Surgery in Treating Patients With Neuroblastoma

NCT00003122 | Unknown Phase 2

• 3 other identifiers: CDR0000065880SIOP-95-1EU-96053
• Study Type: interventional
• Target: 210
• Locations: 8 countries
• Sites: 96

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.

Conditions

Neuroblastoma

Keywords

localized resectable neuroblastoma; localized unresectable neuroblastoma

Outcome Measures

Primary Outcomes (2)

• Safety and efficacy

• Predictive factors of relapse and survival

Interventions

surgical procedure PROCEDURE

Eligibility Criteria

• Age: Up to 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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 * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Societe Internationale d'Oncologie Pediatrique: lead

Study Sites (96)

Universitaet Kinderklinik

Graz, 8036, Austria

RECRUITING

Innsbruck Universitaetsklinik

Innsbruck, A-6020, Austria

RECRUITING

Landeskrankenhaus Klagenfurt

Klagenfurt, 9026, Austria

RECRUITING

LKH Leoben

Leoben, A-8700, Austria

RECRUITING

St. Johanns-Spital

Salzburg, A-5020, Austria

RECRUITING

Allgemeines Krankenhaus - Universitatskliniken

Vienna, A-1090, Austria

RECRUITING

CHR de Besancon - Hopital Saint-Jacques

Besançon, 25030, France

RECRUITING

CHU de Caen

Caen, 14033, France

RECRUITING

CHR Clermont Ferrand, Hotel Dieu

Clermont-Ferrand, 63058, France

RECRUITING

Centre Hospitalier Universitaire de Dijon

Dijon, 21079, France

RECRUITING

CHU de Grenoble - Hopital de la Tronche

Grenoble, 38043, France

RECRUITING

Hopital Saint Antoine Lille

Lille, 59000, France

RECRUITING

Centre Oscar Lambret

Lille, 59020, France

RECRUITING

Centre Hospitalier Regional et Universitaire de Lille

Lille, 59037, France

RECRUITING

Centre Hospital Regional Universitaire de Limoges

Limoges, 87042, France

RECRUITING

Centre Leon Berard

Lyon, 69373, France

RECRUITING

CHU de la Timone

Marseille, 13385, France

RECRUITING

Hopital Arnaud de Villeneuve

Montpellier, 34295, France

RECRUITING

Centre Antoine Lacassagne

Nice, 06189, France

RECRUITING

Institut Curie Hopital

Paris, 75248, France

RECRUITING

Hopital Jean Bernard

Poitiers, 86021, France

RECRUITING

Hopital Americain

Reims, 51092, France

RECRUITING

Hopital Sud

Rennes, 35056, France

RECRUITING

Hopital Charles Nicolle

Rouen, 76031, France

RECRUITING

CHU Sainte-Etienne - Hopital Nord

Saint-Étienne-d'Orthe, 42055, France

RECRUITING

Hopitaux Universitaire de Strasbourg

Strasbourg, 67091, France

RECRUITING

Centre Hospitalier Regional de Purpan

Toulouse, 31026, France

RECRUITING

C.H. Bastien de Clocheville

Tours, 37044, France

RECRUITING

CHRU de Tours - Hopital Trousseau

Tours, 37044, France

RECRUITING

CHU de Nancy - Hopitaux de Brabois

Vandœuvre-lès-Nancy, 54511, France

RECRUITING

Institut Gustave Roussy

Villejuif, F-94805, France

RECRUITING

Our Lady's Hospital for Sick Children Crumlin

Dublin, 12, Ireland

RECRUITING

Universita Degli Studi di Bari

Bari, 70124, Italy

RECRUITING

Ospedali Riuniti di Bergamo

Bergamo, 24100, Italy

RECRUITING

Spedali Civili di Brescia

Brescia, 25123, Italy

RECRUITING

Ospedale Oncologico A. Businco

Cagliari, 09121, Italy

RECRUITING

Policlinico Dell'Universita

Catania, 95125, Italy

RECRUITING

Ospedale Galliera

Genoa, 16128, Italy

RECRUITING

Istituto Giannina Gaslini

Genoa, 16148, Italy

RECRUITING

Istituti Clinici di Perfezionamento

Milan, 20122, Italy

RECRUITING

Fondazione Istituto Nazionale dei Tumori

Milan, 20133, Italy

RECRUITING

Ospedale Niguarda Ca'Granda

Milan, 20162, Italy

RECRUITING

Azienda Ospedaliera - Universitaria di Modena

Modena, 41100, Italy

RECRUITING

Ospedale S.S. Annunziata Napoli

Naples, 80100, Italy

RECRUITING

Federico II University Medical School

Naples, 80131, Italy

RECRUITING

Clinica Pediatrica I

Naplesi, 480138, Italy

RECRUITING

Azienda Ospedaliera di Padova

