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Home > "S" Clinical Trials Conditions > Surgery in Treating Patients With Neuroblastoma

Surgery in Treating Patients With Neuroblastoma



Surgery in Treating Patients With Neuroblastoma

For Condition: localized resectable neuroblastoma,localized unresectable neuroblastoma
Status: Recruiting
Sponsor(s): Societe Internationale d'Oncologie Pediatrique ,
Synopsis: RATIONALE: Surgery may be an effective treatment for neuroblastoma. PURPOSE: Phase II trial to study the effectiveness of surgery in treating patients who have neuroblastoma.
Details: 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:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /20 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Trial: Histologically proven International Neuroblastoma Staging System (INSS) stage IIA and IIB neuroblastoma without amplification of the N-myc oncogene - 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
JeanMichon,  Study Chair,  Institut Curie - Section Medicale

Great Ormond Street Hospital for Children NHS Trust *Recruiting*
London,  England,  WC1N 3JH
United Kingdom
Recruiting Ian  Hann 44-20-7829-8831

Ospedale Bambino Gesu *Recruiting*
Rome,  ,  00165
Italy
Recruiting Alberto  Donfrancesco 39-06-6859-2351

Universita di Padova *Recruiting*
Padova,  ,  35128
Italy
Recruiting Modesto  Carli 39-049-821-3579

Hospital Universitario Canarias *Recruiting*
La Laguna (Tenerife),  ,  38320
Spain
Recruiting J.  Luis 34-922-678-000

Hospital General Universitari Vall d'Hebron *Recruiting*
Barcelona,  ,  08035
Spain
Recruiting Jose  Sanchez De Toledo 34-93-274-6077

Ospedale Oncologico A. Businco *Recruiting*
Cagliari,  ,  09124
Italy
Recruiting Roberto  Targhetta 39-070-609-5204

Hospital Regional Carlos Haya De Malaga *Recruiting*
Malaga,  ,  29010
Spain
Recruiting Antonio  Urda 34-95-227-7400

Abteilung fur Kinder und Jugendliche des LKH *Recruiting*
Leoben,  ,  A-8700
Austria
Recruiting Ingomar  Mutz 43-3842-401 ext 2330

C.H. Bastien de Clocheville *Recruiting*
Tours,  ,  37044
France
Recruiting O.  Lejars 33-02-4747-4747

Academisch Medisch Centrum *Recruiting*
Amsterdam,  ,  1100 DE
Netherlands
Recruiting Jan  DeKraker 31-20-566-9111

Hopital Charles Nicolle *Recruiting*
Rouen,  ,  76031
France
Recruiting J.P.  Vannier 33-235-888-247 (clinique pneum

Clinica Ars Medica *Recruiting*
Rome,  ,  00191
Italy
Recruiting Antonia  Mancini 39-06-3620-8502

Azienda Policlinico Umberto Primo *Recruiting*
Rome,  ,  00161
Italy
Recruiting Manuel  Castello 39-06-857-951

Krankenhaus des Landes Kaernten *Recruiting*
Klagenfurt,  ,  9020
Austria
Recruiting Wilhelm  Kaulfersch 43-4222-538-22901

Hospital La Paz *Recruiting*
Madrid,  ,  28006
Spain
Recruiting Purificacion  Miguel 34-91-727-7000

Hospital Universitario Miguel Servet *Recruiting*
Zaragoza,  ,  50009
Spain
Recruiting Carlota  Calvo 34-976-765-510

Clinica Pediatrica Trieste *Recruiting*
Trieste,  , 
Italy
Recruiting Paolo  Tamaro 39-040-378-5380

Centre Oscar Lambret *Recruiting*
Lille,  ,  59020
France
Recruiting Marie  Baranzelli 03-20-29-59-56

Llandough Hospital *Recruiting*
Penarth,  Wales,  CF64 2XX
United Kingdom
Recruiting D.  Webb 44-029-2071-1711

C.H.U. Saint Etienne Hospital Nord *Recruiting*
Saint-Etienne,  ,  42055
France
Recruiting J.  Stephan 33-04-7782-7002

Ospedale Galliera Oncologia *Recruiting*
Genova (Genoa),  ,  16128
Italy
Recruiting Marco  Cominetti 39-010-56-321

