Surgery in Treating Patients With Neuroblastoma
Recruitment status was Recruiting
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma|
- Safety and efficacy [ Designated as safety issue: Yes ]
- Predictive factors of relapse and survival [ Designated as safety issue: No ]
|Study Start Date:||December 1994|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003122
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|Study Chair:||Jean Marie Michon, MD||Institut Curie|