazione I.R.C.C.S. Policlinico San Matteo | Recruiting |
| Pavia, Italy, 27100 | |
| Contact: Frederico Bonetti 39-0382-502-580 | |
| Fondazione Istituto Nazionale dei Tumori | Recruiting |
| Milan, Italy, 20133 | |
| Contact: Marco Gasparini, MD 02-2390587 | |
| Istituti Clinici di Perfezionamento | Recruiting |
| Milan, Italy, 20122 | |
| Contact: Maria Fagnani 39-2-5799-1 | |
| Istituto Clinica Medica | Recruiting |
| Sassari, Italy, 07100 | |
| Contact: Domenico Gallisai 39-079-228-382 | |
| Istituto Giannina Gaslini | Recruiting |
| Genoa, Italy, 16148 | |
| Contact: Bruno De Bernardi, MD 39-10-563-6464 brunodebernardi@ospedale-gaslini.ge.it | |
| Ospedale Bambino Gesu | Recruiting |
| Rome, Italy, 00165 | |
| Contact: Alberto Donfrancesco 39-06-6859-2351 | |
| Clinica Ars Medica | Recruiting |
| Rome, Italy, 00191 | |
| Contact: Antonia Mancini 39-06-3620-8502 | |
| Ospedale Infantile Regina Margherita | Recruiting |
| Turin, Italy, 10126 | |
| Contact: Luca Cordero Di Montezemolo 39-011-692-7230 | |
| Ospedale Niguarda Ca'Granda | Recruiting |
| Milan, Italy, 20162 | |
| Contact: Alvaro Moreno 39-02-6444-2291 | |
| Ospedale Oncologico A. Businco | Recruiting |
| Cagliari, Italy, 09121 | |
| Contact: Roberto Targhetta 39-070-609-5204 | |
| Ospedale S.S. Annunziata Napoli | Recruiting |
| Naples, Italy, 80100 | |
| Contact: Antonio Correra 39-081-254-2588 | |
| Ospedale Santa Chiara Pisa | Recruiting |
| Pisa, Italy, 56100 | |
| Contact: Claudio Favre 39-50-992-540 | |
| Ospedale Silvestrini | Recruiting |
| Perugia, Italy, 06132 | |
| Contact: Paolo Zucchetti 39-075-578-3392 | |
| Ospedali Riuniti di Bergamo | Recruiting |
| Bergamo, Italy, 24100 | |
| Contact: Piermemilio Cornelli 39-035-269-859 | |
| Policlinico Dell'Universita | Recruiting |
| Catania, Italy, 95125 | |
| Contact: Gino Schilliro 39-095-330-533 | |
| Spedali Civili di Brescia | Recruiting |
| Brescia, Italy, 25123 | |
| Contact: Alberto Arrighini 39-030-395-823 | |
| Universita Degli Studi di Bari | Recruiting |
| Bari, Italy, 70124 | |
| Contact: Serenella Bagnulo 39-080-5478-660 | |
| University of Siena | Recruiting |
| Siena, Italy, 53100 | |
| Contact: Antonio Acquaviva 39-0577-280-921 | |
| Netherlands | |
| Academisch Medisch Centrum at University of Amsterdam | Recruiting |
| Amsterdam, Netherlands, 1100 DE | |
| Contact: Jan DeKraker, MD 31-20-566-9111 j.dekraker@amc.uva.nl | |
| University Medical Center Groningen | Recruiting |
| Groningen, Netherlands, 9700 RB | |
| Contact: Willem A. Kamps, MD, PhD 31-50-361-4213 w.a.kamps@bkk.umcg.nl | |
| Spain | |
| Complejo Hospitalario Xeral de Vigo | Recruiting |
| Vigo Pontevedra, Spain, 36204 | |
| Contact: Contact Person 34-98-681-6000 | |
| Hospital de la Santa Cruz i Sant Pau | Recruiting |
| Barcelona, Spain, 08025 | |
| Contact: Josep Cubells Riero 34-93-291-9440 | |
| Hospital Des Cruces | Recruiting |
| Vizcaya, Spain, 48 | |
| Contact: Aurora Navajas 34-94-600-6000 | |
| Hospital General de Galicia | Recruiting |
| Santiago de Compostela, Spain, 15705 | |
| Contact: J. Miguel Couselo 34-981-540-000 | |
| Hospital General Universitario Gregorio Maranon | Recruiting |
| Madrid, Spain, 28007 | |
| Contact: Maria Angeles Cantalejo 34-91-586-8598 | |
| Hospital Universitario La Fe | Recruiting |
| Valencia, Spain, 46009 | |
| Contact: Victoria Castel 34-96-386-2700 | |
| Hospital Regional Carlos Haya De Malaga | Recruiting |
| Malaga, Spain, 29010 | |
| Contact: Antonio Urda 34-95-227-7400 | |
| Hospital Universitario 12 de Octubre | Recruiting |
| Madrid, Spain, 28041 | |
| Contact: Jesus Lopez Perez 34-91-390-8000 | |
| Hospital Universitario Central de Asturias | Recruiting |
| Oviedo, Spain, 33006 | |
| Contact: Jesus Antuna 34-98-510-6112 | |
| Hospital Universitario de Canarias | Recruiting |
| San Cristobal de La Laguna, Spain, 38320 | |
| Contact: J. Rodriguez Luis 34-92-267-8000 | |
| Hospital Ramon y Cajal | Recruiting |
| Madrid, Spain, 28034 | |
| Contact: Arturo Munoz Villa 34-91-336-8263 | |
| Hospital Universitario La Paz | Recruiting |
| Madrid, Spain, 28046 | |
| Contact: Purificacion Garcia Miguel 34-91-727-7000 | |
| Hospital Universitario Miguel Servet | Recruiting |
| Zaragoza, Spain, 50009 | |
