Clinical trial NCT00003122: Surgery in Treating Patients With Neuroblastoma
Official title: Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Neuroblastoma
Keywords: localized resectable neuroblastoma
localized unresectable neuroblastoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 210
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

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