Universita Degli Studi di Bari Policlinico *Recruiting*
Bari,  ,  70124
Italy
Recruiting Serenella  Bagnulo 39-080-547-8660

Clinica Pediatrica Palermo *Recruiting*
Palermo,  ,  90134
Italy
Recruiting Margherita  Curto 39-091-485-292

Addenbrooke's NHS Trust *Recruiting*
Cambridge,  England,  CB2 2QQ
United Kingdom
Recruiting V.  Broadbent 44-1223-245-151

Leicester Royal Infirmary *Recruiting*
Leicester,  England,  LE1 5WW
United Kingdom
Recruiting Rosemary  Shannon 44-116-254-1414

Royal Hospital for Sick Children *Recruiting*
Glasgow,  Scotland,  G3 8SJ
United Kingdom
Recruiting E.M.  Simpson 44-141-201-0000

Centre Antoine Lacassagne *Recruiting*
Nice,  ,  06189
France
Recruiting Antoine  Thyss 33-04-9203-1538

Allgemeines Krankenhaus der Stadt Wien *Recruiting*
Vienna,  ,  A-1090
Austria
Recruiting Konrad  Pillwein 43-1-40400

CHU de la Timone *Recruiting*
Marseille,  ,  13385
France
Recruiting Carole  Coze 33-91-385-708

Ospedale Silvestrini *Recruiting*
Perugia,  ,  06132
Italy
Recruiting Paolo  Zucchetti 39-075-578-3392

Hopital Jean Bernard *Recruiting*
Poitiers,  ,  86021
France
Recruiting Frederic  Millot 33-05-49-444-201

Royal Belfast Hospital for Sick Children *Recruiting*
Belfast,  Northern Ireland,  BT12 6BE
United Kingdom
Recruiting S.I.  Dempsey 44-28-9063-2402

Queen's Medical Centre *Recruiting*
Nottingham,  England,  NG7 2UH
United Kingdom
Recruiting David  Walker 44-115-924-9924

Hopital Saint Antoine Lille *Recruiting*
Lille,  ,  59000
France
Recruiting Francois  Dusol 33-20-78-31-31

Hospital Universitario LA FE *Recruiting*
Valencia,  ,  46009
Spain
Recruiting Victoria  Castel 34-96-386-2700

Centre Hospitalier Regional de Purpan *Recruiting*
Toulouse,  ,  31026
France
Recruiting Herve  Rubie 33-5-61-491-133

Hospital Des Cruces *Recruiting*
Vizcaya,  ,  48
Spain
Recruiting Aurora  Navajas 34-94-600-6000

Centre Leon Berard *Recruiting*
Lyon,  ,  69373
France
Recruiting Didier  Frappaz 33-4-78-782881

Royal Marsden Hospital - Sutton *Recruiting*
Sutton,  England,  SM2 5PT
United Kingdom
Recruiting Charles  Pinkerton 44-20-8661-3498

Hopital des Enfants *Recruiting*
Geneva,  ,  1211
Switzerland
Recruiting Marinette  Wyss 41-22-382-3311

Ospedale Maggiore Ca'Granda *Recruiting*
Milano (Milan),  ,  20162
Italy
Recruiting Alvaro  Moreno 39-02-6444-2291

Hopital Americain *Recruiting*
Reims,  ,  51092
France
Recruiting Catherine  Behar 33-26-787-515

CHU de Caen *Recruiting*
Caen,  ,  14033
France
Recruiting Patrick  Boutard 33-31-064-488

Ospedali Riuniti di Bergamo *Recruiting*
Bergamo,  ,  24100
Italy
Recruiting Piermemilio  Cornelli 39-035-269-859 ext. 931

Royal Liverpool Children's Hospital, Alder Hey *Recruiting*
Liverpool,  England,  L12 2AP
United Kingdom
Recruiting Heather  McDowell 44-151-228-4811

Southampton General Hospital *Recruiting*
Southampton,  England,  SO16 6YD
United Kingdom
Recruiting Janice  Kohler 170-379-6942

CHU de Grenoble - Hopital de la Tronche *Recruiting*
Grenoble,  ,  38043
France
Recruiting Dominique  Plantaz 33-476-76-5469

Hospital de la Santa Cruz I Sant Pau *Recruiting*
Barcelona,  ,  08025
Spain
Recruiting Josep  Riero 34-3-291-91-25