| Contact: Carlota Calvo 34-97-676-5510 | |
| Vall d'Hebron University Hospital | Recruiting |
| Barcelona, Spain, 08035 | |
| Contact: Jose M. Sanchez De Toledo 34-93-274-6077 | |
| Switzerland | |
| Hopital des Enfants | Recruiting |
| Geneva, Switzerland, 1211 | |
| Contact: Contact Person 41-22-382-4568 | |
| Kantonspital Aarau | Recruiting |
| Aarau, Switzerland, CH-5001 | |
| Contact: Paul A. Imbach, MD 41-62-838-4913 | |
| Ostschweizer Kinderspital | Recruiting |
| St. Gallen, Switzerland, 9006 | |
| Contact: Andreas J. Feldges, MD 41-71-243-7381 andreas.feldges2@gd-kispi.sg | |
| United Kingdom, England | |
| Leicester Royal Infirmary | Recruiting |
| Leicester, England, United Kingdom, LE1 5WW | |
| Contact: Rosemary S. Shannon, MD 44-116-254-1414 | |
| Bristol Royal Hospital for Children | Recruiting |
| Bristol, England, United Kingdom, BS2 8BJ | |
| Contact: Annabel B.M. Foot 44-117-342-8520 | |
| Children's Hospital - Sheffield | Recruiting |
| Sheffield, England, United Kingdom, S10 2TH | |
| Contact: Mary P. Gerrard, MBChB, FRCP, FRCPCH 44-114-271-7366 mary.gerrard@sch.nhs.uk | |
| Christie Hospital | Recruiting |
| Manchester, England, United Kingdom, M20 4BX | |
| Contact: H. R. Gattamaneni, MD 44-161-446-3000 | |
| Great Ormond Street Hospital for Children | Recruiting |
| London, England, United Kingdom, WC1N 3JH | |
| Contact: Ian Malcolm Hann, MD 44-20-7829-8831 Ian.Hann@gosh-tr.nthames.nhs.uk | |
| Addenbrooke's Hospital | Recruiting |
| Cambridge, England, United Kingdom, CB2 2QQ | |
| Contact: V. Broadbent 44-1223-245-151 | |
| Northern Centre for Cancer Treatment at Newcastle General Hospital | Recruiting |
| Newcastle Upon Tyne, England, United Kingdom, NE4 6BE | |
| Contact: Andrew David J. Pearson, MD, FRCP, DCh 44-191-273-8811 ext. 24101 | |
| Oxford Radcliffe Hospital | Recruiting |
| Oxford, England, United Kingdom, 0X3 9DU | |
| Contact: C. Mitchell 44-1865-221-066 | |
| Queen's Medical Centre | Recruiting |
| Nottingham, England, United Kingdom, NG7 2UH | |
| Contact: David A. Walker 44-115-924-9924 ext 61727 david.walker@nottingham.ac.uk | |
| Royal Liverpool Children's Hospital, Alder Hey | Recruiting |
| Liverpool, England, United Kingdom, L12 2AP | |
| Contact: Heather P. McDowell, MD 44-151-293-3679 | |
| Royal Marsden - Surrey | Recruiting |
| Sutton, England, United Kingdom, SM2 5PT | |
| Contact: Charles Ross Pinkerton, MD 44-20-8642-6011 | |
| Southampton General Hospital | Recruiting |
| Southampton, England, United Kingdom, SO16 6YD | |
| Contact: Janice A. Kohler, MD, FRCP 44-23-8079-6942 | |
| University College of London Hospitals | Recruiting |
| London, England, United Kingdom, WIT 3AA | |
| Contact: Robert L. Souhami, MD, FRCP, FRCR 44-20-7636-8333 | |
| United Kingdom, Northern Ireland | |
| Royal Belfast Hospital for Sick Children | Recruiting |
| Belfast, Northern Ireland, United Kingdom, BT12 6BE | |
| Contact: S.I. Dempsey, MD 44-28-9063-2402 | |
| United Kingdom, Scotland | |
| Aberdeen Royal Infirmary | Recruiting |
| Aberdeen, Scotland, United Kingdom, AB25 2ZN | |
| Contact: D.J. King, MD 44-84-5456-6000 derek.king@arh.gampian.scot.nhs.uk | |
| Royal Hospital for Sick Children | Recruiting |
| Glasgow, Scotland, United Kingdom, G3 8SJ | |
| Contact: E.M. Simpson 44-141-201-0000 | |
| Royal Hospital for Sick Children | Recruiting |
| Edinburgh, Scotland, United Kingdom, EH9 1LF | |
| Contact: W. Hamish Wallace, MD 44-131-536-0426 | |
| United Kingdom, Wales | |
| Llandough Hospital | Recruiting |
| Llandough, Wales, United Kingdom, CF64 2XX | |
| Contact: D. Webb 44-029-2071-1711 | |
| Study Chair: | Jean Marie Michon, MD | Institut Curie Hopital |
More Information
| Study ID Numbers: | CDR0000065880, SIOP-95-1, EU-96053 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003122 History of Changes |
| Health Authority: | Unspecified |
|
localized resectable neuroblastoma localized unresectable neuroblastoma |
|
Neuroectodermal Tumors Neoplasms Neoplasms by Histologic Type Neuroectodermal Tumors, Primitive Neoplasms, Germ Cell and Embryonal |
Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors, Primitive, Peripheral Neuroblastoma Neoplasms, Glandular and Epithelial |
