Status:
UNKNOWN
Observation of Young Patients With Localized Neuroblastoma Who Have Undergone Surgery Only
Lead Sponsor:
Children's Cancer and Leukaemia Group
Conditions:
Long-term Effects Secondary to Cancer Therapy in Children
Neuroblastoma
Eligibility:
All Genders
Up to 20 years
Phase:
PHASE2
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 neuro...
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 ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed neuroblastoma or ganglioneuroblastoma
- Meets 1 of the following International Neuroblastoma Staging System (INSS) criteria:
- Stage 1
- Stage 2A or 2B meeting 1 of the following criteria:
- With or without N-myc amplification
- No evaluation of NMA
- Symptomatic spinal cord compression
- Stage 3\*
- Dumbbell syndrome with clinical signs of spinal cord compression\*
- NOTE: \*These patients are eligible for the study but do not undergo observation; instead they will undergo standard treatment
- Has undergone complete or gross surgical resection OR diagnostic surgical or needle biopsy
- No metastases within 1 month of diagnosis
- No skin metastases by clinical examination and MIBG scan
- Normal liver by CT scan or ultrasonography
- Normal chest X-ray (in case of nonthoracic primary site)
- PATIENT CHARACTERISTICS:
- Not specified
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior steroids allowed
- No prior chemotherapy
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00416559
Start Date
December 1 2004
Last Update
September 20 2013
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