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| ID | Type | Description | Link |
|---|---|---|---|
| SIOP-95-1 | |||
| EU-96053 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| surgical procedure | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and efficacy | ||
| Predictive factors of relapse and survival |
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DISEASE CHARACTERISTICS:
Trial: Histologically proven International Neuroblastoma Staging System (INSS) stage IIA and IIB neuroblastoma without amplification of the N-myc oncogene
Study: Histologically proven neuroblastoma
No metastases diagnosed within 1 month of study
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Marie Michon, MD | Institut Curie | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitaet Kinderklinik | Recruiting | Graz | 8036 | Austria |
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| Innsbruck Universitaetsklinik | Recruiting | Innsbruck | A-6020 | Austria |
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| Landeskrankenhaus Klagenfurt | Recruiting | Klagenfurt | 9026 | Austria |
|
| LKH Leoben | Recruiting | Leoben | A-8700 | Austria |
|
| St. Johanns-Spital | Recruiting | Salzburg | A-5020 | Austria |
|
| Allgemeines Krankenhaus - Universitatskliniken | Recruiting | Vienna | A-1090 | Austria |
|
| CHR de Besancon - Hopital Saint-Jacques | Recruiting | Besançon | 25030 | France |
|
| CHU de Caen | Recruiting | Caen | 14033 | France |
|
| CHR Clermont Ferrand, Hotel Dieu | Recruiting | Clermont-Ferrand | 63058 | France |
|
| Centre Hospitalier Universitaire de Dijon | Recruiting | Dijon | 21079 | France |
|
| CHU de Grenoble - Hopital de la Tronche | Recruiting | Grenoble | 38043 | France |
|
| Hopital Saint Antoine Lille | Recruiting | Lille | 59000 | France |
|
| Centre Oscar Lambret | Recruiting | Lille | 59020 | France |
|
| Centre Hospitalier Regional et Universitaire de Lille | Recruiting | Lille | 59037 | France |
|
| Centre Hospital Regional Universitaire de Limoges | Recruiting | Limoges | 87042 | France |
|
| Centre Leon Berard | Recruiting | Lyon | 69373 | France |
|
| CHU de la Timone | Recruiting | Marseille | 13385 | France |
|
| Hopital Arnaud de Villeneuve | Recruiting | Montpellier | 34295 | France |
|
| Centre Antoine Lacassagne | Recruiting | Nice | 06189 | France |
|
| Institut Curie Hopital | Recruiting | Paris | 75248 | France |
|
| Hopital Jean Bernard | Recruiting | Poitiers | 86021 | France |
|
| Hopital Americain | Recruiting | Reims | 51092 | France |
|
| Hopital Sud | Recruiting | Rennes | 35056 | France |
|
| Hopital Charles Nicolle | Recruiting | Rouen | 76031 | France |
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| CHU Sainte-Etienne - Hopital Nord | Recruiting | Saint-Étienne-d'Orthe | 42055 | France |
|
| Hopitaux Universitaire de Strasbourg | Recruiting | Strasbourg | 67091 | France |
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| Centre Hospitalier Regional de Purpan | Recruiting | Toulouse | 31026 | France |
|
| C.H. Bastien de Clocheville | Recruiting | Tours | 37044 | France |
|
| CHRU de Tours - Hopital Trousseau | Recruiting | Tours | 37044 | France |
|
| CHU de Nancy - Hopitaux de Brabois | Recruiting | Vandœuvre-lès-Nancy | 54511 | France |
|
| Institut Gustave Roussy | Recruiting | Villejuif | F-94805 | France |
|
| Our Lady's Hospital for Sick Children Crumlin | Recruiting | Dublin | 12 | Ireland |
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| Universita Degli Studi di Bari | Recruiting | Bari | 70124 | Italy |
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| Ospedali Riuniti di Bergamo | Recruiting | Bergamo | 24100 | Italy |
|
| Spedali Civili di Brescia | Recruiting | Brescia | 25123 | Italy |
|
| Ospedale Oncologico A. Businco | Recruiting | Cagliari | 09121 | Italy |
|
| Policlinico Dell'Universita | Recruiting | Catania | 95125 | Italy |
|
| Ospedale Galliera | Recruiting | Genoa | 16128 | Italy |
|
| Istituto Giannina Gaslini | Recruiting | Genoa | 16148 | Italy |
|
| Istituti Clinici di Perfezionamento | Recruiting | Milan | 20122 | Italy |
|
| Fondazione Istituto Nazionale dei Tumori | Recruiting | Milan | 20133 | Italy |
|
| Ospedale Niguarda Ca'Granda | Recruiting | Milan | 20162 | Italy |
|
| Azienda Ospedaliera - Universitaria di Modena | Recruiting | Modena | 41100 | Italy |
|
| Ospedale S.S. Annunziata Napoli | Recruiting | Naples | 80100 | Italy |
|
| Federico II University Medical School | Recruiting | Naples | 80131 | Italy |
|
| Clinica Pediatrica I | Recruiting | Naplesi | 480138 | Italy |
|
| Azienda Ospedaliera di Padova | Recruiting | Padova | 35128 | Italy |
|
| Clinica Pediatrica Palermo | Recruiting | Palermo | 90134 | Italy |
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| Azienda Ospedaliera Di Parma | Recruiting | Parma | 43100 | Italy |
|
| Fondazione I.R.C.C.S. Policlinico San Matteo | Recruiting | Pavia | 27100 | Italy |
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| Ospedale Silvestrini | Recruiting | Perugia | 06132 | Italy |
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| Ospedale Santa Chiara Pisa | Recruiting | Pisa | 56100 | Italy |
|
| Azienda Policlinico Umberto Primo | Recruiting | Rome | 00161 | Italy |
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| Ospedale Bambino Gesu | Recruiting | Rome | 00165 | Italy |
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| Clinica Ars Medica | Recruiting | Rome | 00191 | Italy |