Azienda Ospedaliera Di Parma *Recruiting*
Parma,  ,  43100
Italy
Recruiting Giancarlo  Izzi 39-0521-991-441

Federico II University Medical School *Recruiting*
Naples (Napoli),  ,  80131
Italy
Recruiting Amadeo  Fiorillo 39-081-746-3772

Landeskrankenanstalten - Salzburg *Recruiting*
Salzburg,  ,  A-5020
Austria
Recruiting Heinz  Griegenberg 43-662-4482-2879

Children's Hospital - Sheffield *Recruiting*
Sheffield,  England,  S10 2TH
United Kingdom
Recruiting Mary  Gerrard 00-44-0114-271-7229

Hopitaux Universitaire de Strasbourg *Recruiting*
Strasbourg,  ,  67091
France
Recruiting Patrick  Lutz 33-388-116-768 ext. 61010

Our Lady's Hospital for Sick Children *Recruiting*
Crumlin,  ,  12
Ireland
Recruiting Fin  Breatnach 353-1-409-6659

Istituto Clinica Medica *Recruiting*
Sassari,  ,  07100
Italy
Recruiting Domenico  Gallisai 39-079-228-382

Hopital Sud *Recruiting*
Rennes,  ,  35056
France
Recruiting Christophe  Bergeron 33-02-9928-4321

Universita di Modena *Recruiting*
Modena,  ,  41100
Italy
Recruiting Fausto  Massolo 39-0594-224-373

Oxford Radcliffe Hospital *Recruiting*
Oxford,  England,  0X3 9DU
United Kingdom
Recruiting C.  Mitchell 44-1865-221-066

Academisch Ziekenhuis Groningen *Recruiting*
Groningen,  ,  9700 RB
Netherlands
Recruiting Willem  Kamps 31-50-361-4213

Hopital Arnaud de Villeneuve *Recruiting*
Montpellier,  ,  34295
France
Recruiting Genevieve  Margueritte 33-67-33-6630

I.R.C.C.S. Policlinico San Matteo *Recruiting*
Pavia,  ,  27100
Italy
Recruiting Frederico  Bonetti 39-0382-502-580

Ospedale Infantile Regina Margherita *Recruiting*
Turin (Torino),  ,  10126
Italy
Recruiting Luca  Di Montezemolo 39-011-692-7230

Policlinico Dell'Universita *Recruiting*
Catania,  ,  95125
Italy
Recruiting Gino  Schilliro 39-095-330-533

Ospedale S.S. Annunziata Napoli *Recruiting*
Napoli,  ,  80100
Italy
Recruiting Antonio  Correra 39-081-254-2588

Istitut Clinici Perfezwamento *Recruiting*
Milano,  ,  20122
Italy
Recruiting Maria  Fagnani 39-02-57-981

Meyerstein Institute of Oncology at Middlesex Hospital *Recruiting*
London,  England,  WIT 3AA
United Kingdom
Recruiting Robert  Souhami 44-20-7636-8333

University of Siena *Recruiting*
Siena,  ,  53100
Italy
Recruiting Antonio  Acquaviva 39-0577-280-921

Hospital General Gregorio Maranon *Recruiting*
Madrid,  ,  28007
Spain
Recruiting Maria  Cantalejo 34-91-586-8598

Kinderklinik *Recruiting*
St. Gallen,  ,  9006
Switzerland
Recruiting Andreas  Feldges 41-71-243-7381

Northern Centre for Cancer Treatment at Newcastle General Hospital *Recruiting*
Newcastle upon Tyne,  England,  NE4 6BE
United Kingdom
Recruiting Andrew  J. Pearson 44-191-273-8811 ext. 24101

Istituto Giannina Gaslini *Recruiting*
Genova,  ,  16148
Italy
Recruiting Bruno  Bernardi 39-10-563-6464

Ospedale Santa Chiara *Recruiting*
Pisa,  ,  56100
Italy
Recruiting Claudio  Favre 39-050-992-540

Aberdeen Royal Infirmary *Recruiting*
Aberdeen,  Scotland,  AB25 2ZN
United Kingdom
Recruiting D.J.  King 44-1224-681-818

Royal Hospital for Sick Children *Recruiting*
Edinburgh,  Scotland, 
United Kingdom
Recruiting Hamish  Wallace 0131-536-0426

