Surgery in Treating Patients With Neuroblastoma
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- STATUS
- Recruiting
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- participants needed
- 210
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- sponsor
- Societe Internationale d'Oncologie Pediatrique
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 Identifier | NCT00003122 |
| Sponsor | Societe Internationale d'Oncologie Pediatrique |
| Last Modified on | 7 November 2020 |
Eligibility
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