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| ID | Type | Description | Link |
|---|---|---|---|
| CCLG-NB-1995-06 | |||
| EU-20596 | |||
| CCLG-94-01 |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clinical observation | Other |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and efficacy |
| Measure | Description | Time Frame |
|---|---|---|
| Predictive factors of relapse and survival |
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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:
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
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Bruno De Bernardi, MD | Istituto Giannina Gaslini | Study Chair |
| Jean Marie Michon, MD | Institut Curie |
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| ID | Term |
|---|---|
| D009447 | Neuroblastoma |
| ID | Term |
|---|---|
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |