Clinical trial · Interventional
Observation of Young Patients With Localized Neuroblastoma Who Have Undergone Surgery Only
Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma
NCT00416559CI-TRIAL-00012220unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Long-term Effects Secondary to Cancer Therapy in Children | — | UNRESOLVED | — |
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| clinical observation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Safety and efficacy
Secondary outcomes (1)
- measure
- Predictive factors of relapse and survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 20 Years
Show eligibility criteria text
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 chemotherapyReferences
Publications (0)
Data not yet available
No reference posted for this study.