Surgery in Treating Patients With Neuroblastoma

  • STATUS
    Recruiting
  • participants needed
    210
  • sponsor
    Societe Internationale d'Oncologie Pediatrique
Updated on 7 November 2020
Hopital Charles Nicolle (0.0 mi away) Contact
+18 other location

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.

Details
Condition Neuroblastoma
Treatment surgical procedure
Clinical Study IdentifierNCT00003122
SponsorSociete Internationale d'Oncologie Pediatrique
Last Modified on7 November 2020

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