Observation of Young Patients With Localized Neuroblastoma Who Have Undergone Surgery Only
- Conditions
- Long-term Effects Secondary to Cancer Therapy in ChildrenNeuroblastoma
- Registration Number
- NCT00416559
- Lead Sponsor
- Children's Cancer and Leukaemia Group
- Brief Summary
RATIONALE: Observation is closely monitoring a patient's condition and not giving treatment until symptoms appear or change. Observation may help doctors see how effective surgery is in treating neuroblastoma.
PURPOSE: This phase II trial is studying how well surgery alone works in treating young patients with localized neuroblastoma.
- Detailed Description
OBJECTIVES:
Primary
* Evaluate the safety and efficacy of surgical treatment alone in young patients with stage 2 neuroblastoma without N-myc amplification (NMA).
Secondary
* Determine predictive factors of relapse and survival of patients with stage 1, 2A, or 2B neuroblastoma without NMA who have undergone surgery only.
OUTLINE: This is a nonrandomized, multicenter study.
Patients with stage 1 or 2 disease and no N-myc amplification (NMA) undergo observation comprising clinical evaluation, ultrasound or CT scan of the abdomen, and chest x-ray periodically for up to 5 years. All other patients undergo additional therapy and follow-up according to national standards. Patients who develop recurrent disease or disease progression may undergo surgical resection, preceded or followed by chemotherapy, according to national standards.
PROJECTED ACCRUAL: A total of 140 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 140
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and efficacy
- Secondary Outcome Measures
Name Time Method Predictive factors of relapse and survival