|
| Istituto Clinica Medica | Recruiting | Sassari | 07100 | Italy |
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| University of Siena | Recruiting | Siena | 53100 | Italy |
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| Clinica Pediatrica Trieste | Recruiting | Trieste | Italy |
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| Ospedale Infantile Regina Margherita | Recruiting | Turin | 10126 | Italy |
|
| Academisch Medisch Centrum at University of Amsterdam | Recruiting | Amsterdam | 1100 DE | Netherlands |
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| University Medical Center Groningen | Recruiting | Groningen | 9700 RB | Netherlands |
|
| Hospital de la Santa Cruz i Sant Pau | Recruiting | Barcelona | 08025 | Spain |
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| Vall d'Hebron University Hospital | Recruiting | Barcelona | 08035 | Spain |
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| Hospital General Universitario Gregorio Maranon | Recruiting | Madrid | 28007 | Spain |
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| Hospital Ramon y Cajal | Recruiting | Madrid | 28034 | Spain |
|
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
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| Hospital Universitario La Paz | Recruiting | Madrid | 28046 | Spain |
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| Hospital Regional Carlos Haya De Malaga | Recruiting | Málaga | 29010 | Spain |
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| Hospital Universitario Central de Asturias | Recruiting | Oviedo | 33006 | Spain |
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| Hospital Universitario de Canarias | Recruiting | San Cristóbal de La Laguna | 38320 | Spain |
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| Hospital General de Galicia | Recruiting | Santiago de Compostela | 15705 | Spain |
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| Hospital Universitario La Fe | Recruiting | Valencia | 46009 | Spain |
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| Complejo Hospitalario Xeral de Vigo | Recruiting | Vigo Pontevedra | 36204 | Spain |
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| Hospital Des Cruces | Recruiting | Vizcaya | 48 | Spain |
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| Hospital Universitario Miguel Servet | Recruiting | Zaragoza | 50009 | Spain |
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| Kantonsspital Aarau | Recruiting | Aarau | CH-5001 | Switzerland |
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| Hopital des Enfants | Recruiting | Geneva | 1211 | Switzerland |
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| Ostschweizer Kinderspital | Recruiting | Sankt Gallen | 9006 | Switzerland |
|
| Bristol Royal Hospital for Children | Recruiting | Bristol | England | BS2 8BJ | United Kingdom |
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| Addenbrooke's Hospital | Recruiting | Cambridge | England | CB2 2QQ | United Kingdom |
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| Leicester Royal Infirmary | Recruiting | Leicester | England | LE1 5WW | United Kingdom |
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| Royal Liverpool Children's Hospital, Alder Hey | Recruiting | Liverpool | England | L12 2AP | United Kingdom |
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| Great Ormond Street Hospital for Children | Recruiting | London | England | WC1N 3JH | United Kingdom |
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| University College of London Hospitals | Recruiting | London | England | WIT 3AA | United Kingdom |
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| Christie Hospital | Recruiting | Manchester | England | M20 4BX | United Kingdom |
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| Northern Centre for Cancer Treatment at Newcastle General Hospital | Recruiting | Newcastle upon Tyne | England | NE4 6BE | United Kingdom |
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| Queen's Medical Centre | Recruiting | Nottingham | England | NG7 2UH | United Kingdom |
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| Oxford Radcliffe Hospital | Recruiting | Oxford | England | 0X3 9DU | United Kingdom |
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| Children's Hospital - Sheffield | Recruiting | Sheffield | England | S10 2TH | United Kingdom |
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| Southampton General Hospital | Recruiting | Southampton | England | SO16 6YD | United Kingdom |
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| Royal Marsden - Surrey | Recruiting | Sutton | England | SM2 5PT | United Kingdom |
|
| Royal Belfast Hospital for Sick Children | Recruiting | Belfast | Northern Ireland | BT12 6BE | United Kingdom |
|
| Aberdeen Royal Infirmary | Recruiting | Aberdeen | Scotland | AB25 2ZN | United Kingdom |
|
| Royal Hospital for Sick Children | Recruiting | Edinburgh | Scotland | EH9 1LF | United Kingdom |
|
| Royal Hospital for Sick Children | Recruiting | Glasgow | Scotland | G3 8SJ | United Kingdom |
|
| Llandough Hospital | Recruiting | Llandough | Wales | CF64 2XX | United Kingdom |
|
| ID | Term |
|---|---|
| D009447 | Neuroblastoma |
| ID | Term |
|---|---|
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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