Spedali Civili *Recruiting*
Brescia,  ,  25124
Italy
Recruiting Alberto  Arrighini 39-030-395-823

CHR Clermont Ferrand, Hotel dieu *Recruiting*
Clermont-Ferrand,  ,  63003
France
Recruiting F.  Demeocq 33-73-316-000

Innsbruck Universitaetsklinik *Recruiting*
Innsbruck,  ,  A-6020
Austria
Recruiting Franz  Fink 43-512-504-2971

CHU de Nancy - Hopitaux de Brabois *Recruiting*
Vandoeuvre-les-Nancy,  ,  54511
France
Recruiting Pascal  Chastagner 33-038-315-4621

Christie Hospital N.H.S. Trust *Recruiting*
Manchester,  England,  M20 4BX
United Kingdom
Recruiting H.R.  Gattamaneni 44-161-446-3000

Centre Hospitalier Universitaire de Dijon *Recruiting*
Dijon,  ,  21033
France
Recruiting G.  Couillault 33-380-293-031

Hospital General de Galicia *Recruiting*
Santiago de Compostela,  ,  15705
Spain
Recruiting J.  Couselo 34-981-540-000

CHR de Besancon - Hopital Saint-Jacques *Recruiting*
Besancon,  ,  25030
France
Recruiting Emmanuel  Plouvier 33-381-218-140

Hospital Universitario 12 de Octubre *Recruiting*
Madrid,  ,  28041
Spain
Recruiting Jesus  Perez 34-91-741-7780

Hospital Universitario Central de Asturias *Recruiting*
Oviedo,  ,  33006
Spain
Recruiting Jesus  Antuna 34-985-106-112

Institut Gustave Roussy *Recruiting*
Villejuif,  ,  F-94805
France
Recruiting Olivier  Hartmann 33-1-42-11-4211

Centre Hospital Regional Universitaire de Limoges *Recruiting*
Limoges,  ,  87042
France
Recruiting I.  Lumley 00-33-5-55-05-61-23

C.H.U. Armand Trousseau *Recruiting*
Paris,  ,  75571
France
Recruiting Guy  Leverger 33-1-4473-7475

Istituto Nazionale per lo Studio e la Cura dei Tumori *Recruiting*
Milan,  ,  20133
Italy
Recruiting Marco  Gasparini 02-2390587

Hospital Ramon y Cajal *Recruiting*
Madrid,  ,  28034
Spain
Recruiting Arturo  Villa 34-91-336-8263

Kantonspital Aarau *Recruiting*
AARAU,  ,  5001
Switzerland
Recruiting Paul  Imbach 41-62-838-6050

Institut Curie - Section Medicale *Recruiting*
Paris,  ,  75248
France
Recruiting Jean  Michon 33-1-44-324-558

Clinica Pediatrica I *Recruiting*
Napoli,  ,  480138
Italy
Recruiting Maria  Di Tullio 39-081-445-255

Centre Hospitalier Regional et Universitaire de Lille *Recruiting*
Lille,  ,  59037
France
Recruiting B.  Nelken 33-320-444-263

Universitaet Kinderklinik *Recruiting*
Graz,  ,  8036
Austria
Recruiting Christian  Urban 43-0316-385-2605

Complexo Hospitalario Xeral de Vigo *Recruiting*
Vigo Pontevedra,  ,  36204
Spain
Recruiting Christine  Soler 34-86-416-011

Bristol Royal Hospital for Children *Recruiting*
Bristol,  England,  BS2 8BJ
United Kingdom
Recruiting Annabel  Foot 44-117-921-5411


Additional Information:
Study ID Numbers:
  CDR0000065880;  SIOP-95-1,EU-96053
Study Start Date: 
Record last reviewed: January 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003122

Other Localized Resectable Neuroblastoma Studies:
1. Isotretinoin With or Without Monoclonal Antibody, Interleukin 2, and Sargramostim Following Stem Cell Transplantation in Treating Patients With Neuroblastoma

2. Cyclophosphamide and Prednisone With or Without Immunoglobulin in Treating Abnormal Muscle Movement in Patients With Neuroblastoma

3. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Tumors

4. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma

5. Surgery in Treating Patients With Neuroblastoma

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