Padua, 35128, Italy

RECRUITING

Clinica Pediatrica Palermo

Palermo, 90134, Italy

RECRUITING

Azienda Ospedaliera Di Parma

Parma, 43100, Italy

RECRUITING

Fondazione I.R.C.C.S. Policlinico San Matteo

Pavia, 27100, Italy

RECRUITING

Ospedale Silvestrini

Perugia, 06132, Italy

RECRUITING

Ospedale Santa Chiara Pisa

Pisa, 56100, Italy

RECRUITING

Azienda Policlinico Umberto Primo

Rome, 00161, Italy

RECRUITING

Ospedale Bambino Gesu

Rome, 00165, Italy

RECRUITING

Clinica Ars Medica

Rome, 00191, Italy

RECRUITING

Istituto Clinica Medica

Sassari, 07100, Italy

RECRUITING

University of Siena

Siena, 53100, Italy

RECRUITING

Clinica Pediatrica Trieste

Trieste, Italy

RECRUITING

Ospedale Infantile Regina Margherita

Turin, 10126, Italy

RECRUITING

Academisch Medisch Centrum at University of Amsterdam

Amsterdam, 1100 DE, Netherlands

RECRUITING

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

RECRUITING

Hospital de la Santa Cruz i Sant Pau

Barcelona, 08025, Spain

RECRUITING

Vall d'Hebron University Hospital

Barcelona, 08035, Spain

RECRUITING

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

RECRUITING

Hospital Ramon y Cajal

Madrid, 28034, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Hospital Regional Carlos Haya De Malaga

Málaga, 29010, Spain

RECRUITING

Hospital Universitario Central de Asturias

Oviedo, 33006, Spain

RECRUITING

Hospital Universitario de Canarias

San Cristóbal de La Laguna, 38320, Spain

RECRUITING

Hospital General de Galicia

Santiago de Compostela, 15705, Spain

RECRUITING

Hospital Universitario La Fe

Valencia, 46009, Spain

RECRUITING

Complejo Hospitalario Xeral de Vigo

Vigo Pontevedra, 36204, Spain

RECRUITING

Hospital Des Cruces

Vizcaya, 48, Spain

RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

RECRUITING

Kantonsspital Aarau

Aarau, CH-5001, Switzerland

RECRUITING

Hopital des Enfants

Geneva, 1211, Switzerland

RECRUITING

Ostschweizer Kinderspital

Sankt Gallen, 9006, Switzerland

RECRUITING

Bristol Royal Hospital for Children

Bristol, England, BS2 8BJ, United Kingdom

RECRUITING

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

RECRUITING

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

RECRUITING

Royal Liverpool Children's Hospital, Alder Hey

Liverpool, England, L12 2AP, United Kingdom

RECRUITING

Great Ormond Street Hospital for Children

London, England, WC1N 3JH, United Kingdom

RECRUITING

University College of London Hospitals

London, England, WIT 3AA, United Kingdom

RECRUITING

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

RECRUITING

Northern Centre for Cancer Treatment at Newcastle General Hospital

Newcastle upon Tyne, England, NE4 6BE, United Kingdom

RECRUITING

Queen's Medical Centre

Nottingham, England, NG7 2UH, United Kingdom

RECRUITING

Oxford Radcliffe Hospital

Oxford, England, 0X3 9DU, United Kingdom

RECRUITING

Children's Hospital - Sheffield

Sheffield, England, S10 2TH, United Kingdom

RECRUITING

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

RECRUITING

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

RECRUITING

Royal Belfast Hospital for Sick Children

Belfast, Northern Ireland, BT12 6BE, United Kingdom

RECRUITING

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

RECRUITING

Royal Hospital for Sick Children

Edinburgh, Scotland, EH9 1LF, United Kingdom

RECRUITING

Royal Hospital for Sick Children

Glasgow, Scotland, G3 8SJ, United Kingdom

RECRUITING

Llandough Hospital

Llandough, Wales, CF64 2XX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Neuroblastoma

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Jean Marie Michon, MD

  Institut Curie

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: December 1, 1994
• Last Updated: August 26, 2013

Record last verified: 2007-07

Locations

IE (1); CH (3); IT (27); NL (2); ES (14); AU (6); FR (25); GB (18)