NCT00003122

Surgery in Treating Patients With Neuroblastoma

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Societe Internationale d'Oncologie Pediatrique · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neuroblastoma

Interventions

Type	Name	Description
PROCEDURE	surgical procedure

Timeline

• Start date: 1994-12-01
• First posted: 2003-01-27
• Last updated: 2013-08-26

Locations

96 sites across 8 countries: Austria, France, Ireland, Italy, Netherlands, Spain, Switzerland, United Kingdom