Surgery in Treating Patients With Neuroblastoma

Phase 2

• Conditions: Neuroblastoma

• Registration Number: NCT00003122
• Lead Sponsor: Societe Internationale d'Oncologie Pediatrique

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.

Study Timeline

• Study Start: 1994-12
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2007-07
• Last Update Submitted: 2013-08-23
• Last Update Posted: 2013-08-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Predictive factors of relapse and survival
Safety and efficacy

Trial Locations

Locations (95)

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, Austria

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

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