Surgery in Treating Patients With Neuroblastoma

Neuroblastoma Clinical Trial

Official title:

Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00003122
• Other study ID #: CDR0000065880
• Secondary ID: SIOP-95-1EU-9605
• Status: Recruiting
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: August 23, 2013
• Start date: December 1994

Study information

• Verified date: July 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 210
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 20 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuroblastoma

Intervention

Procedure:
• surgical procedure

Locations

Country	Name	City	State
Austria	Universitaet Kinderklinik	Graz
Austria	Innsbruck Universitaetsklinik	Innsbruck
Austria	Landeskrankenhaus Klagenfurt	Klagenfurt
Austria	LKH Leoben	Leoben
Austria	St. Johanns-Spital	Salzburg
Austria	Allgemeines Krankenhaus - Universitatskliniken	Vienna
France	CHR de Besancon - Hopital Saint-Jacques	Besancon
France	CHU de Caen	Caen
France	CHR Clermont Ferrand, Hotel Dieu	Clermont-Ferrand
France	Centre Hospitalier Universitaire de Dijon	Dijon
France	CHU de Grenoble - Hopital de la Tronche	Grenoble
France	Centre Hospitalier Regional et Universitaire de Lille	Lille
France	Centre Oscar Lambret	Lille
France	Hopital Saint Antoine Lille	Lille
France	Centre Hospital Regional Universitaire de Limoges	Limoges
France	Centre Leon Berard	Lyon
France	CHU de la Timone	Marseille
France	Hopital Arnaud de Villeneuve	Montpellier
France	Centre Antoine Lacassagne	Nice
France	Institut Curie Hopital	Paris
France	Hopital Jean Bernard	Poitiers
France	Hopital Americain	Reims
France	Hopital Sud	Rennes
France	Hopital Charles Nicolle	Rouen
France	CHU Sainte-Etienne - Hopital Nord	Sainte-Etienne
France	Hopitaux Universitaire de Strasbourg	Strasbourg
France	Centre Hospitalier Regional de Purpan	Toulouse
France	C.H. Bastien de Clocheville	Tours
France	CHRU de Tours - Hopital Trousseau	Tours
France	CHU de Nancy - Hopitaux de Brabois	Vandoeuvre-Les-Nancy
France	Institut Gustave Roussy	Villejuif
Ireland	Our Lady's Hospital for Sick Children Crumlin	Dublin
Italy	Universita Degli Studi di Bari	Bari
Italy	Ospedali Riuniti di Bergamo	Bergamo
Italy	Spedali Civili di Brescia	Brescia
Italy	Ospedale Oncologico A. Businco	Cagliari
Italy	Policlinico Dell'Universita	Catania
Italy	Istituto Giannina Gaslini	Genoa
Italy	Ospedale Galliera	Genoa
Italy	Fondazione Istituto Nazionale dei Tumori	Milan
Italy	Istituti Clinici di Perfezionamento	Milan
Italy	Ospedale Niguarda Ca'Granda	Milan
Italy	Azienda Ospedaliera - Universitaria di Modena	Modena
Italy	Federico II University Medical School	Naples
Italy	Ospedale S.S. Annunziata Napoli	Naples
Italy	Clinica Pediatrica I	Naplesi
Italy	Azienda Ospedaliera di Padova	Padova
Italy	Clinica Pediatrica Palermo	Palermo
Italy	Azienda Ospedaliera Di Parma	Parma
Italy	Fondazione I.R.C.C.S. Policlinico San Matteo	Pavia
Italy	Ospedale Silvestrini	Perugia
Italy	Ospedale Santa Chiara Pisa	Pisa
Italy	Azienda Policlinico Umberto Primo	Rome
Italy	Clinica Ars Medica	Rome
Italy	Ospedale Bambino Gesu	Rome
Italy	Istituto Clinica Medica	Sassari
Italy	University of Siena	Siena
Italy	Clinica Pediatrica Trieste	Trieste
Italy	Ospedale Infantile Regina Margherita	Turin
Netherlands	Academisch Medisch Centrum at University of Amsterdam	Amsterdam
Netherlands	University Medical Center Groningen	Groningen
Spain	Hospital de la Santa Cruz i Sant Pau	Barcelona
Spain	Vall d'Hebron University Hospital	Barcelona
Spain	Hospital General Universitario Gregorio Maranon	Madrid
Spain	Hospital Ramon y Cajal	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Regional Carlos Haya De Malaga	Malaga
Spain	Hospital Universitario Central de Asturias	Oviedo
Spain	Hospital Universitario de Canarias	San Cristobal de La Laguna
Spain	Hospital General de Galicia	Santiago de Compostela
Spain	Hospital Universitario La Fe	Valencia
Spain	Complejo Hospitalario Xeral de Vigo	Vigo Pontevedra
Spain	Hospital Des Cruces	Vizcaya
Spain	Hospital Universitario Miguel Servet	Zaragoza
Switzerland	Kantonsspital Aarau	Aarau
Switzerland	Hopital des Enfants	Geneva
Switzerland	Ostschweizer Kinderspital	St. Gallen
United Kingdom	Aberdeen Royal Infirmary	Aberdeen	Scotland
United Kingdom	Royal Belfast Hospital for Sick Children	Belfast	Northern Ireland
United Kingdom	Bristol Royal Hospital for Children	Bristol	England
United Kingdom	Addenbrooke's Hospital	Cambridge	England
United Kingdom	Royal Hospital for Sick Children	Edinburgh	Scotland
United Kingdom	Royal Hospital for Sick Children	Glasgow	Scotland
United Kingdom	Leicester Royal Infirmary	Leicester	England
United Kingdom	Royal Liverpool Children's Hospital, Alder Hey	Liverpool	England
United Kingdom	Llandough Hospital	Llandough	Wales
United Kingdom	Great Ormond Street Hospital for Children	London	England
United Kingdom	University College of London Hospitals	London	England
United Kingdom	Christie Hospital	Manchester	England
United Kingdom	Northern Centre for Cancer Treatment at Newcastle General Hospital	Newcastle Upon Tyne	England
United Kingdom	Queen's Medical Centre	Nottingham	England
United Kingdom	Oxford Radcliffe Hospital	Oxford	England
United Kingdom	Children's Hospital - Sheffield	Sheffield	England
United Kingdom	Southampton General Hospital	Southampton	England
United Kingdom	Royal Marsden - Surrey	Sutton	England

Sponsors (1)

Lead Sponsor	Collaborator
Societe Internationale d'Oncologie Pediatrique

Countries where clinical trial is conducted

Austria,  France,  Ireland,  Italy,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and efficacy			Yes
Primary	Predictive factors of relapse and survival			No